Trial Outcomes & Findings for The Role of Acute Combined PPAR Alpha and Gamma Stimulation on Insulin Action in Humans (NCT NCT00179400)
NCT ID: NCT00179400
Last Updated: 2025-03-03
Results Overview
EGP (a measure of the body's production of sugar) was measured by using a 6-hour stepped pancreatic clamp procedure under various treatment conditions (e.g., Pioglitazone or placebo at 10-days and/or 21-days), by monitoring the level of a non-radioactive, naturally occurring form of glucose (sugar). The relevant data at the end of each last 60 minute bin of each run was reported for each of the four groups up to 6 hours. Results are summarized by study arm/group and reported in milligrams/kilograms/minute (mg/kg/min).
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
26 participants
Primary outcome timeframe
Up to 6 hours
Results posted on
2025-03-03
Participant Flow
A total of 26 adult volunteers with type 2 diabetes completed the 10-day and/or the 21-day protocols. 13 participants completed the 10-day studies, and 13 completed the 21-day studies. Three subjects participated in both the 10-day and 21-day studies, more than six months apart.
Participant milestones
| Measure |
2000-200 10-day Study Only
Participants received either 45mg of Pioglitazone (pio) or Placebo (matched to Pioglitazone) via oral capsule daily for 10 days, in randomized, placebo-controlled, cross-over fashion. Following a 4 week wash-out period, participants were crossed over to the corresponding intervention (45mg of Pioglitazone or Placebo) via oral capsule daily for 10 days.
The investigators used a research procedure called a "pancreatic clamp" study to investigate the effects of pioglitazone. During the clamp procedure, glucose (a sugar) and insulin (a hormone that regulates the amount of glucose in the blood) are infused with an intravenous catheter, and blood samples are collected periodically throughout the procedure to measure blood sugar levels and the levels of several hormones that are found in the body and are related to glucose metabolism.
|
2000-200 21-day Study Only
Participants received either 45mg of Pioglitazone (pio) or Placebo (matched to Pioglitazone) via oral capsule daily for 21 days, in randomized, placebo-controlled, cross-over fashion. Following a 4 week wash-out period, participants were crossed over to the corresponding intervention (45mg of Pioglitazone or Placebo) via oral capsule daily for 21 days.
The investigators used a research procedure called a "pancreatic clamp" study to study the effects of pioglitazone. During the clamp procedure, glucose (a sugar) and insulin (a hormone that regulates the amount of glucose in the blood) are infused with an intravenous catheter, and blood samples are collected periodically throughout the procedure to measure blood sugar levels and the levels of several hormones that are found in the body and are related to glucose metabolism.
|
2000-200 10-day and 21-day Study
Participants received either 45mg of Pioglitazone (pio) or Placebo (matched to Pioglitazone) via oral capsule daily for 10 days, in randomized, placebo-controlled, cross-over fashion. Following a 4 week wash-out period, participants were crossed over to the corresponding intervention (45mg of Pioglitazone or Placebo) via oral capsule daily for 10 days.
The investigators used a research procedure called a "pancreatic clamp" study to investigate the effects of pioglitazone. During the clamp procedure, glucose (a sugar) and insulin (a hormone that regulates the amount of glucose in the blood) are infused with an intravenous catheter, and blood samples are collected periodically throughout the procedure to measure blood sugar levels and the levels of several hormones that are found in the body and are related to glucose metabolism.
|
|---|---|---|---|
|
Overall Study
STARTED
|
13
|
13
|
0
|
|
Overall Study
Placebo First 10 Day
|
6
|
0
|
0
|
|
Overall Study
Pioglitazone First 10 Day
|
7
|
0
|
0
|
|
Overall Study
Placebo First 21 Day
|
0
|
6
|
1
|
|
Overall Study
Pioglitazone First 21 Day
|
0
|
7
|
2
|
|
Overall Study
COMPLETED
|
13
|
13
|
0
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
For age, the mean and measure of dispersion were reported for the 16 participants completing the 21-day study of pioglitazone/placebo. For the 13 participants completing the 10-day study of pioglitazone/placebo, the mean age and standard error were also reported.
Baseline characteristics by cohort
| Measure |
2000-200 10-day Study
n=13 Participants
Participants received either 45mg of Pioglitazone (pio) or Placebo (matched to Pioglitazone) via oral capsule daily for 10 days, in randomized, placebo-controlled, cross-over fashion. Following a 4 week wash-out period, participants were crossed over to the corresponding intervention (45mg of Pioglitazone or Placebo) via oral capsule daily for 10 days.
The investigators used a research procedure called a "pancreatic clamp" study to investigate the effects of pioglitazone. During the clamp procedure, glucose (a sugar) and insulin (a hormone that regulates the amount of glucose in the blood) are infused with an intravenous catheter, and blood samples are collected periodically throughout the procedure to measure blood sugar levels and the levels of several hormones that are found in the body and are related to glucose metabolism.
|
2000-200 21-day Study
n=13 Participants
Participants received either 45mg of Pioglitazone (pio) or Placebo (matched to Pioglitazone) via oral capsule daily for 21 days, in randomized, placebo-controlled, cross-over fashion. Following a 4 week wash-out period, participants were crossed over to the corresponding intervention (45mg of Pioglitazone or Placebo) via oral capsule daily for 21 days.
The investigators used a research procedure called a "pancreatic clamp" study to investigate the effects of pioglitazone. During the clamp procedure, glucose (a sugar) and insulin (a hormone that regulates the amount of glucose in the blood) are infused with an intravenous catheter, and blood samples are collected periodically throughout the procedure to measure blood sugar levels and the levels of several hormones that are found in the body and are related to glucose metabolism.
|
Total
n=26 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
45.85 years
n=13 Participants • For age, the mean and measure of dispersion were reported for the 16 participants completing the 21-day study of pioglitazone/placebo. For the 13 participants completing the 10-day study of pioglitazone/placebo, the mean age and standard error were also reported.
|
47.88 years
n=13 Participants • For age, the mean and measure of dispersion were reported for the 16 participants completing the 21-day study of pioglitazone/placebo. For the 13 participants completing the 10-day study of pioglitazone/placebo, the mean age and standard error were also reported.
|
46.86 years
n=26 Participants • For age, the mean and measure of dispersion were reported for the 16 participants completing the 21-day study of pioglitazone/placebo. For the 13 participants completing the 10-day study of pioglitazone/placebo, the mean age and standard error were also reported.
|
|
Sex: Female, Male
Female
|
8 Participants
n=13 Participants • For baseline sex/gender, the number is reported for the 13 participants completing the 21-day course, for the 10 participants completing the 10-day course, and 3 participants completing both 10- and 21-day course of pioglitazone/placebo intervention. Total number of participants is 26.
|
8 Participants
n=13 Participants • For baseline sex/gender, the number is reported for the 13 participants completing the 21-day course, for the 10 participants completing the 10-day course, and 3 participants completing both 10- and 21-day course of pioglitazone/placebo intervention. Total number of participants is 26.
|
16 Participants
n=26 Participants • For baseline sex/gender, the number is reported for the 13 participants completing the 21-day course, for the 10 participants completing the 10-day course, and 3 participants completing both 10- and 21-day course of pioglitazone/placebo intervention. Total number of participants is 26.
|
|
Sex: Female, Male
Male
|
5 Participants
n=13 Participants • For baseline sex/gender, the number is reported for the 13 participants completing the 21-day course, for the 10 participants completing the 10-day course, and 3 participants completing both 10- and 21-day course of pioglitazone/placebo intervention. Total number of participants is 26.
|
5 Participants
n=13 Participants • For baseline sex/gender, the number is reported for the 13 participants completing the 21-day course, for the 10 participants completing the 10-day course, and 3 participants completing both 10- and 21-day course of pioglitazone/placebo intervention. Total number of participants is 26.
|
10 Participants
n=26 Participants • For baseline sex/gender, the number is reported for the 13 participants completing the 21-day course, for the 10 participants completing the 10-day course, and 3 participants completing both 10- and 21-day course of pioglitazone/placebo intervention. Total number of participants is 26.
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
13 number of participants
n=13 Participants
|
13 number of participants
n=13 Participants
|
26 number of participants
n=26 Participants
|
PRIMARY outcome
Timeframe: Up to 6 hoursEGP (a measure of the body's production of sugar) was measured by using a 6-hour stepped pancreatic clamp procedure under various treatment conditions (e.g., Pioglitazone or placebo at 10-days and/or 21-days), by monitoring the level of a non-radioactive, naturally occurring form of glucose (sugar). The relevant data at the end of each last 60 minute bin of each run was reported for each of the four groups up to 6 hours. Results are summarized by study arm/group and reported in milligrams/kilograms/minute (mg/kg/min).
Outcome measures
| Measure |
2000-200 Study 10-day Pioglitazone
n=13 Participants
Participants received Pioglitazone (pio) 45mg via oral unmarked capsule daily for 10 days with a wash-out period of at least 4 weeks between studies. This is a randomized, double blinded, cross-over study, so subjects who participated in the pioglitazone intervention also participated in the placebo intervention. Either placebo or pioglitazone was administered to each subject randomly for the study.
The investigators used a research procedure called a "pancreatic clamp" study to study the effects of pioglitazone. During the clamp procedure, glucose (a sugar) and insulin (a hormone that regulates the amount of glucose in the blood) are infused with an intravenous catheter, and blood samples are collected periodically throughout the procedure to measure blood sugar levels and the levels of several hormones that are found in the body and are related to glucose metabolism.
|
2000-200 Study 10-day Placebo
n=13 Participants
Participants received placebo via oral unmarked capsule daily for 10 days with a wash-out period of at least 4 weeks between studies. This is a randomized, double blinded, cross-over study, so subjects who participated in the pioglitazone intervention also participated in the placebo intervention. Either placebo or pioglitazone was administered to each subject randomly for the study.
The investigators used a research procedure called a "pancreatic clamp" study to study the effects of pioglitazone. During the clamp procedure, glucose (a sugar) and insulin (a hormone that regulates the amount of glucose in the blood) are infused with an intravenous catheter, and blood samples are collected periodically throughout the procedure to measure blood sugar levels and the levels of several hormones that are found in the body and are related to glucose metabolism.
|
2000-200 Study 21-day Pioglitazone
n=16 Participants
Participants received Pioglitazone (pio) 45mg via oral unmarked capsule daily for 21 days with a wash-out period of at least 4 weeks between studies. This is a randomized, double blinded, cross-over study, so subjects who participated in the pioglitazone intervention also participated in the placebo intervention. Either placebo or pioglitazone was administered to each subject randomly for the study.
The investigators used a research procedure called a "pancreatic clamp" study to study the effects of pioglitazone. During the clamp procedure, glucose (a sugar) and insulin (a hormone that regulates the amount of glucose in the blood) are infused with an intravenous catheter, and blood samples are collected periodically throughout the procedure to measure blood sugar levels and the levels of several hormones that are found in the body and are related to glucose metabolism.
|
2000-200 Study 21-day Placebo
n=16 Participants
Participants received placebo via oral unmarked capsule daily for 21 days with a wash-out period of at least 4 weeks between studies. This is a randomized, double blinded, cross-over study, so subjects who participated in the pioglitazone intervention also participated in the placebo intervention. Either placebo or pioglitazone was administered to each subject randomly for the study.
The investigators used a research procedure called a "pancreatic clamp" study to study the effects of pioglitazone. During the clamp procedure, glucose (a sugar) and insulin (a hormone that regulates the amount of glucose in the blood) are infused with an intravenous catheter, and blood samples are collected periodically throughout the procedure to measure blood sugar levels and the levels of several hormones that are found in the body and are related to glucose metabolism.
|
|---|---|---|---|---|
|
Endogenous Glucose Production (EGP)
|
1.26 mg/kg/min
Standard Error 0.19
|
1.25 mg/kg/min
Standard Error 0.20
|
0.90 mg/kg/min
Standard Error 0.13
|
1.48 mg/kg/min
Standard Error 0.18
|
PRIMARY outcome
Timeframe: Up to 6 hoursGlucose rates of disappearance were measured using a stepped pancreatic clamp study procedure under various treatment conditions (e.g., Pioglitazone or placebo at 10-days and/or 21-days) by monitoring the level of a non-radioactive, naturally occurring form of glucose (sugar). For purposes of this study, the most relevant data for the final hour is summarized within each study Pioglitazone and Placebo study arm/group, respectively. Results are summarized by study arm/group and reported in milligrams/kilograms/minute (mg/kg/min).
Outcome measures
| Measure |
2000-200 Study 10-day Pioglitazone
n=13 Participants
Participants received Pioglitazone (pio) 45mg via oral unmarked capsule daily for 10 days with a wash-out period of at least 4 weeks between studies. This is a randomized, double blinded, cross-over study, so subjects who participated in the pioglitazone intervention also participated in the placebo intervention. Either placebo or pioglitazone was administered to each subject randomly for the study.
The investigators used a research procedure called a "pancreatic clamp" study to study the effects of pioglitazone. During the clamp procedure, glucose (a sugar) and insulin (a hormone that regulates the amount of glucose in the blood) are infused with an intravenous catheter, and blood samples are collected periodically throughout the procedure to measure blood sugar levels and the levels of several hormones that are found in the body and are related to glucose metabolism.
|
2000-200 Study 10-day Placebo
n=13 Participants
Participants received placebo via oral unmarked capsule daily for 10 days with a wash-out period of at least 4 weeks between studies. This is a randomized, double blinded, cross-over study, so subjects who participated in the pioglitazone intervention also participated in the placebo intervention. Either placebo or pioglitazone was administered to each subject randomly for the study.
The investigators used a research procedure called a "pancreatic clamp" study to study the effects of pioglitazone. During the clamp procedure, glucose (a sugar) and insulin (a hormone that regulates the amount of glucose in the blood) are infused with an intravenous catheter, and blood samples are collected periodically throughout the procedure to measure blood sugar levels and the levels of several hormones that are found in the body and are related to glucose metabolism.
|
2000-200 Study 21-day Pioglitazone
n=16 Participants
Participants received Pioglitazone (pio) 45mg via oral unmarked capsule daily for 21 days with a wash-out period of at least 4 weeks between studies. This is a randomized, double blinded, cross-over study, so subjects who participated in the pioglitazone intervention also participated in the placebo intervention. Either placebo or pioglitazone was administered to each subject randomly for the study.
The investigators used a research procedure called a "pancreatic clamp" study to study the effects of pioglitazone. During the clamp procedure, glucose (a sugar) and insulin (a hormone that regulates the amount of glucose in the blood) are infused with an intravenous catheter, and blood samples are collected periodically throughout the procedure to measure blood sugar levels and the levels of several hormones that are found in the body and are related to glucose metabolism.
|
2000-200 Study 21-day Placebo
n=16 Participants
Participants received placebo via oral unmarked capsule daily for 21 days with a wash-out period of at least 4 weeks between studies. This is a randomized, double blinded, cross-over study, so subjects who participated in the pioglitazone intervention also participated in the placebo intervention. Either placebo or pioglitazone was administered to each subject randomly for the study.
The investigators used a research procedure called a "pancreatic clamp" study to study the effects of pioglitazone. During the clamp procedure, glucose (a sugar) and insulin (a hormone that regulates the amount of glucose in the blood) are infused with an intravenous catheter, and blood samples are collected periodically throughout the procedure to measure blood sugar levels and the levels of several hormones that are found in the body and are related to glucose metabolism.
|
|---|---|---|---|---|
|
Glucose Rates of Disappearance (Rd)
|
3.9 mg/kg/min
Standard Error 0.15
|
3.6 mg/kg/min
Standard Error 0.10
|
3.90 mg/kg/min
Standard Error 0.15
|
3.60 mg/kg/min
Standard Error 0.10
|
SECONDARY outcome
Timeframe: Outcome was compared prior to and post 10-day or 21-day administration of either placebo or PioglitazoneGene expression of inflammatory markers in both whole fat tissue and isolated macrophages were studied by quantitative, real-time reverse transcriptase polymerase chain reaction (RT-PCR) in placebo and Pioglitazone groups of either 10- or 21-day study. The reporting data was calculated as the ratio between the target genes and housekeeping genes in either the 10- or 21-day study.
Outcome measures
| Measure |
2000-200 Study 10-day Pioglitazone
n=13 Participants
Participants received Pioglitazone (pio) 45mg via oral unmarked capsule daily for 10 days with a wash-out period of at least 4 weeks between studies. This is a randomized, double blinded, cross-over study, so subjects who participated in the pioglitazone intervention also participated in the placebo intervention. Either placebo or pioglitazone was administered to each subject randomly for the study.
The investigators used a research procedure called a "pancreatic clamp" study to study the effects of pioglitazone. During the clamp procedure, glucose (a sugar) and insulin (a hormone that regulates the amount of glucose in the blood) are infused with an intravenous catheter, and blood samples are collected periodically throughout the procedure to measure blood sugar levels and the levels of several hormones that are found in the body and are related to glucose metabolism.
|
2000-200 Study 10-day Placebo
n=13 Participants
Participants received placebo via oral unmarked capsule daily for 10 days with a wash-out period of at least 4 weeks between studies. This is a randomized, double blinded, cross-over study, so subjects who participated in the pioglitazone intervention also participated in the placebo intervention. Either placebo or pioglitazone was administered to each subject randomly for the study.
The investigators used a research procedure called a "pancreatic clamp" study to study the effects of pioglitazone. During the clamp procedure, glucose (a sugar) and insulin (a hormone that regulates the amount of glucose in the blood) are infused with an intravenous catheter, and blood samples are collected periodically throughout the procedure to measure blood sugar levels and the levels of several hormones that are found in the body and are related to glucose metabolism.
|
2000-200 Study 21-day Pioglitazone
n=16 Participants
Participants received Pioglitazone (pio) 45mg via oral unmarked capsule daily for 21 days with a wash-out period of at least 4 weeks between studies. This is a randomized, double blinded, cross-over study, so subjects who participated in the pioglitazone intervention also participated in the placebo intervention. Either placebo or pioglitazone was administered to each subject randomly for the study.
The investigators used a research procedure called a "pancreatic clamp" study to study the effects of pioglitazone. During the clamp procedure, glucose (a sugar) and insulin (a hormone that regulates the amount of glucose in the blood) are infused with an intravenous catheter, and blood samples are collected periodically throughout the procedure to measure blood sugar levels and the levels of several hormones that are found in the body and are related to glucose metabolism.
|
2000-200 Study 21-day Placebo
n=16 Participants
Participants received placebo via oral unmarked capsule daily for 21 days with a wash-out period of at least 4 weeks between studies. This is a randomized, double blinded, cross-over study, so subjects who participated in the pioglitazone intervention also participated in the placebo intervention. Either placebo or pioglitazone was administered to each subject randomly for the study.
The investigators used a research procedure called a "pancreatic clamp" study to study the effects of pioglitazone. During the clamp procedure, glucose (a sugar) and insulin (a hormone that regulates the amount of glucose in the blood) are infused with an intravenous catheter, and blood samples are collected periodically throughout the procedure to measure blood sugar levels and the levels of several hormones that are found in the body and are related to glucose metabolism.
|
|---|---|---|---|---|
|
Gene Expression in Both Whole Fat Tissue and Isolated Macrophages
Whole adipose tissue FOXP3
|
0.0005 ratio
Standard Error 0.0001
|
0.0006 ratio
Standard Error 0.0001
|
0.0035 ratio
Standard Error 0.0010
|
0.0045 ratio
Standard Error 0.0013
|
|
Gene Expression in Both Whole Fat Tissue and Isolated Macrophages
Whole adipose tissue CD25
|
0.89 ratio
Standard Error 0.04
|
0.90 ratio
Standard Error 0.05
|
0.0035 ratio
Standard Error 0.0008
|
0.0045 ratio
Standard Error 0.0013
|
|
Gene Expression in Both Whole Fat Tissue and Isolated Macrophages
Adipose tissue macrophage MCP-1
|
0.80 ratio
Standard Error 0.60
|
1.90 ratio
Standard Error 0.50
|
0.07 ratio
Standard Error 0.01
|
0.11 ratio
Standard Error 0.02
|
|
Gene Expression in Both Whole Fat Tissue and Isolated Macrophages
Adipose tissue macrophage CCR2
|
0.009 ratio
Standard Error 0.001
|
0.023 ratio
Standard Error 0.007
|
0.0020 ratio
Standard Error 0.0005
|
0.0040 ratio
Standard Error 0.0005
|
|
Gene Expression in Both Whole Fat Tissue and Isolated Macrophages
Adipose tissue hyaluronan synthase expression
|
0.007 ratio
Standard Error 0.001
|
0.015 ratio
Standard Error 0.002
|
0.013 ratio
Standard Error 0.007
|
0.019 ratio
Standard Error 0.006
|
|
Gene Expression in Both Whole Fat Tissue and Isolated Macrophages
Adipose tissue hyaluronan receptor CD44 expression
|
0.150 ratio
Standard Error 0.075
|
0.225 ratio
Standard Error 0.025
|
0.050 ratio
Standard Error 0.01
|
0.10 ratio
Standard Error 0.01
|
|
Gene Expression in Both Whole Fat Tissue and Isolated Macrophages
Macrophage CD14 expression
|
0.79 ratio
Standard Error 0.01
|
0.84 ratio
Standard Error 0.02
|
0.07 ratio
Standard Error 0.01
|
0.11 ratio
Standard Error 0.02
|
|
Gene Expression in Both Whole Fat Tissue and Isolated Macrophages
Macrophage CD68 expression
|
0.23 ratio
Standard Error 0.07
|
0.26 ratio
Standard Error 0.02
|
0.20 ratio
Standard Error 0.05
|
0.40 ratio
Standard Error 0.1
|
|
Gene Expression in Both Whole Fat Tissue and Isolated Macrophages
Whole adipose tissue DEC205
|
0.0009 ratio
Standard Error 0.0002
|
0.0016 ratio
Standard Error 0.02
|
0.0015 ratio
Standard Error 0.0004
|
0.0024 ratio
Standard Error 0.0003
|
|
Gene Expression in Both Whole Fat Tissue and Isolated Macrophages
Whole adipose tissue DC SIGN
|
0.0007 ratio
Standard Error 0.0002
|
0.001 ratio
Standard Error 0.0001
|
0.005 ratio
Standard Error 0.0020
|
0.0125 ratio
Standard Error 0.0040
|
|
Gene Expression in Both Whole Fat Tissue and Isolated Macrophages
Whole adipose tissue MPO-3
|
0.018 ratio
Standard Error 0.009
|
0.031 ratio
Standard Error 0.012
|
0.009 ratio
Standard Error 0.002
|
0.02 ratio
Standard Error 0.004
|
SECONDARY outcome
Timeframe: Assessed at day 1 prior to the intervention and on day 10 or 21 following the intervention, day 10 or 21 following the intervention reportedPopulation: Day 1 macrophage data was not collected and reported.
Adipose tissue biopsy was performed on day one or on the last day (10th or 21st day) for the corresponding Pioglitazone and placebo interventions. Macrophages were stained with immunofluorescence antibody after isolation from adipose tissue and processed. The percentage of macrophage content in stromal vascular fraction cells (SVF) analyzed by Fluorescence-activated cell sorter analysis (FACS) was determined. Results are summarized by study arm/group and reported in milligrams/kilograms/minute (mg/kg/min).
Outcome measures
| Measure |
2000-200 Study 10-day Pioglitazone
n=13 Participants
Participants received Pioglitazone (pio) 45mg via oral unmarked capsule daily for 10 days with a wash-out period of at least 4 weeks between studies. This is a randomized, double blinded, cross-over study, so subjects who participated in the pioglitazone intervention also participated in the placebo intervention. Either placebo or pioglitazone was administered to each subject randomly for the study.
The investigators used a research procedure called a "pancreatic clamp" study to study the effects of pioglitazone. During the clamp procedure, glucose (a sugar) and insulin (a hormone that regulates the amount of glucose in the blood) are infused with an intravenous catheter, and blood samples are collected periodically throughout the procedure to measure blood sugar levels and the levels of several hormones that are found in the body and are related to glucose metabolism.
|
2000-200 Study 10-day Placebo
n=13 Participants
Participants received placebo via oral unmarked capsule daily for 10 days with a wash-out period of at least 4 weeks between studies. This is a randomized, double blinded, cross-over study, so subjects who participated in the pioglitazone intervention also participated in the placebo intervention. Either placebo or pioglitazone was administered to each subject randomly for the study.
The investigators used a research procedure called a "pancreatic clamp" study to study the effects of pioglitazone. During the clamp procedure, glucose (a sugar) and insulin (a hormone that regulates the amount of glucose in the blood) are infused with an intravenous catheter, and blood samples are collected periodically throughout the procedure to measure blood sugar levels and the levels of several hormones that are found in the body and are related to glucose metabolism.
|
2000-200 Study 21-day Pioglitazone
n=16 Participants
Participants received Pioglitazone (pio) 45mg via oral unmarked capsule daily for 21 days with a wash-out period of at least 4 weeks between studies. This is a randomized, double blinded, cross-over study, so subjects who participated in the pioglitazone intervention also participated in the placebo intervention. Either placebo or pioglitazone was administered to each subject randomly for the study.
The investigators used a research procedure called a "pancreatic clamp" study to study the effects of pioglitazone. During the clamp procedure, glucose (a sugar) and insulin (a hormone that regulates the amount of glucose in the blood) are infused with an intravenous catheter, and blood samples are collected periodically throughout the procedure to measure blood sugar levels and the levels of several hormones that are found in the body and are related to glucose metabolism.
|
2000-200 Study 21-day Placebo
n=16 Participants
Participants received placebo via oral unmarked capsule daily for 21 days with a wash-out period of at least 4 weeks between studies. This is a randomized, double blinded, cross-over study, so subjects who participated in the pioglitazone intervention also participated in the placebo intervention. Either placebo or pioglitazone was administered to each subject randomly for the study.
The investigators used a research procedure called a "pancreatic clamp" study to study the effects of pioglitazone. During the clamp procedure, glucose (a sugar) and insulin (a hormone that regulates the amount of glucose in the blood) are infused with an intravenous catheter, and blood samples are collected periodically throughout the procedure to measure blood sugar levels and the levels of several hormones that are found in the body and are related to glucose metabolism.
|
|---|---|---|---|---|
|
Effects of Pioglitazone on Adipose Tissue Percentage of Macrophage Content
|
10.20 percentage of macrophage content
Standard Error 1.6
|
12.00 percentage of macrophage content
Standard Error 1.9
|
4.20 percentage of macrophage content
Standard Error 2.80
|
13.50 percentage of macrophage content
Standard Error 1.50
|
SECONDARY outcome
Timeframe: Outcome was compared between Pioglitazone and placebo group prior to and after 21-day administrationPopulation: Due to the unsuccessful IHF assay macrophage % content data was not collected for the 10-day study.
Adipose tissue percentage of macrophage content was analyzed by Immuno-fluorescence staining (iNOS+ and CD68+). Both the immuno-fluorescence stained macrophages and all other stained cells will be counted after staining. The percentage of macrophage content will be calculated as the the ratio between the number of macrophage and all other cells.
Outcome measures
| Measure |
2000-200 Study 10-day Pioglitazone
n=16 Participants
Participants received Pioglitazone (pio) 45mg via oral unmarked capsule daily for 10 days with a wash-out period of at least 4 weeks between studies. This is a randomized, double blinded, cross-over study, so subjects who participated in the pioglitazone intervention also participated in the placebo intervention. Either placebo or pioglitazone was administered to each subject randomly for the study.
The investigators used a research procedure called a "pancreatic clamp" study to study the effects of pioglitazone. During the clamp procedure, glucose (a sugar) and insulin (a hormone that regulates the amount of glucose in the blood) are infused with an intravenous catheter, and blood samples are collected periodically throughout the procedure to measure blood sugar levels and the levels of several hormones that are found in the body and are related to glucose metabolism.
|
2000-200 Study 10-day Placebo
n=16 Participants
Participants received placebo via oral unmarked capsule daily for 10 days with a wash-out period of at least 4 weeks between studies. This is a randomized, double blinded, cross-over study, so subjects who participated in the pioglitazone intervention also participated in the placebo intervention. Either placebo or pioglitazone was administered to each subject randomly for the study.
The investigators used a research procedure called a "pancreatic clamp" study to study the effects of pioglitazone. During the clamp procedure, glucose (a sugar) and insulin (a hormone that regulates the amount of glucose in the blood) are infused with an intravenous catheter, and blood samples are collected periodically throughout the procedure to measure blood sugar levels and the levels of several hormones that are found in the body and are related to glucose metabolism.
|
2000-200 Study 21-day Pioglitazone
Participants received Pioglitazone (pio) 45mg via oral unmarked capsule daily for 21 days with a wash-out period of at least 4 weeks between studies. This is a randomized, double blinded, cross-over study, so subjects who participated in the pioglitazone intervention also participated in the placebo intervention. Either placebo or pioglitazone was administered to each subject randomly for the study.
The investigators used a research procedure called a "pancreatic clamp" study to study the effects of pioglitazone. During the clamp procedure, glucose (a sugar) and insulin (a hormone that regulates the amount of glucose in the blood) are infused with an intravenous catheter, and blood samples are collected periodically throughout the procedure to measure blood sugar levels and the levels of several hormones that are found in the body and are related to glucose metabolism.
|
2000-200 Study 21-day Placebo
Participants received placebo via oral unmarked capsule daily for 21 days with a wash-out period of at least 4 weeks between studies. This is a randomized, double blinded, cross-over study, so subjects who participated in the pioglitazone intervention also participated in the placebo intervention. Either placebo or pioglitazone was administered to each subject randomly for the study.
The investigators used a research procedure called a "pancreatic clamp" study to study the effects of pioglitazone. During the clamp procedure, glucose (a sugar) and insulin (a hormone that regulates the amount of glucose in the blood) are infused with an intravenous catheter, and blood samples are collected periodically throughout the procedure to measure blood sugar levels and the levels of several hormones that are found in the body and are related to glucose metabolism.
|
|---|---|---|---|---|
|
Adipose Tissue Percentage of Macrophage Content
|
18 percentage of macrophage content
Standard Error 7
|
43 percentage of macrophage content
Standard Error 15
|
—
|
—
|
SECONDARY outcome
Timeframe: Outcome was compared between Pioglitazone and placebo group prior to and after 21-day administrationPopulation: Due to the unsuccessful IHC assay, T lymphocyte % content was unable to be collected for the 10-day study.
Adipose tissue T lymphocyte content (%) was analyzed by Immunohistochemistry (IHC) staining with Treg-specific marker FOXP3 Both the IHC FOXP3 stained T lymphocyte and all other stained cells will be counted after staining. The percentage of T lymphocyte content will be calculated as the the ratio between the number of T lymphocyte and all other cells.
Outcome measures
| Measure |
2000-200 Study 10-day Pioglitazone
n=16 Participants
Participants received Pioglitazone (pio) 45mg via oral unmarked capsule daily for 10 days with a wash-out period of at least 4 weeks between studies. This is a randomized, double blinded, cross-over study, so subjects who participated in the pioglitazone intervention also participated in the placebo intervention. Either placebo or pioglitazone was administered to each subject randomly for the study.
The investigators used a research procedure called a "pancreatic clamp" study to study the effects of pioglitazone. During the clamp procedure, glucose (a sugar) and insulin (a hormone that regulates the amount of glucose in the blood) are infused with an intravenous catheter, and blood samples are collected periodically throughout the procedure to measure blood sugar levels and the levels of several hormones that are found in the body and are related to glucose metabolism.
|
2000-200 Study 10-day Placebo
n=16 Participants
Participants received placebo via oral unmarked capsule daily for 10 days with a wash-out period of at least 4 weeks between studies. This is a randomized, double blinded, cross-over study, so subjects who participated in the pioglitazone intervention also participated in the placebo intervention. Either placebo or pioglitazone was administered to each subject randomly for the study.
The investigators used a research procedure called a "pancreatic clamp" study to study the effects of pioglitazone. During the clamp procedure, glucose (a sugar) and insulin (a hormone that regulates the amount of glucose in the blood) are infused with an intravenous catheter, and blood samples are collected periodically throughout the procedure to measure blood sugar levels and the levels of several hormones that are found in the body and are related to glucose metabolism.
|
2000-200 Study 21-day Pioglitazone
Participants received Pioglitazone (pio) 45mg via oral unmarked capsule daily for 21 days with a wash-out period of at least 4 weeks between studies. This is a randomized, double blinded, cross-over study, so subjects who participated in the pioglitazone intervention also participated in the placebo intervention. Either placebo or pioglitazone was administered to each subject randomly for the study.
The investigators used a research procedure called a "pancreatic clamp" study to study the effects of pioglitazone. During the clamp procedure, glucose (a sugar) and insulin (a hormone that regulates the amount of glucose in the blood) are infused with an intravenous catheter, and blood samples are collected periodically throughout the procedure to measure blood sugar levels and the levels of several hormones that are found in the body and are related to glucose metabolism.
|
2000-200 Study 21-day Placebo
Participants received placebo via oral unmarked capsule daily for 21 days with a wash-out period of at least 4 weeks between studies. This is a randomized, double blinded, cross-over study, so subjects who participated in the pioglitazone intervention also participated in the placebo intervention. Either placebo or pioglitazone was administered to each subject randomly for the study.
The investigators used a research procedure called a "pancreatic clamp" study to study the effects of pioglitazone. During the clamp procedure, glucose (a sugar) and insulin (a hormone that regulates the amount of glucose in the blood) are infused with an intravenous catheter, and blood samples are collected periodically throughout the procedure to measure blood sugar levels and the levels of several hormones that are found in the body and are related to glucose metabolism.
|
|---|---|---|---|---|
|
Adipose Tissue Regulatory T Lymphocyte Content
|
14 percentage of T lymphocyte content
Standard Error 3
|
17 percentage of T lymphocyte content
Standard Error 5
|
—
|
—
|
Adverse Events
2000-200 Study 10-day Pioglitazone
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
2000-200 Study 10-day Placebo
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
2000-200 Study 21-day Pioglitazone
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
2000-200 Study 21-day Placebo
Serious events: 0 serious events
Other events: 1 other events
Deaths: 1 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
2000-200 Study 10-day Pioglitazone
n=13 participants at risk
Participants received Pioglitazone (pio) 45mg via oral unmarked capsule daily for 10 days with a wash-out period of at least 4 weeks between studies. This is a randomized, double blinded, cross-over study, so subjects who participated in the pioglitazone intervention also participated in the placebo intervention. Either placebo or pioglitazone was administered to each subject randomly for the study.
The investigators used a research procedure called a "pancreatic clamp" study to study the effects of pioglitazone. During the clamp procedure, glucose (a sugar) and insulin (a hormone that regulates the amount of glucose in the blood) are infused with an intravenous catheter, and blood samples are collected periodically throughout the procedure to measure blood sugar levels and the levels of several hormones that are found in the body and are related to glucose metabolism.
|
2000-200 Study 10-day Placebo
n=13 participants at risk
Participants received placebo via oral unmarked capsule daily for 10 days with a wash-out period of at least 4 weeks between studies. This is a randomized, double blinded, cross-over study, so subjects who participated in the pioglitazone intervention also participated in the placebo intervention. Either placebo or pioglitazone was administered to each subject randomly for the study.
The investigators used a research procedure called a "pancreatic clamp" study to study the effects of pioglitazone. During the clamp procedure, glucose (a sugar) and insulin (a hormone that regulates the amount of glucose in the blood) are infused with an intravenous catheter, and blood samples are collected periodically throughout the procedure to measure blood sugar levels and the levels of several hormones that are found in the body and are related to glucose metabolism.
|
2000-200 Study 21-day Pioglitazone
n=16 participants at risk
Participants received Pioglitazone (pio) 45mg via oral unmarked capsule daily for 21 days with a wash-out period of at least 4 weeks between studies. This is a randomized, double blinded, cross-over study, so subjects who participated in the pioglitazone intervention also participated in the placebo intervention. Either placebo or pioglitazone was administered to each subject randomly for the study.
The investigators used a research procedure called a "pancreatic clamp" study to study the effects of pioglitazone. During the clamp procedure, glucose (a sugar) and insulin (a hormone that regulates the amount of glucose in the blood) are infused with an intravenous catheter, and blood samples are collected periodically throughout the procedure to measure blood sugar levels and the levels of several hormones that are found in the body and are related to glucose metabolism.
|
2000-200 Study 21-day Placebo
n=16 participants at risk
Participants received placebo via oral unmarked capsule daily for 21 days with a wash-out period of at least 4 weeks between studies. This is a randomized, double blinded, cross-over study, so subjects who participated in the pioglitazone intervention also participated in the placebo intervention. Either placebo or pioglitazone was administered to each subject randomly for the study.
The investigators used a research procedure called a "pancreatic clamp" study to study the effects of pioglitazone. During the clamp procedure, glucose (a sugar) and insulin (a hormone that regulates the amount of glucose in the blood) are infused with an intravenous catheter, and blood samples are collected periodically throughout the procedure to measure blood sugar levels and the levels of several hormones that are found in the body and are related to glucose metabolism.
|
|---|---|---|---|---|
|
Metabolism and nutrition disorders
Hypotensive Episode
|
0.00%
0/13 • Up to 10 days for participants in 10-day treatment and 21 days for participants in 21-day treatment.
|
0.00%
0/13 • Up to 10 days for participants in 10-day treatment and 21 days for participants in 21-day treatment.
|
0.00%
0/16 • Up to 10 days for participants in 10-day treatment and 21 days for participants in 21-day treatment.
|
6.2%
1/16 • Number of events 1 • Up to 10 days for participants in 10-day treatment and 21 days for participants in 21-day treatment.
|
Additional Information
Prof. Meredith A. Hawkins
Albert Einstein College of Medicine
Phone: 718 430 3186
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place