Trial Outcomes & Findings for Mechanism Underlying Beta-cell Failure in Obese African Americans With History of Hyperglycemic Crises (NCT NCT00753142)
NCT ID: NCT00753142
Last Updated: 2018-10-12
Results Overview
An arginine stimulation test was used to evaluate beta-cell function and insulin secretion. Increased glucose in the blood causes insulin to be released, beginning with a spike in insulin in the first 10 minutes and plateauing 2 to 3 later. Diminished first-phase insulin release is an early indicator of beta-cell dysfunction. Two sequential arginine stimulation tests were performed, the first set before and the second after completion of the 20-hour dextrose infusion. The first-phase insulin release (FPIR) was calculated as the sum of the insulin levels at 2, 3, 4, and 5 minutes after the arginine infusion. FPIR is expected to rise after the dextrose (glucose) infusion and FPIR generally rises less in persons with impaired glucose tolerance.
COMPLETED
NA
28 participants
Hour 0, Hour 20
2018-10-12
Participant Flow
Participant enrollment began in March 2004 and all study follow-up was completed in December 2009. The study was conducted at the Clinical Research Center at Grady Memorial Hospital in Atlanta, Georgia.
Participant milestones
| Measure |
Ketosis-prone Diabetics
Obese African Americans with type 2 diabetes and a history of diabetic ketoacidosis (DKA) receiving a 48-hour infusion of Intralipid 20% at 40 mL/hour and a glucose infusion of 10% dextrose infused at a rate of 200 mg/m\^2/min for 20 hours.
|
Ketosis-resistant Diabetics
Obese African Americans with type 2 diabetes with hyperglycemia without ketosis receiving a 48-hour infusion of Intralipid 20% at 40 mL/hour and a glucose infusion of 10% dextrose infused at a rate of 200 mg/m\^2/min for 20 hours.
|
Non-diabetic Control Group
Obese African Americans without diabetes receiving a glucose infusion of 10% dextrose infused at a rate of 200 mg/m\^2/min for 20 hours.
|
|---|---|---|---|
|
Overall Study
STARTED
|
8
|
7
|
13
|
|
Overall Study
COMPLETED
|
8
|
7
|
13
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Mechanism Underlying Beta-cell Failure in Obese African Americans With History of Hyperglycemic Crises
Baseline characteristics by cohort
| Measure |
Ketosis-prone Diabetics
n=8 Participants
Obese African Americans with type 2 diabetes and a history of diabetic ketoacidosis (DKA) receiving a 48-hour infusion of Intralipid 20% at 40 mL/hour and a glucose infusion of 10% dextrose infused at a rate of 200 mg/m\^2/min for 20 hours.
|
Ketosis-resistant Diabetics
n=7 Participants
Obese African Americans with type 2 diabetes with hyperglycemia without ketosis receiving a 48-hour infusion of Intralipid 20% at 40 mL/hour and a glucose infusion of 10% dextrose infused at a rate of 200 mg/m\^2/min for 20 hours.
|
Non-diabetic Control Group
n=13 Participants
Obese African Americans without diabetes receiving a glucose infusion of 10% dextrose infused at a rate of 200 mg/m\^2/min for 20 hours.
|
Total
n=28 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
42.8 years
STANDARD_DEVIATION 10.6 • n=5 Participants
|
49.7 years
STANDARD_DEVIATION 8.1 • n=7 Participants
|
40 years
STANDARD_DEVIATION 9.3 • n=5 Participants
|
44 years
STANDARD_DEVIATION 9 • n=4 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
16 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
12 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
8 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
28 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
8 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
28 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Hour 0, Hour 20An arginine stimulation test was used to evaluate beta-cell function and insulin secretion. Increased glucose in the blood causes insulin to be released, beginning with a spike in insulin in the first 10 minutes and plateauing 2 to 3 later. Diminished first-phase insulin release is an early indicator of beta-cell dysfunction. Two sequential arginine stimulation tests were performed, the first set before and the second after completion of the 20-hour dextrose infusion. The first-phase insulin release (FPIR) was calculated as the sum of the insulin levels at 2, 3, 4, and 5 minutes after the arginine infusion. FPIR is expected to rise after the dextrose (glucose) infusion and FPIR generally rises less in persons with impaired glucose tolerance.
Outcome measures
| Measure |
Ketosis-prone Diabetics
n=8 Participants
Obese African Americans with type 2 diabetes and a history of diabetic ketoacidosis (DKA) receiving a 48-hour infusion of Intralipid 20% at 40 mL/hour and a glucose infusion of 10% dextrose infused at a rate of 200 mg/m\^2/min for 20 hours.
|
Ketosis-resistant Diabetics
n=7 Participants
Obese African Americans with type 2 diabetes with hyperglycemia without ketosis receiving a 48-hour infusion of Intralipid 20% at 40 mL/hour and a glucose infusion of 10% dextrose infused at a rate of 200 mg/m\^2/min for 20 hours.
|
Non-diabetic Control Group
n=13 Participants
Obese African Americans without diabetes receiving a glucose infusion of 10% dextrose infused at a rate of 200 mg/m\^2/min for 20 hours.
|
|---|---|---|---|
|
First-Phase Insulin Release (FPIR)
Before glucose infusion
|
264 microunits/ml
Standard Deviation 80
|
339 microunits/ml
Standard Deviation 221
|
197 microunits/ml
Standard Deviation 33
|
|
First-Phase Insulin Release (FPIR)
After glucose infusion
|
359 microunits/ml
Standard Deviation 42
|
381 microunits/ml
Standard Deviation 147
|
299 microunits/ml
Standard Deviation 30
|
SECONDARY outcome
Timeframe: Hour 20Pancreatic beta-cells can adapt to insulin resistance during the early stages of diabetes but continuous exposure of beta-cells to prolonged hyperglycemia can cause irreversible damage due to glucotoxicity. This study aimed to evaluate whether hyperglycemia-induced reduced beta-cell failure was the result of beta-cell exhaustion or beta-cell desensitization, however, no participants experienced beta-cell failure so this original analysis could not be performed.
Outcome measures
| Measure |
Ketosis-prone Diabetics
n=8 Participants
Obese African Americans with type 2 diabetes and a history of diabetic ketoacidosis (DKA) receiving a 48-hour infusion of Intralipid 20% at 40 mL/hour and a glucose infusion of 10% dextrose infused at a rate of 200 mg/m\^2/min for 20 hours.
|
Ketosis-resistant Diabetics
n=7 Participants
Obese African Americans with type 2 diabetes with hyperglycemia without ketosis receiving a 48-hour infusion of Intralipid 20% at 40 mL/hour and a glucose infusion of 10% dextrose infused at a rate of 200 mg/m\^2/min for 20 hours.
|
Non-diabetic Control Group
n=13 Participants
Obese African Americans without diabetes receiving a glucose infusion of 10% dextrose infused at a rate of 200 mg/m\^2/min for 20 hours.
|
|---|---|---|---|
|
Number of Participants With Beta-cell Failure
|
0 Participants
|
0 Participants
|
0 Participants
|
Adverse Events
Ketosis-prone Diabetics
Ketosis-resistant Diabetics
Non-diabetic Control Group
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Ketosis-prone Diabetics
n=8 participants at risk
Obese African Americans with type 2 diabetes and a history of diabetic ketoacidosis (DKA) receiving a 48-hour infusion of Intralipid 20% at 40 mL/hour and a glucose infusion of 10% dextrose infused at a rate of 200 mg/m\^2/min for 20 hours.
|
Ketosis-resistant Diabetics
n=7 participants at risk
Obese African Americans with type 2 diabetes with hyperglycemia without ketosis receiving a 48-hour infusion of Intralipid 20% at 40 mL/hour and a glucose infusion of 10% dextrose infused at a rate of 200 mg/m\^2/min for 20 hours.
|
Non-diabetic Control Group
n=13 participants at risk
Obese African Americans without diabetes receiving a glucose infusion of 10% dextrose infused at a rate of 200 mg/m\^2/min for 20 hours.
|
|---|---|---|---|
|
Endocrine disorders
hyperglycemia
|
12.5%
1/8
|
14.3%
1/7
|
0.00%
0/13
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place