Trial Outcomes & Findings for Mechanisms Underlying Metabolic Syndrome in Obesity (NCT NCT00579813)

NCT ID: NCT00579813

Last Updated: 2017-06-15

Results Overview

The frequently sampled intravenous glucose tolerance test (FSIGT) involves the injection of IV glucose and the frequent measurement of glucose and insulin.

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 70 participants
• Primary outcome timeframe: Baseline and 10 weeks
• Results posted on: 2017-06-15

Participant Flow

Participant milestones

Measure	Lean Subjects Arm 1 was normal subjects on which baseline studies were performed to determine insulin sensitivity, intramyocellular lipid and resting metabolic rate.	Obese Subjects Baseline studies (Oral glucose tolerance test, Dual energy x-ray absorbiometry, Resting metabolic rate, Frequently sampled intravenous glucose tolerance test, biopsies), then 10 weeks treatment on Pioglitazone. Baseline tests are repeated at the end of medication treatment.
Overall Study STARTED	60	10
Overall Study COMPLETED	60	10
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Mechanisms Underlying Metabolic Syndrome in Obesity

Baseline characteristics by cohort

Measure	Lean Subjects n=60 Participants Arm 1 was normal subjects on which baseline studies were performed to determine insulin sensitivity, intramyocellular lipid and resting metabolic rate.	Obese Subjects n=10 Participants Baseline studies (Oral glucose tolerance test, Dual energy x-ray absorbiometry, Resting metabolic rate, Frequently sampled intravenous glucose tolerance test, biopsies), then 10 weeks treatment on Pioglitazone. Baseline tests are repeated at the end of medication treatment.	Total n=70 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Age, Categorical Between 18 and 65 years	60 Participants n=93 Participants	10 Participants n=4 Participants	70 Participants n=27 Participants
Age, Categorical >=65 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Age, Continuous	53 years STANDARD_DEVIATION 6 • n=93 Participants	57 years STANDARD_DEVIATION 2 • n=4 Participants	55 years STANDARD_DEVIATION 5 • n=27 Participants
Sex: Female, Male Female	45 Participants n=93 Participants	7 Participants n=4 Participants	52 Participants n=27 Participants
Sex: Female, Male Male	15 Participants n=93 Participants	3 Participants n=4 Participants	18 Participants n=27 Participants
Region of Enrollment United States	60 participants n=93 Participants	10 participants n=4 Participants	70 participants n=27 Participants

PRIMARY outcome

Timeframe: Baseline and 10 weeks

The frequently sampled intravenous glucose tolerance test (FSIGT) involves the injection of IV glucose and the frequent measurement of glucose and insulin.

Outcome measures

Measure	Obese Subjects, Baseline n=10 Participants Baseline studies, obese	After Pioiglitazone n=10 Participants 10 weeks of treatment	Lean Subjects, Baseline n=60 Participants lean subjects, baseline
Change in Insulin Sensitivity Using FSIGT	1.7 FSIGT units (x10^-4/min/uU/ml) Standard Deviation 0.53	2.4 FSIGT units (x10^-4/min/uU/ml) Standard Deviation 1.01	7.02 FSIGT units (x10^-4/min/uU/ml) Standard Deviation 3.7

PRIMARY outcome

Timeframe: Baseline and 10 weeks

Body Mass Index (BMI) is measured at baseline, in lean and obese subjects, and after pioglitazone in obese subjects

Outcome measures

Measure	Obese Subjects, Baseline n=10 Participants Baseline studies, obese	After Pioiglitazone n=10 Participants 10 weeks of treatment	Lean Subjects, Baseline n=60 Participants lean subjects, baseline
Effects of Pioglitazone on Changes in BMI	32.4 kg/m2 Standard Deviation 3.89	33.4 kg/m2 Standard Deviation 4.36	22.6 kg/m2 Standard Deviation 1.9

PRIMARY outcome

Timeframe: At baseline and 10 weeks

Muscle lipid following biopsy using oil red-O staining.

Outcome measures

Measure	Obese Subjects, Baseline n=10 Participants Baseline studies, obese	After Pioiglitazone n=10 Participants 10 weeks of treatment	Lean Subjects, Baseline n=60 Participants lean subjects, baseline
Changes in Muscle Lipid After Pioglitazone	7.0 arbitrary units of oil red O staining Standard Deviation 5.9	4.6 arbitrary units of oil red O staining Standard Deviation 5.9	2.7 arbitrary units of oil red O staining Standard Deviation 0.84

PRIMARY outcome

Timeframe: Baseline and 10 weeks

macrophages in fat at baseline, in lean and obese participants, and obese after pioglitazone (in obese)

Outcome measures

Measure	Obese Subjects, Baseline n=10 Participants Baseline studies, obese	After Pioiglitazone n=10 Participants 10 weeks of treatment	Lean Subjects, Baseline n=60 Participants lean subjects, baseline
Changes in Fat Inflammation Following Pioglitazone	27 macrophages per mm2 by CD68 staining Standard Deviation 6.3	19 macrophages per mm2 by CD68 staining Standard Deviation 9.5	17 macrophages per mm2 by CD68 staining Standard Deviation 6.2

Adverse Events

Lean Subjects

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Obese Subjects

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Robert E. McGehee Jr., Ph.D.

University of Arkansas for Medical Sciences

Phone: 501-603-1998

Email: rem@uams.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place