Phase 4
N=26
The Role of Acute Combined PPAR Alpha and Gamma Stimulation on Insulin Action in Humans
Type 2 Diabetes Mellitus
Bottom Line
View on ClinicalTrials.gov: NCT00179400 ↗Enrolled (actual)
26
Serious AEs
0.0%
Results posted
Mar 2025
Primary outcome: Primary: Endogenous Glucose Production (EGP) — 1.26; 1.25; 0.90; 1.48 mg/kg/min
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Pioglitazone (Drug); Placebo (Drug); Pancreatic Clamp Study (Procedure)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Albert Einstein College of Medicine
- Primary completion
- Jul 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Endogenous Glucose Production (EGP) |
1.26; 1.25; 0.90; 1.48 | — |
| PRIMARY Glucose Rates of Disappearance (Rd) |
3.9; 3.6; 3.90; 3.60 | — |
| SECONDARY Gene Expression in Both Whole Fat Tissue and Isolated Macrophages |
0.80; 1.90; 0.07; 0.11; 0.009; 0.023 | — |
| SECONDARY Effects of Pioglitazone on Adipose Tissue Percentage of Macrophage Content |
10.20; 12.00; 4.20; 13.50 | — |
| SECONDARY Adipose Tissue Percentage of Macrophage Content |
18; 43 | — |
| SECONDARY Adipose Tissue Regulatory T Lymphocyte Content |
14; 17 | — |
Summary
The purpose of this study is to investigate the acute effects of the thiazolidinedione agent pioglitazone (which has combined PPAR alpha and gamma stimulation) on insulin's ability to suppress glucose production, stimulated glucose uptake, and impact a number of other metabolically important endpoints, including production of adiponectin (a protein hormone which regulates sugar levels and fatty acid breakdown) in subjects with type 2 diabetes.
Eligibility Criteria
Inclusion Criteria
- Individuals with Type 2 Diabetes
Exclusion Criteria
- Individuals with bleeding disorders including gastrointestinal reflux disease (GERD), peptic ulcer disease (PUD), any gastrointestinal (GI) bleeding
- High blood pressure
- History of Coronary Artery Disease or chest pain on exertion
Data sourced from ClinicalTrials.gov (NCT00179400). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.