Phase 4
N=70
Mechanisms Underlying Metabolic Syndrome in Obesity
Metabolic Syndrome · Insulin Resistance · Prediabetes
Bottom Line
View on ClinicalTrials.gov: NCT00579813 ↗Enrolled (actual)
70
Serious AEs
0.0%
Results posted
Jul 2011
Primary outcome: Primary: Change in Insulin Sensitivity Using FSIGT — 1.7; 2.4; 7.02 FSIGT units (x10^-4/min/uU/ml)
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Pioglitazone (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Philip Kern
- Primary completion
- Jan 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Insulin Sensitivity Using FSIGT |
1.7; 2.4; 7.02 | — |
| PRIMARY Effects of Pioglitazone on Changes in BMI |
32.4; 33.4; 22.6 | — |
| PRIMARY Changes in Muscle Lipid After Pioglitazone |
7.0; 4.6; 2.7 | — |
| PRIMARY Changes in Fat Inflammation Following Pioglitazone |
27; 19; 17 | — |
Summary
The purpose of this study is to better understand the link between obesity and diabetes or pre-diabetes.
Eligibility Criteria
Inclusion Criteria
- 18-65 years of age
- BMI 28+
- diabetes, impaired glucose tolerance or normal glucose tolerance
Exclusion Criteria
- AST >2x normal
- congestive heart failure
- history of coronary artery disease
- chronic renal insufficiency (creatinine > 1.4mg/dl)
- use of gemfibrozil, ACE inhibitors, and angiotensin receptor II blockers, or anticoagulants
Data sourced from ClinicalTrials.gov (NCT00579813). 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.