Phase 2
N=35
Effect of Rosiglitazone on the Vascular Biology of Human Fat Tissue
Metabolic Syndrome · Insulin Resistance
Bottom Line
View on ClinicalTrials.gov: NCT01150981 ↗Enrolled (actual)
35
Serious AEs
0.0%
Results posted
Mar 2012
Primary outcome: Primary: Adipose Tissue Capillary Sprout Formation — 143.5; 122.1 number of capillary sprouts
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Rosiglitazone (Drug); Placebo (Drug)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Massachusetts, Worcester
- Primary completion
- Apr 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Adipose Tissue Capillary Sprout Formation |
143.5; 122.1 | — |
| SECONDARY Serum Adiponectin |
28.56; 14.64 | — |
Summary
Insulin resistance is a common condition that can lead to type 2 diabetes. One of the commonly prescribed diabetes medications, called rosiglitazone, works by decreasing insulin resistance. Rosiglitazone appears to work on fat cells. Animal studies suggest that rosiglitazone may work by increasing blood vessel growth in fat cells. The purpose of this research is to see if rosiglitazone also increases blood vessel growth in human fat cells. The investigators will compare results from before and after being on rosiglitazone for 6 weeks.
Eligibility Criteria
Inclusion Criteria
- Overweight but otherwise in good general health.
- Age 18 - 55 years.
- Normal glucose tolerance.
- Stable weight with BMI (27-44).
- Stable medication use for the preceding month.
- BP < 150/90.
- Negative pregnancy test (*HCG), if female and of childbearing potential.
- Practicing, and willing to continue to practice appropriate contraception throughout the study if a female of childbearing potential.
Exclusion Criteria
- Serious medical illness.
- Pregnancy.
- Tobacco use within the past 6 months.
- Prior or current treatment with a thiazolidinedione.
- Patients who have received an investigational drug in the past 30 days.
- Use of systemic corticosteroids.
- Known or suspected allergy to Rosiglitazone or any component of the preparation
Data sourced from ClinicalTrials.gov (NCT01150981). 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.