Effect of Rosiglitazone on the Vascular Biology of Human Fat Tissue (RAPA)
- Full Text View
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Metabolic Syndrome Insulin Resistance |
Drug: Rosiglitazone Drug: Placebo |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator, Outcomes Assessor) Primary Purpose: Basic Science |
| Official Title: | Effect of Rosiglitazone on In-vivo Angiogenic Potential of Human Adipose Tissue |
- Adipose Tissue Capillary Sprout Formation [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]Adipose tissue collected at 8 weeks was cut into ~1mm pieces which were embedded in individual wells of a 96 well plate containing growth factor depleted Matrigel. Wells were filled with media supplemented with endothelial growth factors, replaced every second day. Values for each patient are expressed as the difference in the average number of capillary branches (sprouts) formed by each of approximately 50 explants between day 14 and day 7. The number of branches forming on the periphery (defined as at least three cells in a branch structure) was counted by two investigators at day 7 and 14.
- Serum Adiponectin [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]Adiponectin concentrations in serum were measured in ng/ml, in both arms at baseline and at 8 weeks, i.e. 2 weeks after stopping drug or placebo treatment
| Enrollment: | 35 |
| Study Start Date: | November 2006 |
| Study Completion Date: | April 2010 |
| Primary Completion Date: | April 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Rosiglitazone
One 8mg capsule daily for 6 weeks.
|
Drug: Rosiglitazone
One 8mg capsule daily for 6 weeks.
Other Name: Avandia
|
|
Placebo Comparator: Placebo
One capsule daily for 6 weeks.
|
Drug: Placebo
One capsule daily for 6 weeks.
|
Detailed Description:
Adipocytes play a crucial role in the control of metabolic homeostasis, by sequestering excess calories in the form of triglycerides, and secreting cytokines that control systemic fuel utilization. Sustained excess calorie consumption results in adipocyte hypertrophy and hyperplasia, and like any expanding tissue, requires increased capillary expansion to nourish the enlarged adipose tissue mass. Recent reports indicate that decreased capillary density in adipose tissue of obese individuals correlates with insulin resistance, suggesting that an imbalance of angiogenesis and adipogenesis may underlie this condition. To determine whether improvement in insulin sensitivity is related to changes in adipose tissue capillary development, we conducted a randomized, double-blind, placebo-controlled trial to determine capillary density, angiogenic growth potential, and metabolic parameters in healthy human volunteers before and after treatment with rosiglitazone, a potent insulin sensitizer.
Eligibility| Ages Eligible for Study: | 18 Years to 55 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
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
Contacts and Locations| United States, Massachusetts | |
| UMass Medical School | |
| Worcester, Massachusetts, United States, 01655 | |
| Principal Investigator: | Samir Malkani, MD | UMass Worcester |
| Principal Investigator: | Silvia Corvera, MD | UMass Worcester |
More Information
No publications provided by University of Massachusetts, Worcester
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Samir Malkani, Study Principle Investigator, University of Massachusetts, Worcester |
| ClinicalTrials.gov Identifier: | NCT01150981 History of Changes |
| Other Study ID Numbers: | 12196 |
| Study First Received: | June 17, 2010 |
| Results First Received: | December 16, 2011 |
| Last Updated: | February 25, 2012 |
| Health Authority: | United States: Institutional Review Board |
Additional relevant MeSH terms:
|
Insulin Resistance Metabolic Syndrome X Hyperinsulinism Glucose Metabolism Disorders Metabolic Diseases |
Rosiglitazone Hypoglycemic Agents Physiological Effects of Drugs Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 23, 2013