Effect of Rosiglitazone on the Vascular Biology of Human Fat Tissue (RAPA)

University of Massachusetts, Worcester

Status and phase: Completed; Phase 2

Conditions: Insulin Resistance; Metabolic Syndrome

Treatments: Drug: Placebo; Drug: Rosiglitazone

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01150981

12196

Details and patient eligibility

About

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.

Full 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.

Enrollment: 35 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Overweight but otherwise in good general health.
2. Age 18 - 55 years.
3. Normal glucose tolerance.
4. Stable weight with BMI (27-44).
5. Stable medication use for the preceding month.
6. BP < 150/90.
7. Negative pregnancy test (*HCG), if female and of childbearing potential.
8. Practicing, and willing to continue to practice appropriate contraception throughout the study if a female of childbearing potential.

Exclusion criteria

1. Serious medical illness.
2. Pregnancy.
3. Tobacco use within the past 6 months.
4. Prior or current treatment with a thiazolidinedione.
5. Patients who have received an investigational drug in the past 30 days.
6. Use of systemic corticosteroids.
7. Known or suspected allergy to Rosiglitazone or any component of the preparation

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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35 participants in 2 patient groups, including a placebo group

Rosiglitazone

Experimental group

Description:

One 8mg capsule daily for 6 weeks.

Treatment:

Drug: Rosiglitazone

Placebo

Placebo Comparator group

Description:

One capsule daily for 6 weeks.

Treatment:

Drug: Placebo