NCT01150981

Effect of Rosiglitazone on the Vascular Biology of Human Fat Tissue

Effect of Rosiglitazone on In-vivo Angiogenic Potential of Human Adipose Tissue

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 35 (actual)
• Sponsor: University of Massachusetts, Worcester · Academic / Other
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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.

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.

Conditions

• Metabolic Syndrome
• Insulin Resistance

Interventions

Type	Name	Description
DRUG	Rosiglitazone	One 8mg capsule daily for 6 weeks.
DRUG	Placebo	One capsule daily for 6 weeks.

Timeline

• Start date: 2006-11-01
• Primary completion: 2010-04-01
• Completion: 2010-04-01
• First posted: 2010-06-25
• Last updated: 2012-03-26
• Results posted: 2012-03-26

Locations

1 site across 1 country: United States