UMass Medical School
Worcester, Massachusetts, 01655, United States
NCT Number: NCT01150981
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.
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Notify Me18 year–55 year
All sexes
Interventional
Phase 2
Worcester, Massachusetts, 01655, United States
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
One 8mg capsule daily for 6 weeks.
Other names: Avandia
One capsule daily for 6 weeks.
Time frame: 8 weeks
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.
Time frame: 8 weeks
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
University of Massachusetts, Worcester
Other
Effect of Rosiglitazone on In-vivo Angiogenic Potential of Human Adipose Tissue
Acronym: RAPA
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