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Completed

NCT Number: NCT01150981

Effect of Rosiglitazone on the Vascular Biology of Human Fat Tissue

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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Key information

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

UMass Medical School

Worcester, Massachusetts, 01655, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

rosiglitazone

Drug

One 8mg capsule daily for 6 weeks.

Other names: Avandia

Placebo

Drug

One capsule daily for 6 weeks.

Primary outcomes

  1. Adipose Tissue Capillary Sprout Formation

    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.

Secondary outcomes

  1. Serum Adiponectin

    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

Sponsors and collaborators

Lead sponsor

University of Massachusetts, Worcester

Other

Collaborators

  • GlaxoSmithKline

Registry information

Official study title

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

Acronym: RAPA

Important dates

Study start
2006
Primary completion
2010
Study completion
2010
First posted
Jun 25, 2010
Registry last updated
Mar 26, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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