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

This study has been completed.
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
Samir Malkani, University of Massachusetts, Worcester
ClinicalTrials.gov Identifier:
NCT01150981
First received: June 17, 2010
Last updated: February 25, 2012
Last verified: February 2012
  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

Resource links provided by NLM:


Further study details as provided by University of Massachusetts, Worcester:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01150981

Locations
United States, Massachusetts
UMass Medical School
Worcester, Massachusetts, United States, 01655
Sponsors and Collaborators
University of Massachusetts, Worcester
GlaxoSmithKline
Investigators
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 August 28, 2014