NCT01150981

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
35

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Nov 2006

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2006

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2010

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

June 17, 2010

Completed
8 days until next milestone

First Posted

Study publicly available on registry

June 25, 2010

Completed
1.8 years until next milestone

Results Posted

Study results publicly available

March 26, 2012

Completed
Last Updated

March 26, 2012

Status Verified

February 1, 2012

Enrollment Period

3.4 years

First QC Date

June 17, 2010

Results QC Date

December 16, 2011

Last Update Submit

February 25, 2012

Conditions

Metabolic SyndromeInsulin Resistance

Outcome Measures

Primary Outcomes (1)

  • Adipose Tissue Capillary Sprout Formation

    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.

    8 weeks

Secondary Outcomes (1)

  • Serum Adiponectin

    8 weeks

Study Arms (2)

Rosiglitazone

EXPERIMENTAL

One 8mg capsule daily for 6 weeks.

Drug: Rosiglitazone

Placebo

PLACEBO COMPARATOR

One capsule daily for 6 weeks.

Drug: Placebo

Interventions

RosiglitazoneDRUG

One 8mg capsule daily for 6 weeks.

Also known as: Avandia
Rosiglitazone
PlaceboDRUG

One capsule daily for 6 weeks.

Placebo

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UMass Medical School

Worcester, Massachusetts, 01655, United States

Location

Related Publications (1)

  • Gealekman O, Guseva N, Gurav K, Gusev A, Hartigan C, Thompson M, Malkani S, Corvera S. Effect of rosiglitazone on capillary density and angiogenesis in adipose tissue of normoglycaemic humans in a randomised controlled trial. Diabetologia. 2012 Oct;55(10):2794-2799. doi: 10.1007/s00125-012-2658-2. Epub 2012 Jul 31.

    PMID: 22847059DERIVED

MeSH Terms

Conditions

Metabolic SyndromeInsulin Resistance

Interventions

Rosiglitazone

Condition Hierarchy (Ancestors)

HyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

ThiazolidinedionesThiazolesSulfur CompoundsOrganic ChemicalsAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Results Point of Contact

Title
Samir Malkani, MD
Organization
University of Massachusetts Medical School
samir.malkani@umassmemorial.org
5088563800

Study Officials

  • Samir Malkani, MD

    UMass Worcester

    PRINCIPAL INVESTIGATOR

  • Silvia Corvera, MD

    UMass Worcester

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Study Principle Investigator

Study Record Dates

First Submitted

June 17, 2010

First Posted

June 25, 2010

Study Start

November 1, 2006

Primary Completion

April 1, 2010

Study Completion

April 1, 2010

Last Updated

March 26, 2012

Results First Posted

March 26, 2012

Record last verified: 2012-02

Locations

US(1)