NCT00364221

Brief Summary

The metabolic syndrome is a collection of health risks that includes obesity, high blood pressure, high triglycerides, high blood sugar, low good cholesterol, and resistance to insulin. The purpose of this study is to find out if the medication, rosiglitazone, influences levels of fat cell proteins and alters insulin resistance in nondiabetic persons with the metabolic syndrome. This is an early step to see if a medication, such as rosiglitazone, will be beneficial in people who have the metabolic syndrome.

Trial Health

87
On Track

Trial Health Score

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

Timeline
Completed

Started Nov 2004

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, 2004

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2006

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

August 14, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 15, 2006

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2006

Completed
Last Updated

November 22, 2012

Status Verified

November 1, 2012

Enrollment Period

1.7 years

First QC Date

August 14, 2006

Last Update Submit

November 20, 2012

Conditions

Metabolic SyndromeInsulin Resistance

Interventions

RosiglitazoneDRUG

Eligibility Criteria

Age30 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Nondiabetic subjects with an NCEP/ATP III diagnosis of the metabolic syndrome

You may not qualify if:

  • Statin Medications, liver disease, cardiovascular disease, heart failure, diabetes, chronic kidney disease,

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Colorado at Denver and Health Sciences Center General Clinical Research Center

Denver, Colorado, 80262, United States

Location

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

Study Officials

  • Christina L Aquilante, PharmD

    University of Colorado, Denver

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 14, 2006

First Posted

August 15, 2006

Study Start

November 1, 2004

Primary Completion

July 1, 2006

Study Completion

October 1, 2006

Last Updated

November 22, 2012

Record last verified: 2012-11

Locations

US(1)