NCT00733174

Brief Summary

Subjects with impaired glucose tolerance will be randomized to either rosiglitazone or placebo for a 18 month period. The study will look at baseline, 12 month and 18 month data for exercise tolerance, coronary artery calcification and diabetes indicators.

Trial Health

55
Monitor

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

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

March 1, 2004

Completed
4.4 years until next milestone

First Submitted

Initial submission to the registry

August 8, 2008

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 12, 2008

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2009

Completed
Last Updated

August 12, 2008

Status Verified

August 1, 2008

Enrollment Period

4.8 years

First QC Date

August 8, 2008

Last Update Submit

August 11, 2008

Conditions

Impaired Glucose Tolerance

Keywords

IGT

Outcome Measures

Primary Outcomes (1)

  • Effect of rosiglitazone vs. placebo on exercise tolerance

    18 months

Study Arms (2)

1

EXPERIMENTAL

Rosiglitazone

Drug: Rosiglitazone

2

PLACEBO COMPARATOR

Placebo

Drug: Placebo

Interventions

RosiglitazoneDRUG

tablet

1
PlaceboDRUG
2

Eligibility Criteria

Age25 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Subjects must sign the informed consent to participate in the study.
  • Male or female adults ages 25-75 years.
  • Female subjects must be postmenopausal (i.e., \> 6 months without menstrual period), surgically sterile, or using effective barrier contraceptive measures (Intra-Uterine Device (IUD), diaphragm with spermicide or condom with spermicide).
  • Women of childbearing potential must use effective barrier contraceptive measures for at least 1 month prior to visit 1, and should continue to use the same contraceptive method during the study and for 30 days after discontinuing study medication.
  • Female subjects of childbearing potential must have a negative urine pregnancy test.
  • Subjects must have an FPG \< 126 mg/dL at Screening 1 AND Screening 2, a C-peptide \> 2.0 ng/mL and a HbA1c \<6.5%.
  • Subjects must have a Body Mass Index 25-40 (must be \< 300 lbs).
  • Subjects must have a 2 hour post-prandial glucose 140-199 mg/dL at Screening 1 AND Screening 2. If the 2 hour post-prandial glucose result is 130-139 mg/dL at Screening 2, subjects will be allowed to repeat the OGTT.

You may not qualify if:

  • Women who are lactating, pregnant, or planning to become pregnant during the study will be excluded.
  • Women using hormone contraception or on hormone replacement therapy will be excluded.
  • Subjects with any clinically significant abnormality identified on the Screening physical examination, laboratory tests, or electrocardiogram which, in the judgment of the Investigator, would preclude safe completion of the study will also be excluded.
  • Use of any other investigational agents or participation in any other investigational studies during the study period will not be allowed.
  • Patients will also be excluded if there is a presence of clinically significant hepatic disease or patient with LFT levels \> 2 times the upper limit of normal laboratory range
  • Subjects with a documented history of significant hypersensitivity (e.g., difficulty swallowing, difficulty breathing, tachycardia or skin reaction) to thiazolidinediones
  • Subjects with any contraindications to rosiglitazone
  • Presence of unstable or severe (New York Heart Association-NYHA class 3 or 4) angina, including angina requiring continual nitrate treatment for symptomatic relief, or coronary insufficiency
  • Subjects with HYHA class 3 or 4 of congestive heart failure requiring drug therapy; systolic blood pressure \> 160 mmHg or diastolic blood pressure \> 100 mmHg
  • History of cancer (except non-melanomatous skin carcinoma)
  • Active alcohol or drug abuse within the last 6 months
  • Subjects with chronic diseases requiring periodic or intermittent treatment with oral or intravenous corticosteroids
  • Subjects who are unable to understand dosing directions or swallow study medications
  • Subjects who are currently smoking
  • Subjects unable to adhere to protocol requirements.
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

South Federal Family Practice

Denver, Colorado, 80219, United States

RECRUITING

MeSH Terms

Conditions

Glucose Intolerance

Interventions

Rosiglitazone

Condition Hierarchy (Ancestors)

HyperglycemiaGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

ThiazolidinedionesThiazolesSulfur CompoundsOrganic ChemicalsAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Central Study Contacts

Stacey Mitchell, BSN, RN

CONTACT

303-399-8020stacey.mitchell@va.gov

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 8, 2008

First Posted

August 12, 2008

Study Start

March 1, 2004

Primary Completion

January 1, 2009

Last Updated

August 12, 2008

Record last verified: 2008-08

Locations

US(1)