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Cardiovascular Disease (CVD) Risk and Prevention in Early Glucose Intolerance

NCT00122447 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 84

Last updated 2013-12-05

Study results available
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Summary

The purpose of this study is to determine whether cardiovascular disease (CVD) risk markers, β-cell function, and insulin sensitivity can be improved by targeting mechanisms of both diabetes and CVD - using an antioxidant, an angiotensin II receptor blocker (ARB), or an anti-inflammatory agent - in patients with impaired glucose tolerance (IGT) in a randomized, controlled trial.

Conditions

  • Impaired Glucose Tolerance
  • Prediabetic State

Interventions

DRUG

Aspirin

325 mg PO QD

DRUG

Alpha lipoic acid

600 mg PO BID

DRUG

Olmesartan

40 mg PO QD

DRUG

Placebo

Identical placebo for each active comparator: placebo aspirin 325 mg PO QD; placebo for alpha lipoic acid 600 mg PO BID; placebo for olmesartan 40 mg PO QD

Sponsors & Collaborators

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

    collaborator NIH

  • Daiichi Sankyo

    collaborator INDUSTRY

  • National Center for Research Resources (NCRR)

    collaborator NIH

  • Emory University

    lead OTHER

Principal Investigators

  • Mary K Rhee, MD, MS · Emory University

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2005-05-31
Primary Completion
2011-05-31
Completion
2011-05-31

Countries

  • United States

Study Locations

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Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00122447 on ClinicalTrials.gov