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

This study is currently recruiting participants.

Verified by Emory University, July 2005

Sponsors and Collaborators:	Emory University National Center for Research Resources (NCRR) Daiichi Sankyo Inc.
Information provided by:	Emory University
ClinicalTrials.gov Identifier:	NCT00122447

Purpose

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.

Condition	Intervention
Impaired Glucose Tolerance Prediabetic State	Drug: Aspirin Drug: Alpha lipoic acid Drug: Olmesartan Drug: Placebo

MedlinePlus related topics: Diabetes

Drug Information available for: Dextrose Thioctic acid Acetylsalicylic acid Olmesartan Olmesartan medoxomil

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study
Official Title:	CVD Risk and Prevention in Early Glucose Intolerance

Further study details as provided by Emory University:

Primary Outcome Measures:

Brachial artery flow mediated dilation (endothelial function)

Secondary Outcome Measures:

Insulin sensitivity and beta cell function
Inflammatory markers
Markers of oxidative stress

Estimated Enrollment:	120
Study Start Date:	May 2005
Estimated Study Completion Date:	May 2009

Show Detailed Description

Eligibility

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Impaired glucose tolerance

Exclusion Criteria:

Diagnosis of diabetes
Taking an ACE-I, ARB, or aspirin
Have systolic blood pressure >140 mm Hg
Have a chronic inflammatory disorder (i.e. rheumatoid arthritis, inflammatory bowel disease, sinusitis)
Vascular disease (cardiac, peripheral, cerebral)
Renal insufficiency or hepatic abnormalities
Gastrointestinal bleeding (defined as gastric or duodenal ulcer, hematemesis, and/or blood in the stool) or significant other upper gastrointestinal problems (i.e. gastritis) within the previous 6 months
Anemia or a history of bleeding disorder
Have a history of ARB or aspirin allergy
Have the syndrome of asthma, rhinitis, and nasal polyps
Have other medical problems which would preclude taking potential study medications for 12 months
Are pregnant or have a positive pregnancy test
Are breast feeding
Are unable or unwilling to tolerate having one catheter in each arm for 4 hours
Have health status such that the envisioned blood sampling would confer a physiologic risk
Have other physical, social, or behavioral problems which would decrease the likelihood that they would remain in the study for 12 months
Do not appear capable of giving informed consent

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00122447

Contacts

Contact: Edith Woodward, RN

404-778-1688

edith_woodward@emoryhealthcare.org

Locations

United States, Georgia
Emory University Hospital	Recruiting
Atlanta, Georgia, United States, 30322
Contact: Edith Woodward, RN 404-778-1688 edith_woodward@emoryhealthcare.org
Principal Investigator: Mary K Rhee, MD, MS
Grady Health System	Recruiting
Atlanta, Georgia, United States, 30303
Contact: Edith Woodward, RN 404-778-1688 edith_woodward@emoryhealthcare.org

Sponsors and Collaborators

Emory University

National Center for Research Resources (NCRR)

Daiichi Sankyo Inc.

Investigators

Principal Investigator:

Mary K Rhee, MD, MS

Emory University

More Information

Study ID Numbers:	RR-017643-MKR, Sankyo-CS-866
Study First Received:	July 21, 2005
Last Updated:	July 27, 2005
ClinicalTrials.gov Identifier:	NCT00122447
Health Authority:	United States: Food and Drug Administration

Keywords provided by Emory University:

Prediabetic state
Cardiovascular disease
Diabetes
Glucose intolerance

Study placed in the following topic categories:

Metabolic Diseases
Hyperglycemia
Aspirin
Glucose Intolerance
Prediabetic State
Diabetes Mellitus

Endocrine System Diseases
Olmesartan medoxomil
Endocrinopathy
Metabolic disorder
Glucose Metabolism Disorders
Thioctic Acid

Additional relevant MeSH terms:

Antioxidants
Vitamin B Complex
Molecular Mechanisms of Pharmacological Action
Growth Substances
Vitamins

Physiological Effects of Drugs
Cardiovascular Diseases
Micronutrients
Protective Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009