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

• Status: Completed
• Trial end date: 2011-05-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Emory University
• Collaborators: Daiichi Sankyo Inc.; Daiichi Sankyo, Inc.; National Center for Research Resources (NCRR); National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
• Treatments: Aspirin; Olmesartan; Olmesartan Medoxomil; Thioctic Acid

Criteria

Inclusion Criteria:

• Impaired glucose tolerance

Exclusion Criteria:

• Diagnosis of diabetes

• Taking an ACE inhibitor (ACE-I), angiotensin II receptor blocker (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