Cardiovascular Disease (CVD) Risk and Prevention in Early Glucose Intolerance
Completed · Not applicable · Has a placebo group
Conditions studied: Impaired Glucose Tolerance, Prediabetic State
In brief
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.
Key facts
- Study ID
- NCT00122447
- Run by
- Emory University
- People needed
- 84
- Starts
- 2005-05-01
- Expected to finish
- 2011-05-01
- Last updated by the study team
- 2013-12-05
Who can join
Age: 18 and older, up to 75. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- Impaired glucose tolerance
You may not qualify if…
- 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
Where it is running
- Grady Health System — Atlanta, Georgia, United States
- Emory University Hospital — Atlanta, Georgia, United States
Full record on ClinicalTrials.gov
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