N/A
N=70
Cardiovascular Disease (CVD) Risk and Prevention in Early Glucose Intolerance
Impaired Glucose Tolerance · Prediabetic State
Bottom Line
View on ClinicalTrials.gov: NCT00122447 ↗Enrolled (actual)
70
Serious AEs
1.2%
Results posted
Jun 2012
Primary outcome: Primary: AIM 1: Change in Flow Mediated Dilation (FMD) (%) — -0.0012; 0.018; 0.014; 0.0053 percentage of arterial dilation change — p=0.943
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Aspirin (Drug); Alpha lipoic acid (Drug); Olmesartan (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Emory University
- Primary completion
- May 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY AIM 1: Change in Flow Mediated Dilation (FMD) (%) |
-0.0012; 0.018; 0.014; 0.0053 | 0.943 |
| SECONDARY AIM 1: Change in hsCRP (High Sensitivity C-reactive Peptide) Level |
-1.27; -2.34; 0.23; 0.32 | 0.449 |
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.
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT00122447). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.