NCT00122447|CompletedResults
Cardiovascular Disease (CVD) Risk and Prevention in Early Glucose Intolerance
CVD Risk and Prevention in Early Glucose Intolerance
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CVD Risk and Prevention in Early Glucose Intolerance
Sponsor study identifier
Secondary identifiers
interventional
84
1 country
2
Study Start
May 2005
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
May 2011
Actual (reported)Study Completion
May 2011
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
May 2011
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
May 2005
Date type not reportedThis date has not been verified as actual or estimated.
July 21, 2005
Actual (reported)July 22, 2005
Actual (reported)May 2011
Actual (reported)May 2011
Actual (reported)June 20, 2012
Actual (reported)AIM 1: Change in Flow Mediated Dilation (FMD) (%)
Surrogate measure of endothelial function defined as the percent change in dilation of the brachial artery after cuff compression of arm compared to before cuff compression
12 months of intervention
AIM 1: Change in hsCRP (High Sensitivity C-reactive Peptide) Level
12 months of intervention
AIM 2: Difference in FMD (Measure of Endothelial Function)
Cross-sectional
Aspirin (ASA)
Olmesartan (ARB)
Alpha lipoic acid (ALA)
Grady Health System
Atlanta, Georgia, 30303, United States
Emory University Hospital
Atlanta, Georgia, 30322, United States
Not fully powered due to under-enrollment and high drop-out rate. Higher than anticipated precision error of FMD measures. Possible Hawthorne effect with lifestyle changes. Short treatment period relative to long-term CVD risk in prediabetes.
Mary K Rhee, MD, MS
Emory University
84 participants (actual enrollment reported by the registry).
First Submitted
July 21, 2005
First Posted
July 22, 2005
Study Start
May 2005
Date type not reportedThis date has not been verified as actual or estimated.
Step Up For Health Study: A Pedometer and Website Intervention in Those With Prediabetes
Aspirin placebo once a day Olmesartan placebo once a day Alpha lipoic acid placebo twice a day
40 mg PO QD
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
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
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Primary Completion
May 2011
Actual (reported)Study Completion
May 2011
Actual (reported)Last Updated
December 5, 2013
Results First Posted
June 20, 2012
Record last verified: 2013-11
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Source: ClinicalTrials.gov.
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