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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00122447
Recruitment Status : Completed
First Posted : July 22, 2005
Results First Posted : June 20, 2012
Last Update Posted : December 5, 2013
Information provided by (Responsible Party):

Study Description
Brief 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.

Condition or disease Intervention/treatment
Impaired Glucose Tolerance Prediabetic State Drug: Aspirin Drug: Alpha lipoic acid Drug: Olmesartan Drug: Placebo

  Show Detailed Description

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 84 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: CVD Risk and Prevention in Early Glucose Intolerance
Study Start Date : May 2005
Primary Completion Date : May 2011
Study Completion Date : May 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Active Comparator: Anti-inflammatory agent
Aspirin (ASA)
Drug: Aspirin
325 mg PO QD
Other Name: Bayer aspirin
Active Comparator: Angiotensin receptor blocker (ARB)
Olmesartan (ARB)
Drug: Olmesartan
40 mg PO QD
Other Name: Benicar
Active Comparator: Antioxidant
Alpha lipoic acid (ALA)
Drug: Alpha lipoic acid
600 mg PO BID
Placebo Comparator: Placebo
Aspirin placebo once a day Olmesartan placebo once a day Alpha lipoic acid placebo twice a day
Drug: Placebo

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

Outcome Measures

Primary Outcome Measures :
  1. AIM 1: Change in Flow Mediated Dilation (FMD) (%) [ Time Frame: 12 months of intervention ]
    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

Secondary Outcome Measures :
  1. AIM 1: Change in hsCRP (High Sensitivity C-reactive Peptide) Level [ Time Frame: 12 months of intervention ]
    Inflammatory marker

Other Outcome Measures:
  1. AIM 2: Difference in FMD (Measure of Endothelial Function) [ Time Frame: Cross-sectional ]

    Comparison of FMD (measure of endothelial function) between NGT, IGT and diabetes at baseline. FMD is a 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.

    No analysis was conducted due to under-recruitment.

Eligibility Criteria

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00122447

United States, Georgia
Grady Health System
Atlanta, Georgia, United States, 30303
Emory University Hospital
Atlanta, Georgia, United States, 30322
Sponsors and Collaborators
Emory University
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Daiichi Sankyo, Inc.
National Center for Research Resources (NCRR)
Principal Investigator: Mary K Rhee, MD, MS Emory University
More Information

Responsible Party: Dr. Mary Rhee, Assistant Professor, Emory University
ClinicalTrials.gov Identifier: NCT00122447     History of Changes
Other Study ID Numbers: IRB00000749
UL1RR025008 ( U.S. NIH Grant/Contract )
Sankyo CS-866 ( Other Identifier: Daiichi Sankyo )
1K23DK070715-01A1 ( U.S. NIH Grant/Contract )
First Posted: July 22, 2005    Key Record Dates
Results First Posted: June 20, 2012
Last Update Posted: December 5, 2013
Last Verified: November 2013

Keywords provided by Dr. Mary Rhee, Emory University:
Prediabetic state
Cardiovascular disease
Glucose intolerance

Additional relevant MeSH terms:
Cardiovascular Diseases
Glucose Intolerance
Prediabetic State
Glucose Metabolism Disorders
Metabolic Diseases
Diabetes Mellitus
Endocrine System Diseases
Olmesartan Medoxomil
Thioctic Acid
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Antihypertensive Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists