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

This study has been completed.
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Daiichi Sankyo Inc.
National Center for Research Resources (NCRR)
Information provided by (Responsible Party):
Dr. Mary Rhee, Emory University Identifier:
First received: July 21, 2005
Last updated: November 12, 2013
Last verified: November 2013
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 Intervention
Impaired Glucose Tolerance
Prediabetic State
Drug: Aspirin
Drug: Alpha lipoic acid
Drug: Olmesartan
Drug: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: CVD Risk and Prevention in Early Glucose Intolerance

Resource links provided by NLM:

Further study details as provided by Emory University:

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

Other Outcome Measures:
  • 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.

Enrollment: 84
Study Start Date: May 2005
Study Completion Date: May 2011
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Show Detailed Description


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: 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 Identifier: NCT00122447     History of Changes
Other Study ID Numbers: IRB00000749
UL1RR025008 ( US NIH Grant/Contract Award Number )
Sankyo CS-866 ( Other Identifier: Daiichi Sankyo )
1K23DK070715-01A1 ( US NIH Grant/Contract Award Number )
Study First Received: July 21, 2005
Results First Received: May 18, 2012
Last Updated: November 12, 2013

Keywords provided by 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 processed this record on May 22, 2017