Cardiovascular Disease (CVD) Risk and Prevention in Early Glucose Intolerance
This study has been completed.
Sponsor:
Emory University
Collaborators:
Daiichi Sankyo Inc.
Information provided by (Responsible Party):
Dr. Mary Rhee, Emory University
ClinicalTrials.gov Identifier:
NCT00122447
First received: July 21, 2005
Last updated: June 22, 2012
Last verified: June 2012
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Purpose
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 Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, 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 ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]Inflammatory marker
| 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 Eligibility| Ages Eligible for Study: | 18 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00122447
Locations
| United States, Georgia | |
| Emory University Hospital | |
| Atlanta, Georgia, United States, 30322 | |
| Grady Health System | |
| Atlanta, Georgia, United States, 30303 | |
Sponsors and Collaborators
Emory University
Daiichi Sankyo Inc.
Investigators
| Principal Investigator: | Mary K Rhee, MD, MS | Emory University |
More Information
No publications provided
| Responsible Party: | Dr. Mary Rhee, Assistant Professor, Emory University |
| ClinicalTrials.gov Identifier: | NCT00122447 History of Changes |
| Other Study ID Numbers: | 1 K23 DK070715-01A1, UL1RR025008, Sankyo CS-866, 1K23DK070715-01A1 |
| Study First Received: | July 21, 2005 |
| Results First Received: | May 18, 2012 |
| Last Updated: | June 22, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Emory University:
|
Prediabetic state Cardiovascular disease Diabetes Glucose intolerance |
Additional relevant MeSH terms:
|
Cardiovascular Diseases Glucose Intolerance Prediabetic State Hyperglycemia Glucose Metabolism Disorders Metabolic Diseases Diabetes Mellitus Endocrine System Diseases Aspirin Anti-Inflammatory Agents Olmesartan medoxomil Thioctic Acid Olmesartan Angiotensin Receptor Antagonists Anti-Inflammatory Agents, Non-Steroidal |
Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Pharmacologic Actions Therapeutic Uses Antirheumatic Agents Fibrinolytic Agents Fibrin Modulating Agents Molecular Mechanisms of Pharmacological Action Cardiovascular Agents Hematologic Agents Platelet Aggregation Inhibitors Cyclooxygenase Inhibitors |
ClinicalTrials.gov processed this record on May 19, 2013