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

NCT00122447 | Completed Results

• 4 other identifiers: IRB00000749UL1RR025008Sankyo CS-8661K23DK070715-01A1
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 2

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.

Conditions

Impaired Glucose Tolerance; Prediabetic State

Keywords

Prediabetic state; Cardiovascular disease; Diabetes; Glucose intolerance

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• AIM 1: Change in hsCRP (High Sensitivity C-reactive Peptide) Level

  12 months of intervention

Other Outcomes (1)

• AIM 2: Difference in FMD (Measure of Endothelial Function)

  Cross-sectional

Study Arms (4)

Anti-inflammatory agent

ACTIVE COMPARATOR

Aspirin (ASA)

Drug: Aspirin

Angiotensin receptor blocker (ARB)

ACTIVE COMPARATOR

Olmesartan (ARB)

Drug: Olmesartan

Antioxidant

ACTIVE COMPARATOR

Alpha lipoic acid (ALA)

Drug: Alpha lipoic acid

Placebo

PLACEBO COMPARATOR

Aspirin placebo once a day Olmesartan placebo once a day Alpha lipoic acid placebo twice a day

Drug: Placebo

Interventions

Aspirin DRUG

325 mg PO QD

Also known as: Bayer aspirin

Anti-inflammatory agent

Alpha lipoic acid DRUG

600 mg PO BID

Antioxidant

Olmesartan DRUG

40 mg PO QD

Also known as: Benicar

Angiotensin receptor blocker (ARB)

Placebo DRUG

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

Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Impaired glucose tolerance

You may not qualify if:

• 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

Sponsors & Collaborators

• Emory University: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator
• Daiichi Sankyo: collaborator
• National Center for Research Resources (NCRR): collaborator

Study Sites (2)

Grady Health System

Atlanta, Georgia, 30303, United States

Location

Emory University Hospital

Atlanta, Georgia, 30322, United States

Location

MeSH Terms

Conditions

Glucose Intolerance; Prediabetic State; Cardiovascular Diseases; Diabetes Mellitus

Interventions

Aspirin; Thioctic Acid; olmesartan; Olmesartan Medoxomil

Condition Hierarchy (Ancestors)

Hyperglycemia; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Salicylates; Hydroxybenzoates; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Carboxylic Acids; Thiophenes; Sulfur Compounds; Coenzymes; Enzymes and Coenzymes; Fatty Acids; Lipids; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Tetrazoles

Limitations and Caveats

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.

Results Point of Contact

• Title: Mary Rhee, M.D.
• Organization: Emory University School of Medicine

mrhee@emory.edu

404-778-1660

Study Officials

• Mary K Rhee, MD, MS

  Emory University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: July 21, 2005
• First Posted: July 22, 2005
• Study Start: May 1, 2005
• Primary Completion: May 1, 2011
• Study Completion: May 1, 2011
• Last Updated: December 5, 2013
• Results First Posted: June 20, 2012

Record last verified: 2013-11

Locations

US (2)