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

This study has been completed.

Sponsor:

Collaborators:

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

ClinicalTrials.gov Identifier:

NCT00122447

First received: July 21, 2005

Last updated: June 22, 2012

Last verified: June 2012

History of Changes

Results First Received: May 18, 2012

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
Conditions:	Impaired Glucose Tolerance Prediabetic State
Interventions:	Drug: Aspirin Drug: Alpha lipoic acid Drug: Olmesartan Drug: Placebo

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
266 subjects with IGT were contacted: 121 refused, 63 ineligible, 84 screened/enrolled. Among the 84 enrolled subjects: 1 was withdrawn, 13 dropped out before randomization, 70 were randomized (17 alpha lipoic acid, 18 aspirin, 18 olmesartan, 17 placebo). After randomization, 10 dropped out, and 3 were withdrawn.

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations

266 subjects with IGT were contacted: 121 refused, 63 ineligible, 84 screened/enrolled.

Among the 84 enrolled subjects:

1 was withdrawn, 13 dropped out before randomization, 70 were randomized (17 alpha lipoic acid, 18 aspirin, 18 olmesartan, 17 placebo).

After randomization, 10 dropped out, and 3 were withdrawn.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups

	Description
Aspirin (ASA) 325 mg PO Once Daily	Anti-inflammatory agent
Olmesartan (ARB) 40 mg PO Once Daily	Angiotensin receptor blocker (ARB)
Alpha Lipoic Acid (ALA) 600 mg PO Twice Daily	Antioxidant
Placebo	Aspirin placebo PO once a day Olmesartan placebo PO once a day Alpha lipoic acid placebo PO twice a day

Participant Flow: Overall Study

	Aspirin (ASA) 325 mg PO Once Daily	Olmesartan (ARB) 40 mg PO Once Daily	Alpha Lipoic Acid (ALA) 600 mg PO Twice Daily	Placebo
STARTED	18	18	17	17
COMPLETED	17	13	16	14
NOT COMPLETED	1	5	1	3

Baseline Characteristics

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Reporting Groups

	Description
Aspirin (ASA) 325 mg PO Once Daily	Anti-inflammatory agent
Olmesartan (ARB) 40 mg PO Once Daily	Angiotensin receptor blocker (ARB)
Alpha Lipoic Acid (ALA) 600 mg PO Twice Daily	Antioxidant
Placebo	Aspirin placebo PO once a day Olmesartan placebo PO once a day Alpha lipoic acid placebo PO twice a day
Total	Total of all reporting groups

Baseline Measures

	Aspirin (ASA) 325 mg PO Once Daily	Olmesartan (ARB) 40 mg PO Once Daily	Alpha Lipoic Acid (ALA) 600 mg PO Twice Daily	Placebo	Total
Number of Participants [units: participants]	18	18	17	17	70
Age [units: years] Mean ± Standard Deviation	51.4 ± 12.8	55.2 ± 8.5	52.4 ± 7.0	51.3 ± 11.7	52.6 ± 10.2
Gender [units: participants]
Female	13	10	10	6	39
Male	5	8	7	11	31
Race/Ethnicity, Customized [units: participants]
Black or African American	13	12	10	14	49
White	5	6	7	3	21

Outcome Measures

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1. Primary:

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

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2. Secondary:

AIM 1: Change in hsCRP (High Sensitivity C-reactive Peptide) Level [ Time Frame: 12 months of intervention ]

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3. Other Pre-specified:

AIM 2: Difference in FMD (Measure of Endothelial Function) [ Time Frame: Cross-sectional ]

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Serious Adverse Events

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Other Adverse Events

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More Information

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Certain Agreements:

All Principal Investigators ARE employed by the organization sponsoring the study.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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:

Name/Title: Mary Rhee, M.D.
Organization: Emory University School of Medicine
phone: 404-778-1660
e-mail: mrhee@emory.edu

No publications provided

Responsible Party:	Dr. Mary Rhee, 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

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