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

This study has been completed.
Sponsor:
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: November 12, 2013
Last verified: November 2013
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1 was withdrawn, 13 dropped out before randomization, 70 were randomized (17 alpha lipoic acid, 18 aspirin, 18 olmesartan, 17 placebo).

After randomization, 10 dropped out, and 3 were withdrawn.


Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

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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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

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
  Show All Outcome Measures

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

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

3.  Other Pre-specified:   AIM 2: Difference in FMD (Measure of Endothelial Function)   [ Time Frame: Cross-sectional ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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.


  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


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: IRB00000749, UL1RR025008, Sankyo CS-866, 1K23DK070715-01A1
Study First Received: July 21, 2005
Results First Received: May 18, 2012
Last Updated: November 12, 2013
Health Authority: United States: Food and Drug Administration