Salsalate Therapy to Reduce Insulin Resistance and Cardiovascular Risk

This study has been completed.
Sponsor:
Collaborator:
Joslin Diabetes Center
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00330733
First received: May 26, 2006
Last updated: April 15, 2014
Last verified: April 2014
Results First Received: December 18, 2013  
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: Atherosclerosis
Cardiovascular Disease
Inflammation
Insulin Resistance
Noninsulin-dependent Diabetes Mellitus
Interventions: Drug: Salsalate
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
Participants were veterans aged 21–75 years with impaired fasting glucose (i.e. ≥5.6 but <7 mmol/l) or impaired glucose tolerance (2 h glucose values ≥7.8 but <11.1 mmol/l) during a standard 2 h 75 g OGTT. Study participants were recruited from clinics and hospitals throughout the Phoenix and Boston VA Health Care systems.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
After enrolment there were 1 week screening, 3 week single-masked placebo run-in (to assess compliance) and 12 week randomised, double-masked treatment periods, with participants randomised 1:1 to receive salsalate or placebo. 78 individuals entered the run-in phase.

Reporting Groups
  Description
Arm 1

Matching placebo

Placebo: Matching placebo

Seventy-eight individuals entered the placebo run-in phase. Of these, 71 were randomised and 70 returned to receive study medication

Arm 2

Salsalate

Salsalate: Salsalate therapy


Participant Flow:   Overall Study
    Arm 1     Arm 2  
STARTED     37     34  
Received Study Medication     36     34  
COMPLETED     30     29  
NOT COMPLETED     7     5  



  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.
Seventy-eight individuals entered the placebo run-in phase. Of these, 71 were randomised and 70 returned to receive study medication

Reporting Groups
  Description
Arm 1

Matching placebo

Placebo: Matching placebo

Arm 2

Salsalate

Salsalate: Salsalate therapy, double-masked

Total Total of all reporting groups

Baseline Measures
    Arm 1     Arm 2     Total  
Number of Participants  
[units: participants]
  36     34     70  
Age  
[units: years]
Mean ± Standard Deviation
  57  ± 9     60  ± 6     58  ± 8  
Gender  
[units: participants]
     
Female     1     2     3  
Male     35     32     67  
Region of Enrollment  
[units: participants]
     
United States     36     34     70  
Euglycemic clamps [1]
[units: mg/ kg . min]
Mean ± Standard Deviation
  4.08  ± 1.46     3.8  ± 1.0     3.93  ± 1.27  
Oral Glucose Tolerance Test [2]
[units: mg/dl. min]
Mean ± Standard Deviation
  167  ± 21     165  ± 17     166  ± 19  
Fasting glucose  
[units: mg/dl]
Mean ± Standard Deviation
  105  ± 12     103  ± 10     104  ± 11  
[1] glucose disposal
[2] Area Under the Curve Measurement



  Outcome Measures

1.  Primary:   Change in Systemic Glucose Disposal- Glucose Infusion Rates   [ Time Frame: 3 months ]

2.  Secondary:   Glucose Area Under the Curve in These Subjects   [ Time Frame: 3 months ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

3.  Secondary:   Plasma Levels of a Variety of Inflammatory Proteins   [ Time Frame: 8 and 12 weeks ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

4.  Secondary:   Parameters of Cardiovascular Disease Risk, Including Glucose, Triglycerides, HDL and Blood Pressure   [ Time Frame: 8 and 12 weeks ]
Results not yet reported.   Anticipated Reporting Date:   09/2013   Safety Issue:   No

5.  Secondary:   Endothelial Dysfunction   [ Time Frame: 8 and 12 weeks ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No


  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
Since we did not measure endogenous glucose production and lipolysis, the effects on hepatic glucose and lipid metabolism deserve further study. Sufficient numbers of women were not included, with which to confidently extend these results to women


  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: Peter Reaven
Organization: Phoenix VA Health Care System
phone: 602 277 5551 ext 5817
e-mail: Peter.Reaven@va.gov


Publications of Results:

Responsible Party: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT00330733     History of Changes
Other Study ID Numbers: CLIN-011-05F
Study First Received: May 26, 2006
Results First Received: December 18, 2013
Last Updated: April 15, 2014
Health Authority: United States: Federal Government
United States: Food and Drug Administration