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Salsalate Therapy to Reduce Insulin Resistance and Cardiovascular Risk

NCT00330733 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 71

Last updated 2020-01-21

Study results available
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Summary

The hypothesis is that salsalate therapy may be an effective and safe method to modulate inflammation in metabolically-critical tissues and thus reduce insulin resistance and its related complications.

The objectives of the study are to (1) determine whether salsalate therapy improves insulin resistance in subjects with IGT and changes in glucose area under the curve following a standard oral glucose tolerance test (OGTT); (2) determine whether salsalate therapy reduces a) plasma levels of a variety of well established inflammatory proteins and b) mononuclear cell inflammatory activity to provide evidence of reduced systemic and tissue inflammation, respectively; and (3)also determine whether salsalate therapy improves parameters of cardiovascular disease risk, including features of metabolic syndrome (fasting glucose, triglycerides, HDL, and blood pressure) as well as endothelial dysfunction.

Conditions

Interventions

DRUG

Salsalate

Participants were randomized to 12-week treatment with up to 4 g/day.

DRUG

Placebo

Participants were randomized to 12-week treatment matching the active salsalate arm.

Sponsors & Collaborators

  • Joslin Diabetes Center

    collaborator OTHER

  • VA Office of Research and Development

    lead FED

Principal Investigators

  • Peter Reaven, MD · Carl T. Hayden VA Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
21 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-01-31
Primary Completion
2010-08-31
Completion
2010-09-30

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00330733 on ClinicalTrials.gov