Status:
COMPLETED
Treating the Endothelium to Restore Insulin Sensitivity
Lead Sponsor:
Indiana University School of Medicine
Conditions:
Obesity
Insulin Resistance
Eligibility:
All Genders
20-55 years
Phase:
NA
Brief Summary
A study of 12 weeks' treatment with losartan or placebo, to test the hypothesis that RAS inhibition will improve insulin' vascular actions and therefore improve insulin sensitivity in skeletal muscle.
Detailed Description
Recent studies suggesting an effect of cardiovascular therapies to prevent diabetes remain unexplained. We hypothesize that these therapies improve vascular endothelial function allowing improved acti...
Eligibility Criteria
Inclusion
- Healthy
- Age 20-55
- Male and female
- Obese, defined as Males: BMI \>28 or \> 30% fat by DEXA scan or Bod Pod; Females: BMI \>30 or \> 33% fat by DEXA scan or Bod Pod
- Weight stable over at least 4 months
Exclusion
- Diabetes mellitus (ADA criteria)
- Age \<20 or \> 55 yrs
- Blood pressure \>160/90 or \< 90/65 mmHg
- Total cholesterol \>240 or LDL cholesterol \>160 mg/dL
- Baseline elevations in AST or ALT \> 3X ULN
- Baseline elevation in creatinine \>1.6 ng/mL
- Unexplained baseline elevation in creatine kinase \> 3X ULN
- Concurrent significant chronic medical illness including, but not limited to, human immunodeficiency virus infection, Syphilis, hepatitis B infection, or hepatitis C infection
- Pregnancy
- Known hypersensitivity or intolerance to the study agents
Key Trial Info
Start Date :
June 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2012
Estimated Enrollment :
17 Patients enrolled
Trial Details
Trial ID
NCT00402194
Start Date
June 1 2005
End Date
March 1 2012
Last Update
September 24 2013
Active Locations (1)
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1
Indiana University Hospital GCRC
Indianapolis, Indiana, United States, 46202