N/A
N=17
Treating the Endothelium to Restore Insulin Sensitivity
Obesity · Insulin Resistance · Impaired Glucose Tolerance · Pre-diabetes
Bottom Line
View on ClinicalTrials.gov: NCT00402194 ↗Enrolled (actual)
17
Serious AEs
0.0%
Results posted
Sep 2013
Primary outcome: Primary: Leg Blood Flow Response to Insulin — 0.24; 0.26; 0.353; 0.046 Liters/minute
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Losartan (Drug)
- Age
- Adult · 20+ yrs
- Sex
- All
- Sponsor
- Indiana University
- Primary completion
- Nov 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Leg Blood Flow Response to Insulin |
0.24; 0.26; 0.353; 0.046 | — |
| PRIMARY Insulin-stimulated Leg Glucose Uptake |
0.42; 0.30 | — |
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.
Eligibility Criteria
Inclusion Criteria
- 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 Criteria
- Diabetes mellitus (ADA criteria)
- Age 55 yrs
- Blood pressure >160/90 or 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
Data sourced from ClinicalTrials.gov (NCT00402194). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.