Status:
TERMINATED
Treatment of Insulin Resistance in Hypertensive, Obese Adolescents
Lead Sponsor:
Stanford University
Conditions:
Hypertension
Insulin Resistance
Eligibility:
All Genders
10-18 years
Phase:
NA
Brief Summary
In this study, we propose using telmisartan, an angiotensin II receptor antagonist with PPAR-gamma modulating activity, for a 12-week period to decrease blood pressure and insulin levels in obese, hyp...
Detailed Description
Hypothesis: This pilot study will provide data essential for designing a larger trial to test the hypothesis that telmisartan treatment of obese children with insulin resistance and hypertension will ...
Eligibility Criteria
Inclusion
- Ages between 10.00 and 17.99 years
- Body mass index (BMI) ≥ 95th percentile for age and gender using the CDC data
- SBP ≥ 95th percentile for age, gender, and height using the fourth report from the National High Blood Pressure Education Program (NHBPEP) guidelines.
- Fasting plasma insulin concentration ≥ 20 U/mL will be required for study entry. This insulin concentration is commonly used for defining insulin resistance.
Exclusion
- Subjects will be excluded from the study if they have known diabetes as defined by the American Diabetes Association criteria, prior drug therapy to treat diabetes or insulin resistance, recent glucocorticoid therapy within 3 months of the screening visit, current drug therapy to treat hypertension, elevated creatinine (\> 1.2mg/dL), elevated liver enzymes (ALT \> 80), history or current alcohol ingestion, existing pregnancy or high-risk of becoming pregnant, other serious medical condition that the investigator determines may put the subject at undue risk if enrolled in the study, or taking medications with potential drug-drug interactions (anticoagulant, digoxin, diuretics).
Key Trial Info
Start Date :
October 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2007
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00185705
Start Date
October 1 2006
End Date
July 1 2007
Last Update
March 18 2020
Active Locations (1)
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1
Stanford Medical Center
Stanford, California, United States, 94305-5401