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Treatment of Insulin Resistance in Hypertensive, Obese Adolescents

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Contents

clinicaltrials.gov/study/NCT00185705
Is a
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Clinical study
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Clinical Study attributes

NCT Number
NCT001857050
Health Conditions in Trial
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Dyslipidemia
0
Hypertension
Hypertension
0
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Insulin resistance
0
Trial Recruitment Size
300
Trial Sponsor
Stanford University
Stanford University
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Clinical Trial Start Date
2006
0
Primary Completion Date
2007
0
Study Completion Date
2007
0
Clinical Trial Study Type
Interventional0
Interventional Trial Purpose
Treatment0
Interventional Trial Phase
Not Applicable0
Official Name
Randomized, Placebo Controlled, Double Blind Trial of Telmisartan in Hypertensive, Obese Adolescents0
Last Updated
March 18, 2020
0
Allocation Type
Randomized0
Intervention Model
Single Group Assignment0
Masking Type
Double0
Study 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, hypertensive children. Telmisartan is currently approved for treatment of adult hypertension. Recent adult studies, however, have shown telmisartan as an effective medication for lowering insulin levels and improving insulin sensitivity. We will enroll 30 obese adolescents, ages 10 to 18 years, and randomly assign half of the group to receive telmisartan and the other half to receive placebo (sugar-pill). We will obtain fasting glucose and insulin levels, as well as other markers for insulin sensitivity and cholesterol panel, at the beginning of the study, at each clinic visit in 4-week intervals, and at the end of the study. We will obtain an imaging study (computed tomography, CT scan) on 10 randomly selected study patients (5 from each group) to examine the distribution of fat tissue before and after treatment. Studies suggest that fat tissue in the subcutaneous tissue is less harmful that fat tissues surrounding internal organs, such as the liver. We will also provide nutritional handouts and exercise recommendations to each participant as a life-style intervention. Each participant will be given a diary to record his or her diet and exercise activities throughout the study.

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