Treatment of Insulin Resistance in Hypertensive, Obese Adolescents
Status:
Terminated
Trial end date:
2007-07-01
Target enrollment:
Participant gender:
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.