©2022 Stanford Medicine
Treatment of Insulin Resistance in Hypertensive, Obese Adolescents
Not Recruiting
Trial ID: NCT00185705
Purpose
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.
Official Title
Randomized, Placebo Controlled, Double Blind Trial of Telmisartan in Hypertensive, Obese Adolescents
Eligibility
Inclusion Criteria:
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 Criteria:
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).
Intervention(s):
drug: Telmisartan
Not Recruiting
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Carolyn H Chi, MD
650-723-5791