Treatment of Insulin Resistance in Hypertensive, Obese Adolescents

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2007 by Stanford University.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Stanford University
ClinicalTrials.gov Identifier:
NCT00185705
First received: September 9, 2005
Last updated: February 12, 2007
Last verified: February 2007
  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.


Condition Intervention
Hypertension
Insulin Resistance
Dyslipidemia
Drug: Telmisartan

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Randomized, Placebo Controlled, Double Blind Trial of Telmisartan in Hypertensive, Obese Adolescents

Resource links provided by NLM:


Further study details as provided by Stanford University:

Primary Outcome Measures:
  • 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 result in improved insulin levels and systolic blood pressure.

Secondary Outcome Measures:
  • Secondary outcome measures will include the effects of telmisartan on total cholesterol, triglyceride, HDL and LDL levels, body mass index (BMI), and body fat distribution.

Estimated Enrollment: 30
Study Start Date: October 2006
Estimated Study Completion Date: June 2007
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 result in improved insulin levels and systolic blood pressure. Secondary outcome measures will include the effects of telmisartan on total cholesterol, triglyceride, HDL and LDL levels, body mass index (BMI), and body fat distribution.

Specific Aims for to Test Hypothesis:

Aim #1: Determine the change in insulin sensitivity in adolescents with obesity and hyperinsulinemia before and after treatment with telmisartan. We hypothesize a significant increase in insulin sensitivity following medical treatment. We will measure fasting insulin and glucose levels for calculation of the homeostasis model assessment (HOMA) [29, 30]. Furthermore, we will calculate parameters of insulin production and insulin resistance from simultaneous measurements of glucose, insulin, and C-peptide levels during an oral glucose tolerance test (OGTT). We will check IGF BP-1 (insulin-like growth factor 1 binding protein) level as an indirect measurement of insulin resistance. Due to the risks associated with glucose clamps and continuous insulin infusion, we will not use this procedure in our study.

Aim #2: Determine the change in systolic blood pressure in adolescents with obesity and hypertension before and after treatment with telmisartan. We hypothesize a significant decrease in systolic blood pressure following medical treatment. Subjects will have blood pressure checked at each clinic visit.

Aim #3: Evaluate changes in lipid profile and body mass index as secondary outcome measures with telmisartan treatment. Subjects will have weight, height, and fasting lipid panel checked at each clinic visit.

Aim #4: Characterize fat distribution before and after telmisartan treatment. A subset of study participants will undergo magnetic resonance imaging (MRI) to characterize and separate abdominal adipose tissue into its subcutaneous and visceral components. A one-slice MRI will be obtained at 2 time-points during the study (weeks 0 and 12).

Aim #5: Determine the feasibility of using telmisartan for the treatment of hyperinsulinemia and hypertension in obese adolescents. Study results will provide necessary data to calculate the power needed for a multi-center, randomized, placebo-controlled trial of telmisartan.

  Eligibility

Ages Eligible for Study:   10 Years to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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).

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00185705

Contacts
Contact: Carolyn H Chi, MD 650-723-5791 cchi@stanford.edu
Contact: Darrell Wilson, MD 650-723-5791 dwilson@stanford.edu

Locations
United States, California
Stanford Medical Center Recruiting
Stanford, California, United States, 94305-5401
Contact: Carolyn H Chi, MD    650-723-5791    cchi@stanford.edu   
Principal Investigator: Carolyn H Chi, MD         
Sponsors and Collaborators
Stanford University
Investigators
Principal Investigator: Carolyn H Chi, MD Stanford Medical Center
  More Information

Publications:

ClinicalTrials.gov Identifier: NCT00185705     History of Changes
Other Study ID Numbers: Telmisartan adolescents
Study First Received: September 9, 2005
Last Updated: February 12, 2007
Health Authority: United States: Food and Drug Administration

Keywords provided by Stanford University:
Insulin resistance
obesity
hypertension
adolescents
telmisartan
lifestyle intervention

Additional relevant MeSH terms:
Hypertension
Insulin Resistance
Dyslipidemias
Vascular Diseases
Cardiovascular Diseases
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Lipid Metabolism Disorders
Telmisartan
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Angiotensin-Converting Enzyme Inhibitors
Protease Inhibitors
Enzyme Inhibitors

ClinicalTrials.gov processed this record on April 16, 2014