- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00185705
Treatment of Insulin Resistance in Hypertensive, Obese Adolescents
Randomized, Placebo Controlled, Double Blind Trial of Telmisartan in Hypertensive, Obese Adolescents
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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California
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Stanford, California, United States, 94305-5401
- Stanford Medical Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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).
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: Double
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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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.
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Secondary Outcome Measures
Outcome Measure |
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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.
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Carolyn H Chi, MD, Stanford Medical Center
Publications and helpful links
General Publications
- Berenson GS. Childhood risk factors predict adult risk associated with subclinical cardiovascular disease. The Bogalusa Heart Study. Am J Cardiol. 2002 Nov 21;90(10C):3L-7L. doi: 10.1016/s0002-9149(02)02953-3.
- Duncan GE, Li SM, Zhou XH. Prevalence and trends of a metabolic syndrome phenotype among u.s. Adolescents, 1999-2000. Diabetes Care. 2004 Oct;27(10):2438-43. doi: 10.2337/diacare.27.10.2438.
- de Ferranti SD, Gauvreau K, Ludwig DS, Neufeld EJ, Newburger JW, Rifai N. Prevalence of the metabolic syndrome in American adolescents: findings from the Third National Health and Nutrition Examination Survey. Circulation. 2004 Oct 19;110(16):2494-7. doi: 10.1161/01.CIR.0000145117.40114.C7. Epub 2004 Oct 11.
- Ferrannini E, Haffner SM, Mitchell BD, Stern MP. Hyperinsulinaemia: the key feature of a cardiovascular and metabolic syndrome. Diabetologia. 1991 Jun;34(6):416-22. doi: 10.1007/BF00403180.
- Freedman DS, Khan LK, Dietz WH, Srinivasan SR, Berenson GS. Relationship of childhood obesity to coronary heart disease risk factors in adulthood: the Bogalusa Heart Study. Pediatrics. 2001 Sep;108(3):712-8. doi: 10.1542/peds.108.3.712.
- Hardin DS, Hebert JD, Bayden T, Dehart M, Mazur L. Treatment of childhood syndrome X. Pediatrics. 1997 Aug;100(2):E5. doi: 10.1542/peds.100.2.e5.
- Kaplan F, Al-Majali K, Betteridge DJ. PPARS, insulin resistance and type 2 diabetes. J Cardiovasc Risk. 2001 Aug;8(4):211-7. doi: 10.1177/174182670100800405.
- Kurtz TW, Pravenec M. Antidiabetic mechanisms of angiotensin-converting enzyme inhibitors and angiotensin II receptor antagonists: beyond the renin-angiotensin system. J Hypertens. 2004 Dec;22(12):2253-61. doi: 10.1097/00004872-200412000-00003.
- Owens S, Gutin B, Barbeau P, Litaker M, Allison J, Humphries M, Okuyama T, Le NA. Visceral adipose tissue and markers of the insulin resistance syndrome in obese black and white teenagers. Obes Res. 2000 Jul;8(4):287-93. doi: 10.1038/oby.2000.34.
- Sinaiko AR, Steinberger J, Moran A, Prineas RJ, Jacobs DR Jr. Relation of insulin resistance to blood pressure in childhood. J Hypertens. 2002 Mar;20(3):509-17. doi: 10.1097/00004872-200203000-00027.
- Sorof JM, Lai D, Turner J, Poffenbarger T, Portman RJ. Overweight, ethnicity, and the prevalence of hypertension in school-aged children. Pediatrics. 2004 Mar;113(3 Pt 1):475-82. doi: 10.1542/peds.113.3.475.
- Steinberger J, Daniels SR; American Heart Association Atherosclerosis, Hypertension, and Obesity in the Young Committee (Council on Cardiovascular Disease in the Young); American Heart Association Diabetes Committee (Council on Nutrition, Physical Activity, and Metabolism). Obesity, insulin resistance, diabetes, and cardiovascular risk in children: an American Heart Association scientific statement from the Atherosclerosis, Hypertension, and Obesity in the Young Committee (Council on Cardiovascular Disease in the Young) and the Diabetes Committee (Council on Nutrition, Physical Activity, and Metabolism). Circulation. 2003 Mar 18;107(10):1448-53. doi: 10.1161/01.cir.0000060923.07573.f2. No abstract available.
- Teo K, Yusuf S, Sleight P, Anderson C, Mookadam F, Ramos B, Hilbrich L, Pogue J, Schumacher H; ONTARGET/TRANSCEND Investigators. Rationale, design, and baseline characteristics of 2 large, simple, randomized trials evaluating telmisartan, ramipril, and their combination in high-risk patients: the Ongoing Telmisartan Alone and in Combination with Ramipril Global Endpoint Trial/Telmisartan Randomized Assessment Study in ACE Intolerant Subjects with Cardiovascular Disease (ONTARGET/TRANSCEND) trials. Am Heart J. 2004 Jul;148(1):52-61. doi: 10.1016/j.ahj.2004.03.020.
- Yamagishi S, Takeuchi M. Telmisartan is a promising cardiometabolic sartan due to its unique PPAR-gamma-inducing property. Med Hypotheses. 2005;64(3):476-8. doi: 10.1016/j.mehy.2004.09.015.
- Benson SC, Pershadsingh HA, Ho CI, Chittiboyina A, Desai P, Pravenec M, Qi N, Wang J, Avery MA, Kurtz TW. Identification of telmisartan as a unique angiotensin II receptor antagonist with selective PPARgamma-modulating activity. Hypertension. 2004 May;43(5):993-1002. doi: 10.1161/01.HYP.0000123072.34629.57. Epub 2004 Mar 8.
- Derosa G, Ragonesi PD, Mugellini A, Ciccarelli L, Fogari R. Effects of telmisartan compared with eprosartan on blood pressure control, glucose metabolism and lipid profile in hypertensive, type 2 diabetic patients: a randomized, double-blind, placebo-controlled 12-month study. Hypertens Res. 2004 Jul;27(7):457-64. doi: 10.1291/hypres.27.457.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Cardiovascular Diseases
- Vascular Diseases
- Glucose Metabolism Disorders
- Metabolic Diseases
- Hyperinsulinism
- Lipid Metabolism Disorders
- Hypertension
- Dyslipidemias
- Insulin Resistance
- Molecular Mechanisms of Pharmacological Action
- Antihypertensive Agents
- Angiotensin II Type 1 Receptor Blockers
- Angiotensin Receptor Antagonists
- Telmisartan
Other Study ID Numbers
- Telmisartan adolescents
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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