Insulin Resistance Clinical Trial
Official title:
Metabolic Effect of Metformin in Obese Insulin Resistant Adolescents With Normal Glucose Tolerance
The primary objective of this randomized, parallel group, double-blind, placebo-controlled study is to determine whether treatment with metformin enhances insulin sensitivity in a group of ethnically diverse obese insulin-resistant adolescents with normal glucose tolerance.
Status | Completed |
Enrollment | 28 |
Est. completion date | December 2007 |
Est. primary completion date | December 2007 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 13 Years to 17 Years |
Eligibility |
Inclusion Criteria: - Attending weight management clinic at Yale New Haven Hospital - Good general health, taking no other medication on a chronic basis - Age 13 to 17 yrs in puberty (girls: breast Tanner stage II to IV, and boys: testes size > 6 ml) - The presence of insulin resistance, defined by fasting insulin levels greater than 30 µU/ml, and HOMA insulin resistance index > 6 - Normal glucose tolerance based on a 2-hr plasma glucose (<140 mg/dl) after the OGTT. - All female subjects must have a negative urine pregnancy test during the study visits and must use an effective method of contraception if they are sexually active. Without their parent(s) present, all potential female subjects will be asked about their sexual activity and the specific form of contraception they are using. Exclusion Criteria: - Baseline creatinine > 1.0 mg/dl - Hepatic disease with elevated liver function test (ALT or AST) = 2 X the upper limits of normal - Pregnancy - Presence of other endocrinopathies; except treated hypothyroidism on stable replacement doses of thyroid hormone - Presence of cardiac, pulmonary or other significant chronic illness - Adolescents with psychiatric disorder, claustrophobia or with substance abuse - Recent use (within six months) of anorexic agents - Presence of anemia (hematocrit < 35) - Mixed ethnic background (defined as two parents of different ethnicity) - Adolescents with metal implants (i.e. cardiac pace maker, metal prostheses, bullet remnants) |
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Yale Center for Clinical Investigation (YCCI) | New Haven | Connecticut |
Lead Sponsor | Collaborator |
---|---|
Yale University | National Institutes of Health (NIH) |
United States,
Burgert TS, Duran EJ, Goldberg-Gell R, Dziura J, Yeckel CW, Katz S, Tamborlane WV, Caprio S. Short-term metabolic and cardiovascular effects of metformin in markedly obese adolescents with normal glucose tolerance. Pediatr Diabetes. 2008 Dec;9(6):567-76. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Assessment of insulin sensitivity: Whole Body Insulin Sensitivity Index (WBISI), Homeostasis Model Assessment of Insulin Resistance (HOMA-IR), and Euglycemic hyperinsulinemic clamp | Baseline (month 0), post 3-month intervention (month 4), and post 6-month extension (month 10). | Yes | |
Secondary | Body mass index (BMI) | Baseline (month 0), post 3-month intervention (month 4), and post 6-month extension (month 10). | No | |
Secondary | Waist to hip circumference ratio | Baseline (month 0), post 3-month intervention (month 4), and post 6-month extension (month 10). | No | |
Secondary | Muscle lipid content | Baseline (month 0), post 3-month intervention (month 4), and post 6-month extension (month 10). | No | |
Secondary | Total body fat | Baseline (month 0), post 3-month intervention (month 4), and post 6-month extension (month 10). | No | |
Secondary | Abdominal fat mass | Baseline (month 0), post 3-month intervention (month 4), and post 6-month extension (month 10). | No | |
Secondary | Hepatic fat fraction | Baseline (month 0), post 3-month intervention (month 4), and post 6-month extension (month 10). | No | |
Secondary | Hepatic iron concentration | Baseline (month 0), post 3-month intervention (month 4), and post 6-month extension (month 10). | No | |
Secondary | Plasma ghrelin levels | Baseline (month 0), post 3-month intervention (month 4), and post 6-month extension (month 10). | No | |
Secondary | Adiponectin levels | Baseline (month 0), post 3-month intervention (month 4), and post 6-month extension (month 10). | No | |
Secondary | Leptin levels | Baseline (month 0), post 3-month intervention (month 4), and post 6-month extension (month 10). | No | |
Secondary | Blood pressure | Baseline (month 0), post 3-month intervention (month 4), and post 6-month extension (month 10). | No | |
Secondary | Lipid profile | Baseline (month 0), post 3-month intervention (month 4), and post 6-month extension (month 10). | No | |
Secondary | Microalbuminuria | Baseline (month 0), post 3-month intervention (month 4), and post 6-month extension (month 10). | No | |
Secondary | Inflammatory markers (Plasminogen activator inhibitor-1 (PAI-1), C-reactive protein (CRP), homocysteine, tumor necrosis factor (TNF)-a, Interleukin (IL)-6) | Baseline (month 0), post 3-month intervention (month 4), and post 6-month extension (month 10). | No | |
Secondary | Self-paced step test (Heart rate recovery after exercise) | Baseline (month 0), post 3-month intervention (month 4), and post 6-month extension (month 10). | No | |
Secondary | Peripheral Arterial Tonometry (PAT) | Baseline (month 0), post 3-month intervention (month 4), and post 6-month extension (month 10). | No | |
Secondary | Females only: Markers of polycystic ovarian syndrome (PCOS) - Adrenal androgens (17 Hydroxyprogesterone, Dehydroepiandrosterone), sex hormone binding globulin (SHBG), free testosterone, LH/FSH ratio | Baseline (month 0), post 3-month intervention (month 4), and post 6-month extension (month 10). | No | |
Secondary | Females only: Menstrual pattern | Throughout study | No | |
Secondary | Ethnic stratification (Hispanic, African American or Caucasian) | Baseline (month 0) | No |
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