Obesity Clinical Trial
Official title:
Effects of Metformin on Energy Intake, Energy Expenditure, and Body Weight in Overweight Children With Insulin Resistance
This study will examine the safety and effectiveness of the medicine metformin to help
overweight children control their food intake, weight, insulin, cholesterol, and
triglyceride (blood fat) levels. Obesity and high insulin levels can lead to high blood
pressure, diabetes, high cholesterol and triglyceride levels and heart disease.
Metformin-approved by the Food and Drug Administration to treat adults with type 2 diabetes
mellitus-helps lower insulin levels and may control weight gain in adults.
Overweight children 6 to 11 years old who are in general good health may be eligible for
this study. Children will be studied at the National Institutes of Health in Bethesda,
Maryland. Candidates will have a medical history and physical examination and fasting blood
test, and will provide a 7-day record of their food intake as part of the screening process.
Those enrolled will be randomly assigned to receive either metformin or placebo (a
look-alike tablet with no active medicine) twice a day for a six month period. After the 6
month study period, all children will be offered the opportunity to take metformin for
another 6 months.
Participants will be hospitalized for 2-3 days for the following procedures: history and
physical examination; fasting blood test; several urine collections; X-ray studies to
determine bone age and amount of body fat and muscle; magnetic resonance imaging (MRI) scan
to measure body fat; "hyperglycemic clamp study" to evaluate insulin resistance; food intake
testing; nutrition consultation; resting metabolic rate; and a "doubly labeled water" test.
For the hyperglycemic clamp study, a catheter (thin flexible tube) is inserted into a vein
in each arm. A sugar solution is given through one tube and blood samples are drawn every 5
minutes through the other to measure insulin. For the food intake testing, the child is
asked about his or her hunger level, then given various foods he or she may choose to eat,
then questioned again at various intervals both during and after finishing eating about his
or her hunger level. The doubly labeled water study involves drinking "heavy water" (water
which is enriched to have special kinds of hydrogen and oxygen). Urine specimens are
collected 2, 3 and 4 hours after drinking the water. The child also drinks a special milk
shake called a Scandishake and repeats the calorie intake and hunger study. (Two food intake
studies are done on separate days.) One week after the heavy water test, additional urine
samples are collected one week later.
After completing the tests, the child will begin treatment with metformin or placebo, plus a
daily vitamin tablet. Participants will be followed once a month with a brief history and
physical examination, including a blood test. After 6 months, all of the tests described
above will be repeated. All children who complete the second round of tests-both those who
took metformin and those who took placebo-will be offered metformin for an additional 6
months and will be seen once a month for follow-up evaluations. Parents will not be told
which children received metformin and which received placebo until all children in the study
complete the first 6 months of the trial.
The prevalence of overweight and obesity in children and adolescents in the United States has doubled during the past 20 years. Obesity is closely linked with development of insulin resistance and other mediators of unfavorable cardiovascular risk, such as hypertension and dyslipidemia. These obesity-related risk factors often first appear during childhood. Since obese children tend to become obese adults, such children are at increased risk for persistence of these abnormalities into adulthood and for the early occurrence of obesity-related morbidity and mortality. Obesity-related insulin resistance is also largely responsible for the recently documented rise in the incidence of Type 2 diabetes in youth. To date, there is no FDA-approved pharmacotherapy for children with obesity and insulin resistance. Metformin is a medication approved for use in adults with Type 2 diabetes that is unique in that it promotes weight loss and improves features of the insulin resistance syndrome. Preliminary studies suggest that metformin may promote weight loss in obese non-diabetic children. However, the mechanism of metformin-induced weight loss has not been elucidated. We propose to evaluate the safety, tolerability, efficacy and mechanism of metformin-induced weight loss in obese, hyperinsulinemic children aged 6-12.99 years. We will conduct a six-month randomized, double blind placebo-controlled trial of metformin. All study participants will receive nutritional consultation and advice on appropriate diet. We will study the effects of metformin on weight, food intake, energy expenditure, insulin sensitivity, and lipids. At the end of the six-month placebo-controlled trial, all subjects will be offered metformin in an open label phase for an additional six months. ;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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