Conditions: Obesity
Keywords: Obesity Adolescent Insulin resistance Growth hormone Visceral fat Adolescent obesity
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 22
Healthy volunteers: no

Brief summary:
Teenagers and adults who are overweight or obese have an increase in fat in the abdomen, which increases their risk for diabetes and heart disease. Reducing abdominal fat is important to reduce risk for diabetes and for heart disease. Overweight teenagers also have low levels of growth hormone compared to normal weight teenagers, and teenagers with the lowest growth hormone levels also have the greatest abdominal fat. In children who are unable to make growth hormone for other reasons, giving back growth hormone leads to a decrease in abdominal fat. We are studying whether giving growth hormone in small doses to overweight teenagers can change body composition. We hypothesize that growth hormone will cause abdominal fat to decrease and reduce the risk markers for diabetes and heart disease.

Detailed description:

Arms:
arm 1: Forty subjects will be randomized to receive either recombinant human growth hormone or placebo. arm 2: Forty subjects will be randomized to receive either recombinant human growth hormone or placebo.

Interventions: intervention 1: recombinant human growth hormone (rhGH) intervention 2: Placebo
Intervention descriptions: intervention 1: Initial rhGH dose 0.4mg administered by subcutaneous injection daily. Dose will be increased to 0.6 mg after one week and then increased to 0.8mg after two weeks. intervention 2: Placebo will be administered by daily subcutaneous injections. Sham increases will be used.

Protocol document: