Effect of Recombinant Human Growth Hormone (rhGH) on Abdominal Fat and Cardiovascular Risk in Obese Girls

Mass General Brigham

Status and phase: Completed; Phase 2

Conditions: Obesity

Treatments: Drug: Placebo; Drug: recombinant human growth hormone (rhGH)

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01169103

2009P000861

Details and patient eligibility

About

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.

Enrollment: 22 patients

Sex: Female

Ages: 13 to 21 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adolescent girls 13-21 years old with bone age ≥ 14 years
• Overweight girls: Body Mass Index (BMI) greater than the 95th percentile for age
• Waist/Hip ratio ≥ 0.85
• Insulin Like Growth Factor -1 (IGF-1) below -0.5 standard deviations (SD) for pubertal stage or age

Exclusion criteria

• Pregnancy (positive pregnancy test) prior to enrollment in the study
• Significant weight gain or loss within 3 months of study (more than 5 kg)
• Use of medications that affect GH or cortisol levels (such as estrogen including oral contraceptive pills, oral glucocorticoids)
• Use of medications such as Meridian and Orlistat
• Presence of diabetes mellitus
• Uncontrolled Thyroid disorders
• Chronic renal insufficiency
• Participation in another simultaneous medical investigation or trial
• Active neoplasm or history of cancer
• Prader-Willi syndrome
• History of scoliosis if bone age is <15 years
• Hypersensitivity to rhGH or constituents of the injections

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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22 participants in 2 patient groups, including a placebo group

recombinant human growth hormone

Experimental group

Description:

Forty subjects will be randomized to receive either recombinant human growth hormone or placebo.

Treatment:

Drug: recombinant human growth hormone (rhGH)

Placebo

Placebo Comparator group

Description:

Forty subjects will be randomized to receive either recombinant human growth hormone or placebo.

Treatment:

Drug: Placebo