Effect of rhGH on Visceral Adiposity and Cardiovascular Risk in Obese Girls
| Status: | Completed |
|---|---|
| Conditions: | Obesity Weight Loss |
| Therapuetic Areas: | Endocrinology |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 10/21/2012 |
| Start Date: | March 2010 |
| End Date: | December 2014 |
| Contact: | Madhusmita Misra, MD |
| Email: | mmisra@partners.org |
| Phone: | 617-726-3870 |
Effect of rhGH Administration on Visceral Adiposity and Markers of Cardiovascular Risk in Obese Adolescent Girls: Phase 2
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.
Inclusion Criteria:
- Adolescent girls 13-21 years old with bone age ≥ 14 years
- Overweight girls: BMI greater than the 95th percentile for age
- Waist/Hip ratio ≥ 0.85
- IGF-1 below -0.5 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
We found this trial at
1
site
Click here to add this to my saved trials
