Effect of Recombinant Human Growth Hormone (rhGH) on Abdominal Fat and Cardiovascular Risk in Obese Girls
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.
Timeline
- Start
- 2010-03
- Primary completion
- 2013-04
- Completion
- 2014-12
Outcome
Mixed primary results
registry MEAN Recombinant Human Growth Hormone: -22.2 (Standard Deviation 30.3) ng/mL NCT01169103 ↗
registry MEAN Placebo/no Treatment: 21.1 (Standard Deviation 33.3) ng/mL NCT01169103 ↗
registry analysis (unspecified test); Recombinant Human Growth Hormone vs Placebo/no Treatment; p = 0.04; t-test, 2 sided NCT01169103 ↗
registry analysis (unspecified test); Recombinant Human Growth Hormone vs Placebo/no Treatment; p = 0.70; t-test, 2 sided NCT01169103 ↗
Publications
- Slattery M, Bredella MA, Stanley T, Torriani M, Misra M. Effects of recombinant human growth hormone (rhGH) administration on body composition and cardiovascular risk factors in obese adolescent girls. Int J Pediatr Endocrinol. 2014;2014(1):22. doi: 10.1186/1687-9856-2014-22. Epub 2014 Nov 15.
- Slattery MJ, Bredella MA, Thakur H, Torriani M, Misra M. Insulin resistance and impaired mitochondrial function in obese adolescent girls. Metab Syndr Relat Disord. 2014 Feb;12(1):56-61. doi: 10.1089/met.2013.0100. Epub 2013 Nov 19.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Somatropin | Protein / enzyme biologic | 0.8 mg | Subcutaneous |