Clinical trial NCT01169103: Effect of Recombinant Human Growth Hormone (rhGH) on Abdominal Fat and Cardiovascular Risk in Obese Girls
Official title: Effect of rhGH Administration on Visceral Adiposity and Markers of Cardiovascular Risk in Obese Adolescent Girls: Phase 2
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Obesity
Keywords: Obesity
Adolescent
Insulin resistance
Growth hormone
Visceral fat
Adolescent obesity
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: Genentech, Inc.
First posted: 2010-07-23
Enrollment: 22
Sex: FEMALE
Minimum age (years): 13
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Change in Visceral and Subcutaneous Abdominal Adipose Tissue Over 6 Months
timeFrame: Baseline and 6 months
measure: Changes in Lipid Panel
timeFrame: Baseline and 6 months
measure: Change in High-sensitivity C-reactive Protein (Hs-CRP) Over 6 Months
timeFrame: Baseline and 6 months
measure: Change in Soluble Intercellular Adhesion Molecule-1 (sICAM) Over 6 Months
timeFrame: Baseline and 6 months
Secondary outcomes:
measure: Change in Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) Score
timeFrame: Baseline and 6 months
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Madhusmita Misra, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.