Phase 2
N=22
Effect of Recombinant Human Growth Hormone (rhGH) on Abdominal Fat and Cardiovascular Risk in Obese Girls
Obesity
Bottom Line
View on ClinicalTrials.gov: NCT01169103 ↗Enrolled (actual)
22
Serious AEs
0.0%
Results posted
Jul 2014
Primary outcome: Primary: Change in Visceral and Subcutaneous Abdominal Adipose Tissue Over 6 Months — 57; 799; -111; 3634 mm^2 — p=0.70
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- recombinant human growth hormone (rhGH) (Drug); Placebo (Drug)
- Age
- Pediatric, Adult · 13+ yrs
- Sex
- Female
- Sponsor
- Massachusetts General Hospital
- Primary completion
- Apr 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Visceral and Subcutaneous Abdominal Adipose Tissue Over 6 Months |
57; 799; -111; 3634 | 0.70 |
| PRIMARY Changes in Lipid Panel |
-37.8; -8.6; -27.8; 6.1; -25.8; -10.7 | 0.03 sig |
| PRIMARY Change in High-sensitivity C-reactive Protein (Hs-CRP) Over 6 Months |
-0.77; -0.09 | 0.58 |
| PRIMARY Change in Soluble Intercellular Adhesion Molecule-1 (sICAM) Over 6 Months |
-22.2; 21.1 | 0.04 sig |
| SECONDARY Change in Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) Score |
-0.52; -2.92 | 0.93 |
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
Data sourced from ClinicalTrials.gov (NCT01169103). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.