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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Genentech, Inc.
Information provided by (Responsible Party):
Madhusmita Misra, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT01169103
First received: July 22, 2010
Last updated: July 18, 2014
Last verified: July 2014

July 22, 2010
July 18, 2014
March 2010
April 2013   (final data collection date for primary outcome measure)
  • Change in Visceral and Subcutaneous Abdominal Adipose Tissue Over 6 Months [ Time Frame: Baseline and 6 months ] [ Designated as safety issue: No ]
    Visceral adipose tissue (VAT) and subcutaneous abdominal adipose tissue (SAT) were assessed using single slice MR imaging (MRI)
  • Changes in Lipid Panel [ Time Frame: Baseline and 6 months ] [ Designated as safety issue: No ]
    Lipid profile will be obtained using established methods. Total Cholesterol, Triglycerides, LDL and HDL measurements will be obtained at baseline, and then at the six-month visits to determine the rate at which lipid measures change with rhGH therapy
  • Change in High-sensitivity C-reactive Protein (Hs-CRP) Over 6 Months [ Time Frame: Baseline and 6 months ] [ Designated as safety issue: No ]
    As a marker of cardiovascular risk, hs-CRP will be assessed at baseline and 6 months to assess the rate at which hs-CRP levels change with rhGH therapy.
  • Change in Soluble Intercellular Adhesion Molecule-1 (sICAM) Over 6 Months [ Time Frame: Baseline and 6 months ] [ Designated as safety issue: No ]
    Soluble intercellular adhesion molecule-1 (sICAM) was used as a surrogate marker of cardiovascular risk
Change in visceral adipose tissue and markers of cardiovascular risk. [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01169103 on ClinicalTrials.gov Archive Site
Change in Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) Score [ Time Frame: Baseline and 6 months ] [ Designated as safety issue: Yes ]
Homeostasis model assessment of insulin resistance (HOMA-IR) was used as a validated measure of insulin resistance. A 2-hour Oral Glucose Tolerance Test (OGTT) using 1.75 gram/kilogram of oral glucose (maximum 75 gram) will be performed at baseline and six months after administration of rhGH/placebo/ no therapy. Fasting insulin and glucose will be used to determine HOMA-IR: [fasting glucose (mmol/l) x fasting insulin (µU/ml)]/22.5]
Change in homeostasis model assessment of insulin resistance (HOMA-IR) indicating insulin resistance. [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Effect of Recombinant Human Growth Hormone (rhGH) on Abdominal Fat and Cardiovascular Risk in Obese Girls
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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Obesity
  • Drug: recombinant human growth hormone (rhGH)
    Initial rhGH dose 0.4mg administered by subcutaneous injection daily. Dose will be increased to 0.6 mg after one week and then increased to 0.8mg after two weeks.
  • Drug: Placebo
    Placebo will be administered by daily subcutaneous injections. Sham increases will be used.
  • Experimental: recombinant human growth hormone
    Forty subjects will be randomized to receive either recombinant human growth hormone or placebo.
    Intervention: Drug: recombinant human growth hormone (rhGH)
  • Placebo Comparator: Placebo
    Forty subjects will be randomized to receive either recombinant human growth hormone or placebo.
    Intervention: Drug: Placebo
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
22
December 2014
April 2013   (final data collection date for primary outcome measure)

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
Female
13 Years to 21 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01169103
2009P000861
Yes
Madhusmita Misra, Massachusetts General Hospital
Massachusetts General Hospital
Genentech, Inc.
Principal Investigator: Madhusmita Misra, MD Massachusetts General Hospital
Massachusetts General Hospital
July 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP