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
  Purpose

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.


Condition Intervention Phase
Obesity
Drug: recombinant human growth hormone (rhGH)
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Effect of rhGH Administration on Visceral Adiposity and Markers of Cardiovascular Risk in Obese Adolescent Girls: Phase 2

Resource links provided by NLM:


Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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]


Enrollment: 22
Study Start Date: March 2010
Estimated Study Completion Date: December 2014
Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: recombinant human growth hormone
Forty subjects will be randomized to receive either recombinant human growth hormone or placebo.
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.
Placebo Comparator: Placebo
Forty subjects will be randomized to receive either recombinant human growth hormone or placebo.
Drug: Placebo
Placebo will be administered by daily subcutaneous injections. Sham increases will be used.

  Eligibility

Ages Eligible for Study:   13 Years to 21 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01169103

Locations
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Massachusetts General Hospital
Genentech, Inc.
Investigators
Principal Investigator: Madhusmita Misra, MD Massachusetts General Hospital
  More Information

No publications provided by Massachusetts General Hospital

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Madhusmita Misra, Associate Professor of Pediatrics, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT01169103     History of Changes
Other Study ID Numbers: 2009P000861
Study First Received: July 22, 2010
Results First Received: December 10, 2013
Last Updated: July 18, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Massachusetts General Hospital:
Obesity
Adolescent
Insulin resistance
Growth hormone
Visceral fat
Adolescent obesity

Additional relevant MeSH terms:
Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on October 16, 2014