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

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ClinicalTrials.gov Identifier: NCT01169103
Recruitment Status : Completed
First Posted : July 23, 2010
Results First Posted : July 21, 2014
Last Update Posted : November 2, 2021
Sponsor:
Collaborator:
Genentech, Inc.
Information provided by (Responsible Party):
Madhusmita Misra, Massachusetts General Hospital

Study Description
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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.

Condition or disease Intervention/treatment Phase
Obesity Drug: recombinant human growth hormone (rhGH) Drug: Placebo Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 22 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Effect of rhGH Administration on Visceral Adiposity and Markers of Cardiovascular Risk in Obese Adolescent Girls: Phase 2
Study Start Date : March 2010
Actual Primary Completion Date : April 2013
Actual Study Completion Date : December 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hormones

Arms and Interventions
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Arm Intervention/treatment
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.


Outcome Measures
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Primary Outcome Measures :
  1. Change in Visceral and Subcutaneous Abdominal Adipose Tissue Over 6 Months [ Time Frame: Baseline and 6 months ]
    Visceral adipose tissue (VAT) and subcutaneous abdominal adipose tissue (SAT) were assessed using single slice MR imaging (MRI)

  2. Changes in Lipid Panel [ Time Frame: Baseline and 6 months ]
    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

  3. Change in High-sensitivity C-reactive Protein (Hs-CRP) Over 6 Months [ Time Frame: Baseline and 6 months ]
    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.

  4. Change in Soluble Intercellular Adhesion Molecule-1 (sICAM) Over 6 Months [ Time Frame: Baseline and 6 months ]
    Soluble intercellular adhesion molecule-1 (sICAM) was used as a surrogate marker of cardiovascular risk


Secondary Outcome Measures :
  1. Change in Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) Score [ Time Frame: Baseline and 6 months ]
    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]


Eligibility Criteria
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Ages Eligible for Study:   13 Years to 21 Years   (Child, Adult)
Sexes 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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01169103


Locations
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United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Massachusetts General Hospital
Genentech, Inc.
Investigators
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Principal Investigator: Madhusmita Misra, MD Massachusetts General Hospital
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Madhusmita Misra, Associate Professor of Pediatrics, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT01169103    
Other Study ID Numbers: 2009P000861
First Posted: July 23, 2010    Key Record Dates
Results First Posted: July 21, 2014
Last Update Posted: November 2, 2021
Last Verified: October 2021
Keywords provided by Madhusmita Misra, Massachusetts General Hospital:
Obesity
Adolescent
Insulin resistance
 Growth hormone
Visceral fat
Adolescent obesity
Additional relevant MeSH terms:
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Obesity
Overnutrition
Nutrition Disorders
Overweight
 Body Weight
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs