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NCT Number: NCT01169103

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

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.

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Key information

Conditions

Obesity Body Weight Glucose Metabolism Disorders Hyperinsulinism Insulin Resistance Metabolic Diseases Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Pediatric Obesity Signs and Symptoms

Age range

13 year–21 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

recombinant human growth hormone (rhGH)

Drug

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

Drug

Placebo will be administered by daily subcutaneous injections. Sham increases will be used.

Primary outcomes

  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 outcomes

  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]

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Collaborators

  • Genentech, Inc.

Registry information

Official study title

Effect of rhGH Administration on Visceral Adiposity and Markers of Cardiovascular Risk in Obese Adolescent Girls: Phase 2

Important dates

Study start
2010
Primary completion
2013
Study completion
2014
First posted
Jul 23, 2010
Registry last updated
Nov 2, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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