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

NCT01169103 | Completed Phase 2 Results DMC

• 1 other identifier: 2009P000861
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity

Keywords

Obesity; Adolescent; Insulin resistance; Growth hormone; Visceral fat; Adolescent obesity

Outcome Measures

Primary Outcomes (4)

• Change in Visceral and Subcutaneous Abdominal Adipose Tissue Over 6 Months

  Visceral adipose tissue (VAT) and subcutaneous abdominal adipose tissue (SAT) were assessed using single slice MR imaging (MRI)

  Baseline and 6 months

• Changes in Lipid Panel

  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

  Baseline and 6 months

• Change in High-sensitivity C-reactive Protein (Hs-CRP) Over 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.

  Baseline and 6 months

• Change in Soluble Intercellular Adhesion Molecule-1 (sICAM) Over 6 Months

  Soluble intercellular adhesion molecule-1 (sICAM) was used as a surrogate marker of cardiovascular risk

  Baseline and 6 months

Secondary Outcomes (1)

• Change in Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) Score

  Baseline and 6 months

Study Arms (2)

recombinant human growth hormone

EXPERIMENTAL

Forty subjects will be randomized to receive either recombinant human growth hormone or placebo.

Drug: recombinant human growth hormone (rhGH)

Placebo

PLACEBO COMPARATOR

Forty subjects will be randomized to receive either recombinant human growth hormone or placebo.

Drug: Placebo

Interventions

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.

recombinant human growth hormone

Placebo DRUG

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

Placebo

Eligibility Criteria

• Age: 13 Years - 21 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• Genentech, Inc.: collaborator

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Related Publications (2)

• Slattery M, Bredella MA, Stanley T, Torriani M, Misra M. Effects of recombinant human growth hormone (rhGH) administration on body composition and cardiovascular risk factors in obese adolescent girls. Int J Pediatr Endocrinol. 2014;2014(1):22. doi: 10.1186/1687-9856-2014-22. Epub 2014 Nov 15.

  PMID: 25435886 DERIVED

• 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.

  PMID: 24251951 DERIVED

MeSH Terms

Conditions

Obesity; Insulin Resistance; Pediatric Obesity

Interventions

Growth Hormone

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases

Intervention Hierarchy (Ancestors)

Pituitary Hormones, Anterior; Pituitary Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Results Point of Contact

• Title: Madhusmita Misra
• Organization: Massachusetts General Hospital

mmisra@partners.org

617-724-5602

Study Officials

• Madhusmita Misra, MD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Pediatrics

Study Record Dates

• First Submitted: July 22, 2010
• First Posted: July 23, 2010
• Study Start: March 1, 2010
• Primary Completion: April 1, 2013
• Study Completion: December 1, 2014
• Last Updated: November 2, 2021
• Results First Posted: July 21, 2014

Record last verified: 2021-10

Locations

US (1)