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

NCT ID: NCT01169103

Last Updated: 2021-11-02

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

22 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-03-31

Study Completion Date

2014-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Obesity

Keywords

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Obesity Adolescent Insulin resistance Growth hormone Visceral fat Adolescent obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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recombinant human growth hormone

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

Group Type EXPERIMENTAL

recombinant human growth hormone (rhGH)

Intervention Type 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

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

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

Interventions

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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.

Intervention Type DRUG

Placebo

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

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

13 Years

Maximum Eligible Age

21 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Genentech, Inc.

INDUSTRY

Sponsor Role collaborator

Massachusetts General Hospital

OTHER

Sponsor Role lead

Responsible Party

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Madhusmita Misra

Associate Professor of Pediatrics

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Madhusmita Misra, MD

Role: PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital

Locations

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Massachusetts General Hospital

Boston, Massachusetts, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 25435886 (View on PubMed)

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.

Reference Type DERIVED
PMID: 24251951 (View on PubMed)

Other Identifiers

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2009P000861

Identifier Type: -

Identifier Source: org_study_id