Recruiting

Growth Hormone

Sponsor:

Massachusetts General Hospital

Code:

NCT00120497

Conditions

Fetal Growth Retardation

Eligibility Criteria

Sex: All

Age: 8 - 12

Healthy Volunteers: Not accepted

Interventions

somatropin (rDNA)

Study Details

Brief summary:

Insulin resistance is common among children with low birthweight. Moreover, growth hormone treatment for ensuing short stature also causes insulin resistance. Our objective is to examine these processes. Insulin resistance has recently been linked to the accumulation of stores of fat in muscle cells which can be measured by MRI. We hypothesize that children who are short due to low birthweight have increased muscle fat stores, but that growth hormone treatment will paradoxically reverse this association. To test this hypothesis, muscle fat stores will be measured in children who are short due to low birthweight before and after receiving growth hormone therapy. Other parameters linked to insulin resistance (glucose tolerance, blood markers, and body composition) will also be assessed. This study may lead to ways to increase growth hormone safety and dose limitations.

Conditions

Fetal Growth Retardation

Study ID

NCT00120497

Start date

Jul, 2005

Status verified date

Jul, 2011

Completion date

Dec, 2011

Anticipated

Primary completion date

Jul, 2011

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 8 - 12

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • height < 5%-ile
  • birthweight < 10%-ile for gestational age
  • gestation: ≥ 36 weeks
  • male or female
  • age: 8-12 years
  • BMI = 10-90%-ile
  • normal childhood activity, no physical or other limitations
  • bone age ≤ 12 years
  • normal, balanced diet (20-40% calories from fat)

Exclusion Criteria:

  • puberty (beyond Tanner Stage 1)
  • diabetes in subject or first degree relative
  • sex steroid therapy
  • chronic conditions requiring medication
  • other causes of short stature (e.g., Prader-Willi, intracranial lesions, hypopituitarism, Turner syndrome, GHD, etc.)
  • significant systemic disease (pulmonary, cardiac, renal, or other)
  • non-removable metal
  • other conditions judged by the investigator to pose a hazard (including history of neoplasm)
  • simultaneous participation in another medical investigation or trial

Study Design

Enrollment

12 participants

Anticipated

Interventions and Outcome Measures

Interventions

somatropin (rDNA)

Dosage form/strength: 13.8 mg powder in 2-chamber cartridge; reconstitutes to 10 mg/ml

Dosage regimen: 0.48 mg/kg/week

Route/rate of administration: subcutaneous injection, daily dose

Central Contacts and Locations

Central contacts

Lynne L Levitsky, MD

617-726-2909llevitsky@partners.org

David B Rhoads, PhD

617-724-2707rhoads@helix.mgh.harvard.edu

Locations

Massachusetts General Hospital

Recruiting

Boston, Massachusetts, United States, 02114

Contacts

David B Rhoads, PhD

617-724-2707rhoads@helix.mgh.harvard.edu

More Information

Sponsor

Massachusetts General Hospital

Last update posted

Jul 20, 2011

Last verified

Jul, 2011

Keywords

  • short stature
  • intrauterine growth restriction
  • insulin resistance
  • intramyocellular lipid
  • small for gestational age
  • glucose tolerance

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Massachusetts General Hospital on 2011-07-20.