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Study to Identify Markers of Insulin Resistance During Growth Hormone Treatment for Short Stature

NCT00121875 · Status: TERMINATED · Type: OBSERVATIONAL · Enrollment: 1

Last updated 2009-09-29

No results posted yet for this study

Summary

Growth hormone treatment improves body fat distribution but also causes insulin resistance. Scientists have recently linked insulin resistance with special stores of fat in the muscles, which can be measured by magnetic resonance imaging (MRI). The researchers hypothesize that growth hormone will paradoxically reverse the linkage between muscle fat stores and insulin resistance. To assess this association and to investigate the cause(s), the researchers will measure muscle fat stores during growth hormone treatment. Other parameters linked to insulin resistance (glucose tolerance, blood markers, and body composition) will also be assessed. This study may lead to improved strategies for monitoring growth hormone therapy.

Conditions

  • Turner Syndrome
  • Idiopathic Short Stature

Interventions

DRUG

somatropin (rDNA)

Form/Strength: 10 mg aqueous suspension; 5 mg/ml Dosage/Frequency: 0.35 mg/kg/week, daily divided doses Duration: 6 months with 3-month washout period

Sponsors & Collaborators

  • Massachusetts General Hospital

    lead OTHER

Principal Investigators

  • Lynne L Levitsky, MD · Massachusetts General Hospital

Eligibility

Min Age
7 Years
Max Age
14 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-06-30
Completion
2008-12-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00121875 on ClinicalTrials.gov