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Study to Examine Insulin Resistance During Growth Hormone Treatment for Short Stature Due to Low Birthweight

NCT00120497 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 12

Last updated 2011-07-20

No results posted yet for this study

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

Interventions

DRUG

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

Sponsors & Collaborators

  • Massachusetts General Hospital

    lead OTHER

Principal Investigators

  • Lynne L Levitsky, MD · Massachusetts General Hospital

Eligibility

Min Age
8 Years
Max Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-07-31
Primary Completion
2011-07-31
Completion
2011-12-31

Countries

  • United States

Study Locations

More Related Trials

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 NCT00120497 on ClinicalTrials.gov