Study to Examine Insulin Resistance During Growth Hormone Treatment for Short Stature Due to Low Birthweight
Status unconfirmed
Conditions studied: Fetal Growth Retardation
In brief
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.
Key facts
- Study ID
- NCT00120497
- Run by
- Massachusetts General Hospital
- People needed
- 12
- Starts
- 2005-07-01
- Expected to finish
- 2011-12-01
- Last updated by the study team
- 2011-07-20
Who can join
Age: 8 and older, up to 12. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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)
You may not qualify if…
- 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
Where it is running
- Massachusetts General Hospital — Boston, Massachusetts, United States (enrolling)
Full record on ClinicalTrials.gov
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