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

• Status: Unknown status
• Trial end date: 2011-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Massachusetts General Hospital
• Treatments: Hormones; Insulin

Criteria

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