Status:
UNKNOWN
Study to Examine Insulin Resistance During Growth Hormone Treatment for Short Stature Due to Low Birthweight
Lead Sponsor:
Massachusetts General Hospital
Conditions:
Fetal Growth Retardation
Eligibility:
All Genders
8-12 years
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 process...
Detailed Description
Growth hormone (GH) is an effective height-enhancing treatment for short stature. One underlying disorder is intrauterine growth restriction (IUGR). Increased growth enhances quality of life as well a...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 1 2005
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 1 2011
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT00120497
Start Date
July 1 2005
End Date
December 1 2011
Last Update
July 20 2011
Active Locations (1)
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1
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114