Status:
TERMINATED
Study to Identify Markers of Insulin Resistance During Growth Hormone Treatment for Short Stature
Lead Sponsor:
Massachusetts General Hospital
Conditions:
Turner Syndrome
Idiopathic Short Stature
Eligibility:
FEMALE
7-14 years
Brief 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 m...
Detailed Description
Growth hormone (GH) treatment can cause insulin resistance (IR) despite its overall favorable influence on body fat composition. IR is associated with special stores of fat in the muscle (intramyocell...
Eligibility Criteria
Inclusion
- Girls, with Turner syndrome or ISS; height standard deviation score (SDS) ≤ -2
- Bone age ≤ 12 years
- Normal birthweight
- Body mass index (BMI) = 10th-90th percentile
- Normal childhood activity; no physical or other limitations
- 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 (treatment for hypothyroidism is permissible)
- Significant systemic disease (pulmonary, cardiac, renal, or other)
- Non-removable metal
Key Trial Info
Start Date :
June 1 2005
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 1 2008
Estimated Enrollment :
1 Patients enrolled
Trial Details
Trial ID
NCT00121875
Start Date
June 1 2005
End Date
December 1 2008
Last Update
September 29 2009
Active Locations (1)
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1
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114