Status:
COMPLETED
Effect of Diazoxide on the Obesity Secondary to Hypothalamic-pituitary Lesions
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Conditions:
Hypothalamic-pituitary Lesions
Craniopharyngiomas
Eligibility:
All Genders
6-18 years
Phase:
PHASE3
Brief Summary
In children treated for intracranial lesions, the 2 factors of the obesity are : the location of the lesion (hypothalamic-pituitary region) and craniopharyngiomas
Detailed Description
Approximately 80 % of the hypothalamic-pituitary lesions that occur in children are craniopharyngiomas with one or three cases per 1 million children each year. One major problem remains unsolved : t...
Eligibility Criteria
Inclusion
- Age 6 to 18 years
- Obesity with body mass index \> 97 percentile or \> 2 SD
- Hypothalamic-pituitary lesions not evolutive
- Hyperinsulinemia defined by insulin peak after oral glucose tolerance test\>100 UI/L
- Absence of diabetes mellitus defined by basal plasma glucose \< 1.2 g/L and glucose peak after oral glucose tolerance test \< 2 g/L and HbA1c \< 7 %
- Hormonal replacement therapy stable from at least three months excluding the treatment of diabetes insipidus which can be adjusted
- Normal plasma thyroxine
- Written informed consent of the children and the parents
Exclusion
- evolutive lesion
- recent surgery or radiotherapy (\< 6 months)
- modification of hormonal replacement therapy during the three previous months
- diabetes mellitus defined by basal plasma glucose \> 1.2 g/L and glucose peak after oral glucose tolerance test \> 2 g/L and HbA1c \> 7 %
- renal or hepatic failure
- uncontrolled hypertension
- hypersensitivity to benzothiazine drugs
- pregnancy
- difficulties to understand the protocol
Key Trial Info
Start Date :
April 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2009
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT00306683
Start Date
April 1 2006
End Date
April 1 2009
Last Update
February 18 2011
Active Locations (1)
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1
Hopital Kremlin-Bicetre
Paris, France, 94275