Clinical Trial: Effect of Diazoxide on the Obesity Secondary to Hypothalamic-pituitary Lesions
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Clinical Assessment of the Treatment With Diazoxide in Children Suffering From Obesity and Hyperinsulinemia Secondary to Surgery of Hypothalamic-pituitary Lesions
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 Summary:
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 : the obesity
This study is performed to optimize the management of the children with hypothalamic-pituitary lesions by reducing the hyperinsulinemia due to the lesion and the surgery
Sponsor: Assistance Publique - Hôpitaux de Paris
Current Primary Outcome:
- Relative weight change over two months [ Time Frame: 2 months ]Relative weight change over two months
- (Weight at Day 1 - Weight at Day 60)/Weight at Day 1
Original Primary Outcome:
- Relative weight change over two months :
- (Weight at Day 1 - Weight at Day 60)/Weight at Day 1
Current Secondary Outcome:
- Absolute weight change over two months
- Decrease of hyperinsulinemia
- Decrease of the glucose peak after oral glucose tolerance test (OGTT)
- Evolution of HbA1c
Original Secondary Outcome: Same as current
Information By: Assistance Publique - Hôpitaux de Paris
Dates:
Date Received: March 23, 2006
Date Started: April 2006
Date Completion:
Last Updated: February 17, 2011
Last Verified: April 2007