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