Effect of Diazoxide on the Obesity Secondary to Hypothalamic-pituitary Lesions

Sponsor

Assistance Publique - Hôpitaux de Paris (Other)

Overall Status

Completed

CT.gov ID

NCT00306683

Collaborator

(none)

Enrollment

Location

Duration (Months)

1.1

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Hypothalamic-pituitary Lesions Craniopharyngiomas	Drug: DIAZOXIDE	Phase 3

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 : 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

Study Design

Study Type:

Interventional

Actual Enrollment :

40 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

Official Title:

Clinical Assessment of the Treatment With Diazoxide in Children Suffering From Obesity and Hyperinsulinemia Secondary to Surgery of Hypothalamic-pituitary Lesions

Study Start Date :

Apr 1, 2006

Actual Primary Completion Date :

Apr 1, 2009

Actual Study Completion Date :

Apr 1, 2009

Outcome Measures

Primary Outcome Measures

Relative weight change over two months [2 months]
Relative weight change over two months
(Weight at Day 1 - Weight at Day 60)/Weight at Day 1 []

Secondary Outcome Measures

Absolute weight change over two months []
Decrease of hyperinsulinemia []
Decrease of the glucose peak after oral glucose tolerance test (OGTT) []
Evolution of HbA1c []

Eligibility Criteria

Criteria

Ages Eligible for Study:

6 Years to 18 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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 Criteria:

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