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

Assistance Publique - Hôpitaux de Paris

Status and phase

Completed

Phase 3

Conditions

Craniopharyngiomas

Hypothalamic-pituitary Lesions

Treatments

Drug: DIAZOXIDE

Study type

Interventional

Funder types

Other

Identifiers

NCT00306683

P040701

Details and patient eligibility

About

In children treated for intracranial lesions, the 2 factors of the obesity are : the location of the lesion (hypothalamic-pituitary region) and craniopharyngiomas

Full 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

Enrollment

40 patients

Sex

All

Ages

6 to 18 years old

Volunteers

No 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