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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-04-30

Study Completion Date

2009-04-30

Brief Summary

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

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Detailed Description

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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

Conditions

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Hypothalamic-pituitary Lesions Craniopharyngiomas

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Interventions

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DIAZOXIDE

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

6 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No