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

Study Overview
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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

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

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

Conditions
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Hypothalamic-pituitary Lesions, Craniopharyngiomas

Intervention / Treatment
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* Drug: DIAZOXIDE


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: DIAZOXIDE|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Relative weight change over two months | Relative weight change over two months | 2 months | 
| (Weight at Day 1 - Weight at Day 60)/Weight at Day 1 |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Absolute weight change over two months |  |  | 
| Decrease of hyperinsulinemia |  |  | 
| Decrease of the glucose peak after oral glucose tolerance test (OGTT) |  |  | 
| Evolution of HbA1c |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hypothalamic-pituitary lesions, Craniopharyngioma, Obesity, Diazoxide, Hyperinsulinemia, Pediatric neurosurgery, Oncology, Pituitary, Hypothalamus