Clinical trial NCT00306683: Effect of Diazoxide on the Obesity Secondary to Hypothalamic-pituitary Lesions
Official title: Clinical Assessment of the Treatment With Diazoxide in Children Suffering From Obesity and Hyperinsulinemia Secondary to Surgery of Hypothalamic-pituitary Lesions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hypothalamic-pituitary Lesions
Craniopharyngiomas
Keywords: Hypothalamic-pituitary lesions
Craniopharyngioma
Obesity
Diazoxide
Hyperinsulinemia
Pediatric neurosurgery
Oncology
Pituitary
Hypothalamus
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2006-03-24
Enrollment: 40
Sex: ALL
Minimum age (years): 6
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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

Eligibility criteria: 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

Primary outcomes:
measure: Relative weight change over two months
timeFrame: 2 months
measure: (Weight at Day 1 - Weight at Day 60)/Weight at Day 1
Secondary outcomes:
measure: Absolute weight change over two months
measure: Decrease of hyperinsulinemia
measure: Decrease of the glucose peak after oral glucose tolerance test (OGTT)
measure: Evolution of HbA1c
Other outcomes:
Locations:
city: Paris
country: France
facility: Hopital Kremlin-Bicetre
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: Raja BRAUNER, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Brauner R, Serreau R, Souberbielle JC, Pouillot M, Grouazel S, Recasens C, Zerah M, Sainte-Rose C, Treluyer JM. Diazoxide in Children With Obesity After Hypothalamic-Pituitary Lesions: A Randomized, Placebo-Controlled Trial. J Clin Endocrinol Metab. 2016 Dec;101(12):4825-4833. doi: 10.1210/jc.2016-2126. Epub 2016 Sep 7.