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Effect of Diazoxide on the Obesity Secondary to Hypothalamic-pituitary Lesions | Clinical Trials | Clareo Health

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

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

NCT00306683•Assistance Publique - Hôpitaux de Paris

View on ClinicalTrials.gov

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

Age

6 - 18 years

Sex

ALL

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

Locations (1)

Hopital Kremlin-Bicetre

Paris, France

Key Dates

Start Date

April 1, 2006

Primary Completion Date

April 1, 2009

Completion Date

April 1, 2009

Last Updated

February 18, 2011

Enrollment

ACTUAL participants

Conditions

Hypothalamic-pituitary LesionsCraniopharyngiomas

Interventions

DIAZOXIDE

DRUG

Safety and Efficacy of Anlotinib in the Treatment of Recurrent Craniopharyngioma

NCT06970145

Craniopharyngiomas

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 18, 2011Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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