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

February 17, 2011 updated by: Assistance Publique - Hôpitaux de Paris

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Drug: DIAZOXIDE

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

Study Type

Interventional

Enrollment (Actual)

Phase

Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

France
- - Paris, France, 94275
    - Hôpital Kremlin-Bicêtre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 years to 18 years (ADULT, CHILD)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: TREATMENT
Allocation: RANDOMIZED
Interventional Model: PARALLEL
Masking: DOUBLE

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Relative weight change over two months Time Frame: 2 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
Absolute weight change over two months
Decrease of hyperinsulinemia
Decrease of the glucose peak after oral glucose tolerance test (OGTT)
Evolution of HbA1c

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assistance Publique - Hôpitaux de Paris

Investigators

Principal Investigator: Raja BRAUNER, MD,PhD, Assistance Publique - Hôpitaux de Paris

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2006

Primary Completion (ACTUAL)

April 1, 2009

Study Completion (ACTUAL)

April 1, 2009

Study Registration Dates

First Submitted

March 23, 2006

First Submitted That Met QC Criteria