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

Primary Purpose

Hypothalamic-pituitary Lesions, Craniopharyngiomas

Status
Completed
Phase
Phase 3
Locations
France
Study Type
Interventional
Intervention
DIAZOXIDE
Sponsored by
Assistance Publique - Hôpitaux de Paris
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypothalamic-pituitary Lesions focused on measuring Hypothalamic-pituitary lesions, Craniopharyngioma, Obesity, Diazoxide, Hyperinsulinemia, Pediatric neurosurgery, Oncology, Pituitary, Hypothalamus

Eligibility Criteria

6 Years - 18 Years (Child, Adult)All SexesDoes not accept 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

Sites / Locations

  • Hopital Kremlin-Bicetre

Outcomes

Primary Outcome Measures

Relative weight change over two months
Relative weight change over two months
(Weight at Day 1 - Weight at Day 60)/Weight at Day 1

Secondary Outcome Measures

Absolute weight change over two months
Decrease of hyperinsulinemia
Decrease of the glucose peak after oral glucose tolerance test (OGTT)
Evolution of HbA1c

Full Information

First Posted
March 23, 2006
Last Updated
February 17, 2011
Sponsor
Assistance Publique - Hôpitaux de Paris
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1. Study Identification

Unique Protocol Identification Number
NCT00306683
Brief Title
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

2. Study Status

Record Verification Date
April 2007
Overall Recruitment Status
Completed
Study Start Date
April 2006 (undefined)
Primary Completion Date
April 2009 (Actual)
Study Completion Date
April 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Assistance Publique - Hôpitaux de Paris

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypothalamic-pituitary Lesions, Craniopharyngiomas
Keywords
Hypothalamic-pituitary lesions, Craniopharyngioma, Obesity, Diazoxide, Hyperinsulinemia, Pediatric neurosurgery, Oncology, Pituitary, Hypothalamus

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
DIAZOXIDE
Primary Outcome Measure Information:
Title
Relative weight change over two months
Description
Relative weight change over two months
Time Frame
2 months
Title
(Weight at Day 1 - Weight at Day 60)/Weight at Day 1
Secondary Outcome Measure Information:
Title
Absolute weight change over two months
Title
Decrease of hyperinsulinemia
Title
Decrease of the glucose peak after oral glucose tolerance test (OGTT)
Title
Evolution of HbA1c

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Raja BRAUNER, MD,PhD
Organizational Affiliation
Assistance Publique - Hôpitaux de Paris
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hopital Kremlin-Bicetre
City
Paris
ZIP/Postal Code
94275
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
27603903
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.
Results Reference
derived

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

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