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

This study is currently recruiting participants.

Verified by Assistance Publique - Hôpitaux de Paris, April 2007

First Received: March 23, 2006 Last Updated: April 13, 2007 History of Changes

Sponsor:	Assistance Publique - Hôpitaux de Paris
Collaborator:	French Health Products Safety Agency
Information provided by:	Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:	NCT00306683

Purpose

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

Condition	Intervention	Phase
Hypothalamic-Pituitary Lesions Craniopharyngiomas	Drug: DIAZOXIDE	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Clinical Assessment of the Treatment With Diazoxide in Children Suffering From Obesity and Hyperinsulinemia Secondary to Surgery of Hypothalamic-Pituitary Lesions

Resource links provided by NLM:

MedlinePlus related topics: Obesity Obesity in Children

Drug Information available for: Diazoxide

U.S. FDA Resources

Further study details as provided by Assistance Publique - Hôpitaux de Paris:

Primary Outcome Measures:

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

Estimated Enrollment:	40
Study Start Date:	April 2006
Estimated Study Completion Date:	February 2008

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

Ages Eligible for Study:	6 Years to 18 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00306683

Contacts

Contact: Raja BRAUNER, MD, PhD

+33(0)-45 21 32 19

raja.brauner@bct.aphp.fr

Locations

France
HOPITAL KREMLIN-BICETRE, Service Endocrinologie Pédiatrique	Recruiting
PARIS, France, 94275
Contact: Raja BRAUNER, MD,PhD +33(0)-1 45 21 32 19 raja.brauner@bct.aphp.fr

Sponsors and Collaborators

Assistance Publique - Hôpitaux de Paris

French Health Products Safety Agency

Investigators

Principal Investigator:

Raja BRAUNER, MD,PhD

Assistance Publique - Hôpitaux de Paris

More Information

No publications provided

Study ID Numbers:	P040701
Study First Received:	March 23, 2006
Last Updated:	April 13, 2007
ClinicalTrials.gov Identifier:	NCT00306683 History of Changes
Health Authority:	France: Ministry of Health

Keywords provided by Assistance Publique - Hôpitaux de Paris:

Hypothalamic-pituitary lesions
Craniopharyngioma
Obesity
Diazoxide
Hyperinsulinemia

Pediatric neurosurgery
Oncology
Pituitary
Hypothalamus

Additional relevant MeSH terms:

Obesity
Vasodilator Agents
Neoplasms by Histologic Type
Metabolic Diseases
Diazoxide
Neoplasms, Nerve Tissue
Overweight
Cardiovascular Agents
Antihypertensive Agents
Pharmacologic Actions
Body Weight

Signs and Symptoms
Hyperinsulinism
Neuroectodermal Tumors
Neoplasms
Therapeutic Uses
Neoplasms, Germ Cell and Embryonal
Craniopharyngioma
Nutrition Disorders
Overnutrition
Glucose Metabolism Disorders

ClinicalTrials.gov processed this record on November 20, 2009