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

Craniopharyngiomas Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00306683
• Other study ID #: P040701
• Status: Completed
• Phase: Phase 3
• First received: March 23, 2006
• Last updated: February 17, 2011
• Start date: April 2006
• Est. completion date: April 2009

Study information

• Verified date: April 2007
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: April 2009
• Est. primary completion date: April 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Years to 18 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Craniopharyngioma
• Craniopharyngiomas
• Hypothalamic-pituitary Lesions
• Pituitary Diseases

Intervention

Drug:
• DIAZOXIDE

Locations

Country	Name	City	State
France	Hopital Kremlin-Bicetre	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Relative weight change over two months	Relative weight change over two months	2 months	Yes
Primary	(Weight at Day 1 - Weight at Day 60)/Weight at Day 1			Yes
Secondary	Absolute weight change over two months			Yes
Secondary	Decrease of hyperinsulinemia			Yes
Secondary	Decrease of the glucose peak after oral glucose tolerance test (OGTT)			Yes
Secondary	Evolution of HbA1c			Yes