NCT00306683

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Apr 2006

Typical duration for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 23, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 24, 2006

Completed
8 days until next milestone

Study Start

First participant enrolled

April 1, 2006

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2009

Completed
Last Updated

February 18, 2011

Status Verified

April 1, 2007

Enrollment Period

3 years

First QC Date

March 23, 2006

Last Update Submit

February 17, 2011

Conditions

Hypothalamic-pituitary LesionsCraniopharyngiomas

Keywords

Hypothalamic-pituitary lesionsCraniopharyngiomaObesityDiazoxideHyperinsulinemiaPediatric neurosurgeryOncologyPituitaryHypothalamus

Outcome Measures

Primary Outcomes (2)

  • Relative weight change over two months

    Relative weight change over two months

    2 months

  • (Weight at Day 1 - Weight at Day 60)/Weight at Day 1

Secondary Outcomes (4)

  • Absolute weight change over two months

  • Decrease of hyperinsulinemia

  • Decrease of the glucose peak after oral glucose tolerance test (OGTT)

  • Evolution of HbA1c

Interventions

DIAZOXIDEDRUG

Eligibility Criteria

Age6 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hopital Kremlin-Bicetre

Paris, 94275, France

Location

Related Publications (1)

  • 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.

    PMID: 27603903DERIVED

MeSH Terms

Conditions

CraniopharyngiomaObesityHyperinsulinismNeoplasmsPituitary Diseases

Interventions

Diazoxide

Condition Hierarchy (Ancestors)

Neuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasms, Nerve TissueOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsGlucose Metabolism DisordersMetabolic DiseasesHypothalamic DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

BenzothiadiazinesSulfonamidesSulfonesSulfur CompoundsOrganic ChemicalsThiazidesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Raja BRAUNER, MD,PhD

    Assistance Publique - Hôpitaux de Paris

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 23, 2006

First Posted

March 24, 2006

Study Start

April 1, 2006

Primary Completion

April 1, 2009

Study Completion

April 1, 2009

Last Updated

February 18, 2011

Record last verified: 2007-04

Locations

FR(1)