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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00306683
Recruitment Status : Completed
First Posted : March 24, 2006
Last Update Posted : February 18, 2011
Sponsor:
Information provided by:
Assistance Publique - Hôpitaux de Paris

Tracking Information
First Submitted Date  ICMJE March 23, 2006
First Posted Date  ICMJE March 24, 2006
Last Update Posted Date February 18, 2011
Study Start Date  ICMJE April 2006
Actual Primary Completion Date April 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 17, 2011)
  • Relative weight change over two months [ Time Frame: 2 months ]
    Relative weight change over two months
  • (Weight at Day 1 - Weight at Day 60)/Weight at Day 1
Original Primary Outcome Measures  ICMJE
 (submitted: March 23, 2006)
  • Relative weight change over two months :
  • (Weight at Day 1 - Weight at Day 60)/Weight at Day 1
Change History Complete list of historical versions of study NCT00306683 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: March 23, 2006)
  • Absolute weight change over two months
  • Decrease of hyperinsulinemia
  • Decrease of the glucose peak after oral glucose tolerance test (OGTT)
  • Evolution of HbA1c
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effect of Diazoxide on the Obesity Secondary to Hypothalamic-pituitary Lesions
Official Title  ICMJE Clinical Assessment of the Treatment With Diazoxide in Children Suffering From Obesity and Hyperinsulinemia Secondary to Surgery of Hypothalamic-pituitary Lesions
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

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE
  • Hypothalamic-pituitary Lesions
  • Craniopharyngiomas
Intervention  ICMJE Drug: DIAZOXIDE
Study Arms  ICMJE Not Provided
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. Epub 2016 Sep 7.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 23, 2006)
40
Original Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE April 2009
Actual Primary Completion Date April 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 6 Years to 18 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00306683
Other Study ID Numbers  ICMJE P040701
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Isabelle BRINDEL, Department of Clinical Research of developpement
Study Sponsor  ICMJE Assistance Publique - Hôpitaux de Paris
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Raja BRAUNER, MD,PhD Assistance Publique - Hôpitaux de Paris
PRS Account Assistance Publique - Hôpitaux de Paris
Verification Date April 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP