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

This study has been completed.
Information provided by:
Assistance Publique - Hôpitaux de Paris Identifier:
First received: March 23, 2006
Last updated: February 17, 2011
Last verified: April 2007
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
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Investigator)
Primary Purpose: Treatment
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:

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

Primary Outcome Measures:
  • 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

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

Enrollment: 40
Study Start Date: April 2006
Study Completion Date: April 2009
Primary Completion Date: April 2009 (Final data collection date for primary outcome measure)
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


Ages Eligible for Study:   6 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
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Please refer to this study by its identifier: NCT00306683

Hopital Kremlin-Bicetre
Paris, France, 94275
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Principal Investigator: Raja BRAUNER, MD,PhD Assistance Publique - Hôpitaux de Paris
  More Information

Responsible Party: Isabelle BRINDEL, Department of Clinical Research of developpement Identifier: NCT00306683     History of Changes
Other Study ID Numbers: P040701
Study First Received: March 23, 2006
Last Updated: February 17, 2011

Keywords provided by Assistance Publique - Hôpitaux de Paris:
Hypothalamic-pituitary lesions
Pediatric neurosurgery

Additional relevant MeSH terms:
Pituitary Diseases
Nutrition Disorders
Body Weight
Signs and Symptoms
Hypothalamic Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Endocrine System Diseases
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Nerve Tissue
Bone Neoplasms
Neoplasms by Site
Bone Diseases
Musculoskeletal Diseases
Antihypertensive Agents
Vasodilator Agents processed this record on April 25, 2017