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

This study has been completed.
Sponsor:
Information provided by:
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT00306683
First received: March 23, 2006
Last updated: February 17, 2011
Last verified: April 2007
  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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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 ] [ Designated as safety issue: Yes ]
    Relative weight change over two months

  • (Weight at Day 1 - Weight at Day 60)/Weight at Day 1 [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Absolute weight change over two months [ Designated as safety issue: Yes ]
  • Decrease of hyperinsulinemia [ Designated as safety issue: Yes ]
  • Decrease of the glucose peak after oral glucose tolerance test (OGTT) [ Designated as safety issue: Yes ]
  • Evolution of HbA1c [ Designated as safety issue: Yes ]

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

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

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

No publications provided

Responsible Party: Isabelle BRINDEL, Department of Clinical Research of developpement
ClinicalTrials.gov Identifier: NCT00306683     History of Changes
Other Study ID Numbers: P040701
Study First Received: March 23, 2006
Last Updated: February 17, 2011
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:
Adamantinoma
Craniopharyngioma
Obesity
Body Weight
Bone Diseases
Bone Neoplasms
Musculoskeletal Diseases
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Germ Cell and Embryonal
Neoplasms, Nerve Tissue
Neuroectodermal Tumors
Nutrition Disorders
Overnutrition
Overweight
Signs and Symptoms
Diazoxide
Antihypertensive Agents
Cardiovascular Agents
Pharmacologic Actions
Therapeutic Uses
Vasodilator Agents

ClinicalTrials.gov processed this record on October 21, 2014