Trial record 52 of 2491 for:
hyperinsulinism
Effect of Diazoxide on the Obesity Secondary to Hypothalamic-pituitary Lesions
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| ClinicalTrials.gov Identifier: NCT00306683 |
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Recruitment Status :
Completed
First Posted : March 24, 2006
Last Update Posted : February 18, 2011
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Sponsor:
Assistance Publique - Hôpitaux de Paris
Information provided by:
Assistance Publique - Hôpitaux de Paris
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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
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Hypothalamic-pituitary Lesions Craniopharyngiomas | Drug: DIAZOXIDE | Phase 3 |
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 : | Interventional (Clinical Trial) |
| Actual Enrollment : | 40 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Double (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 |
| Study Start Date : | April 2006 |
| Actual Primary Completion Date : | April 2009 |
| Actual Study Completion Date : | April 2009 |
Resource links provided by the National Library of Medicine
Drug Information available for:
Diazoxide
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
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| Ages Eligible for Study: | 6 Years to 18 Years (Child, Adult) |
| Sexes Eligible for Study: | All |
| 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
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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 |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Isabelle BRINDEL, Department of Clinical Research of developpement |
| ClinicalTrials.gov Identifier: | NCT00306683 History of Changes |
| Other Study ID Numbers: |
P040701 |
| First Posted: | March 24, 2006 Key Record Dates |
| Last Update Posted: | February 18, 2011 |
| Last Verified: | April 2007 |
Keywords provided by Assistance Publique - Hôpitaux de Paris:
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Hypothalamic-pituitary lesions Craniopharyngioma Obesity Diazoxide Hyperinsulinemia |
Pediatric neurosurgery Oncology Pituitary Hypothalamus |
Additional relevant MeSH terms:
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Obesity Pituitary Diseases Craniopharyngioma Adamantinoma Overnutrition Nutrition Disorders Overweight 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 Neoplasms, Nerve Tissue Bone Neoplasms Neoplasms by Site Bone Diseases Musculoskeletal Diseases Diazoxide Antihypertensive Agents Vasodilator Agents |