Effect of Diazoxide on the Obesity Secondary to Hypothalamic-pituitary Lesions
This study has been completed.
Sponsor:
Assistance Publique - Hôpitaux de Paris
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
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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) |
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
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:
|
Craniopharyngioma Adamantinoma Hyperinsulinism Obesity Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Neoplasms by Histologic Type Neoplasms Neoplasms, Nerve Tissue Bone Neoplasms Neoplasms by Site Bone Diseases Musculoskeletal Diseases |
Glucose Metabolism Disorders Metabolic Diseases Overnutrition Nutrition Disorders Overweight Body Weight Signs and Symptoms Diazoxide Antihypertensive Agents Cardiovascular Agents Therapeutic Uses Pharmacologic Actions Vasodilator Agents |
ClinicalTrials.gov processed this record on May 22, 2013