Clinical trial · Interventional
Effect of Diazoxide on the Obesity Secondary to Hypothalamic-pituitary Lesions
Clinical Assessment of the Treatment With Diazoxide in Children Suffering From Obesity and Hyperinsulinemia Secondary to Surgery of Hypothalamic-pituitary Lesions
NCT00306683CI-TRIAL-00004437completedPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
In children treated for intracranial lesions, the 2 factors of the obesity are : the location of the lesion (hypothalamic-pituitary region) and craniopharyngiomas
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Craniopharyngiomas | Craniopharyngioma | ALIAS | 0.90 |
| Hypothalamic-pituitary Lesions | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| DIAZOXIDE | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (2)
- measure
- Relative weight change over two months
- timeFrame
- 2 months
- description
- Relative weight change over two months
- measure
- (Weight at Day 1 - Weight at Day 60)/Weight at Day 1
Secondary outcomes (4)
- measure
- Absolute weight change over two months
- measure
- Decrease of hyperinsulinemia
- measure
- Decrease of the glucose peak after oral glucose tolerance test (OGTT)
- measure
- Evolution of HbA1c
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 6 Years
- Maximum age
- 18 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDBrauner 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. doi: 10.1210/jc.2016-2126. Epub 2016 Sep 7. PMID 27603903