Hypothalamic-pituitary Lesions, Craniopharyngiomas
Conditions
Keywords
Hypothalamic-pituitary lesions, Craniopharyngioma, Obesity, Diazoxide, Hyperinsulinemia, Pediatric neurosurgery, Oncology, Pituitary, Hypothalamus
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
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
Interventions
DRUGDIAZOXIDE
Sponsors
Assistance Publique - Hôpitaux de Paris
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
6 Years to 18 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Relative weight change over two months | 2 months | Relative weight change over two months |
| (Weight at Day 1 - Weight at Day 60)/Weight at Day 1 | — | — |
Secondary
| Measure | Time frame |
|---|---|
| Absolute weight change over two months | — |
| Decrease of hyperinsulinemia | — |
| Decrease of the glucose peak after oral glucose tolerance test (OGTT) | — |
| Evolution of HbA1c | — |
Countries
France
Outcome results
None listed