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

• Status: Completed
• Trial end date: 2009-04-01
• Target enrollment: 0
• Participant gender: All

Summary

In children treated for intracranial lesions, the 2 factors of the obesity are : the location of the lesion (hypothalamic-pituitary region) and craniopharyngiomas

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Assistance Publique - Hôpitaux de Paris
• Treatments: Diazoxide

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