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Clinical Assessment of the Treatment With Diazoxide in Children Suffering From Obesity and Hyperinsulinemia Secondary to Surgery of Hypothalamic-pituitary Lesions


Phase 3
6 Years
18 Years
Not Enrolling
Both
Hypothalamic-pituitary Lesions, Craniopharyngiomas

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Trial Information

Clinical Assessment of the Treatment With Diazoxide in Children Suffering From Obesity and Hyperinsulinemia Secondary to Surgery of Hypothalamic-pituitary Lesions


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


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Outcome Measure:

Relative weight change over two months

Outcome Description:

Relative weight change over two months

Outcome Time Frame:

2 months

Safety Issue:

Yes

Principal Investigator

Raja BRAUNER, MD,PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Assistance Publique - Hôpitaux de Paris

Authority:

France: Ministry of Health

Study ID:

P040701

NCT ID:

NCT00306683

Start Date:

April 2006

Completion Date:

April 2009

Related Keywords:

  • Hypothalamic-pituitary Lesions
  • Craniopharyngiomas
  • Hypothalamic-pituitary lesions
  • Craniopharyngioma
  • Obesity
  • Diazoxide
  • Hyperinsulinemia
  • Pediatric neurosurgery
  • Oncology
  • Pituitary
  • Hypothalamus
  • Craniopharyngioma
  • Adamantinoma
  • Hyperinsulinism
  • Obesity

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