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Completed

NCT Number: NCT00306683

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

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

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Key information

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Diazoxide

Drug

Primary outcomes

  1. Relative weight change over two months

    Time frame: 2 months

    Relative weight change over two months

  2. (Weight at Day 1 - Weight at Day 60)/Weight at Day 1

Secondary outcomes

  1. Absolute weight change over two months

  2. Decrease of hyperinsulinemia

  3. Decrease of the glucose peak after oral glucose tolerance test (OGTT)

  4. Evolution of HbA1c

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Registry information

Official study title

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

Important dates

Study start
2006
Primary completion
2009
Study completion
2009
First posted
Mar 24, 2006
Registry last updated
Feb 18, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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