Status:
COMPLETED
Hypothalamic Obesity Following Craniopharyngioma Surgery: A Pilot Trial of Combined Metformin and Diazoxide Therapy
Lead Sponsor:
The Hospital for Sick Children
Conditions:
Hypothalamic Obesity
Eligibility:
All Genders
9-22 years
Phase:
PHASE2
Brief Summary
To study the effect of combined diazoxide-metformin therapy on body weight in youth with hypothalamic obesity following treatment for craniopharyngioma. A secondary objective is to evaluate changes in...
Detailed Description
46 children under the age of 22 years have been treated surgically for craniopharyngioma tumor and are currently followed at the Hospital for Sick Children, Toronto. Approximately 50% are obese (BMI ≥...
Eligibility Criteria
Inclusion
- Craniopharyngioma at least one year following surgery
- Evidence of at least one other endocrinopathy of hypothalamic origin
- Stable hormone replacement therapy (with one or more of thyroxine hydrocortisone, DDAVP, sex steroids and GH)
- Obesity, defined as weight \>120% Ideal Body Weight (IBW) or BMI \> 27 kg/m2, with normal weight for height before tumour diagnosis and weight gain \>2SD above mean for age for 1 year following tumour treatment (41).
- Age 9 -22 years
- Minimum of 6 months of standard diet and exercise intervention (run-in period). This was chosen to allow a period of prospective measurements to establish individual baseline slope of change in BMI SDS prior to initiation of active treatment with diazoxide and metformin.
Exclusion
- Contraindications for Metformin or Diazoxide use (history or evidence of cardiac, renal, or progressive hepatic disease , diabetes or hypoxic conditions)
- Pharmacologic doses of glucocorticoids or use of other medications known to affect glucose metabolism (e.g. beta-blockers, oral hypoglycemics)
- Growth hormone (GH) initiation in the preceding 6 months or planned initiation in the next 6 months (to rule out potential confounding effect of GH on weight / body composition and glucose metabolism).
- Use of other weight loss medications
- Inability of the family and/or patient to comply with study protocol
- Non English speaking
Key Trial Info
Start Date :
May 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2008
Estimated Enrollment :
9 Patients enrolled
Trial Details
Trial ID
NCT00892073
Start Date
May 1 2006
End Date
January 1 2008
Last Update
November 17 2017
Active Locations (1)
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1
The Hospital for Sick Children
Toronto, Ontario, Canada