Hypothalamic Obesity Clinical Trial
Official title:
Combined Diazoxide and Metformin Therapy in Children With Hypothalamic Obesity Secondary to Craniopharyngioma: A Pilot Study
Verified date | November 2017 |
Source | The Hospital for Sick Children |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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 insulin resistance (IR), beta-cell function, features of the metabolic
syndrome, muscle metabolism and intramyocellular lipid.
Hypothesis: Treatment with diazoxide and metformin will result in weight loss or slowed
weight gain and improved metabolic profile, compared to pretreatment levels.
Status | Completed |
Enrollment | 9 |
Est. completion date | January 2008 |
Est. primary completion date | January 2008 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 9 Years to 22 Years |
Eligibility |
Inclusion Criteria: - 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 Criteria: - 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 |
Country | Name | City | State |
---|---|---|---|
Canada | The Hospital for Sick Children | Toronto | Ontario |
Lead Sponsor | Collaborator |
---|---|
The Hospital for Sick Children |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in BMI and BMI SDS (calculated using for Disease Control formula - www.cdc.gov.doc) over 6 months of treatment compared to change in BMI and BMI SDS over 6 month 'run-in' period (prior to study start) | 6 months prior to baseline, Baseline, 6 months after baseline | ||
Secondary | Insulin secretion | Baseline to 6 months | ||
Secondary | Insulin resistance | Baseline to 6 months | ||
Secondary | Lipid profile | Baseline to 6 months | ||
Secondary | Adiponectin | Baseline to 6 months | ||
Secondary | Leptin | Baseline to 6 months | ||
Secondary | Features of the metabolic syndrome | Baseline to 6 months |
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