Status:
COMPLETED
Lifestyle Intervention for Diabetes and Weight Management in Psychosis
Lead Sponsor:
Centre for Addiction and Mental Health
Collaborating Sponsors:
Canadian Diabetes Association
Conditions:
Type 2 Diabetes Mellitus
Schizophrenia
Eligibility:
All Genders
18-70 years
Phase:
NA
Brief Summary
The rate of type-2 diabetes mellitus (T2DM) is at least 2-3 times higher in persons with psychotic illnesses than in the general population. Life expectancy of individuals with psychosis is also 20-25...
Eligibility Criteria
Inclusion
- Between the ages of 18 and 70 years (inclusive)
- DSM-IV-TR diagnosis of one of the psychotic disorders listed above
- Body Mass Index (BMI) \> 25 kg/m2 at the time of enrollment
- Clearly documented diagnosis of type-2 diabetes mellitus or prediabetes
- Ability to provide informed consent
- No medical contraindication to participation in weight reduction / exercise program, determined in consultation with their primary care physician
- Female participants, of childbearing potential, using a medically accepted means of contraception
Exclusion
- Inability to give informed consent
- Currently enrolled in a formal structured weight management program
- Currently being prescribed medication specifically for weight loss
- Participants with unstable or active cardiovascular illnesses (myocardial infarction, CHF, etc), active or end-stage renal disease, unstable thyroid disease, etc.
- Recurrent episodes of diabetic ketoacidosis, seizure or coma without warning or severe hypoglycemia
Key Trial Info
Start Date :
December 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2015
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT01828931
Start Date
December 1 2012
End Date
November 1 2015
Last Update
June 17 2016
Active Locations (1)
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1
Centre for Addiction and Mental Health
Toronto, Ontario, Canada, M6J 1H4