Clinical trial NCT01828931: Lifestyle Intervention for Diabetes and Weight Management in Psychosis
Official title: Effectiveness of Intensive Lifestyle Interventions in the Management of Diabetes in Individuals With Psychosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 2 Diabetes Mellitus
Schizophrenia
Schizoaffective Disorder
Schizophreniform Disorder
Bipolar I Disorder
Substance-induced Psychosis
Psychotic Disorders
Major Depressive Disorder
Lead sponsor: Centre for Addiction and Mental Health
Sponsor class: OTHER
Collaborators: name: Canadian Diabetes Association
First posted: 2013-04-11
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 years less than the general population, primarily due to premature onset of cardiovascular disease (CVD). Despite the high risk for T2DM and CVD, psychotic illness has been an exclusion criterion in all large-scale studies of diabetes prevention and management. We propose a 3-year randomized controlled trial examining the effectiveness of a lifestyle intervention (LI) aimed at reducing caloric intake and increasing physical activity in overweight or obese individuals (N=150) suffering from both a psychotic illness and T2DM. Weight and glycemic control will be the primary outcome variables. It is hypothesized that a significant weight reduction and improvement in glycemic control will be found in those who receive the LI relative to those who do not.


Eligibility criteria: Inclusion Criteria:

1. Between the ages of 18 and 70 years (inclusive)
2. DSM-IV-TR diagnosis of one of the psychotic disorders listed above
3. Body Mass Index (BMI) \> 25 kg/m2 at the time of enrollment
4. Clearly documented diagnosis of type-2 diabetes mellitus or prediabetes
5. Ability to provide informed consent
6. No medical contraindication to participation in weight reduction / exercise program, determined in consultation with their primary care physician
7. Female participants, of childbearing potential, using a medically accepted means of contraception

Exclusion Criteria:

1. Inability to give informed consent
2. Currently enrolled in a formal structured weight management program
3. Currently being prescribed medication specifically for weight loss
4. Participants with unstable or active cardiovascular illnesses (myocardial infarction, CHF, etc), active or end-stage renal disease, unstable thyroid disease, etc.
5. Recurrent episodes of diabetic ketoacidosis, seizure or coma without warning or severe hypoglycemia

Primary outcomes:
measure: Weight
timeFrame: 52 weeks
measure: HbA1c levels
timeFrame: 52 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Centre for Addiction and Mental Health
state: Ontario
Study officials:
affiliation: Centre for Addiction and Mental Health
name: Margaret K Hahn, M.D.
role: PRINCIPAL_INVESTIGATOR
References: