NCT01828931

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable type-2-diabetes-mellitus

Timeline
Completed

Started Dec 2012

Typical duration for not_applicable type-2-diabetes-mellitus

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2012

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

April 9, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 11, 2013

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2015

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2015

Completed
Last Updated

June 17, 2016

Status Verified

June 1, 2016

Enrollment Period

2.4 years

First QC Date

April 9, 2013

Last Update Submit

June 15, 2016

Conditions

Type 2 Diabetes MellitusSchizophreniaSchizoaffective DisorderSchizophreniform DisorderBipolar I DisorderSubstance-induced PsychosisPsychotic DisordersMajor Depressive Disorder

Outcome Measures

Primary Outcomes (2)

  • Weight

    52 weeks

  • HbA1c levels

    52 weeks

Study Arms (2)

Usual Care

ACTIVE COMPARATOR

Standard care provided via participants' family physicians, diabetes nurses, and psychiatrists.

Other: Usual Care

Lifestyle Intervention

EXPERIMENTAL

A lifestyle intervention based on the Look AHEAD study intervention, involving counselling related to dietary and physical activity habits.

Behavioral: Lifestyle Intervention

Interventions

Lifestyle InterventionBEHAVIORAL

A lifestyle intervention (LI) aimed at reducing caloric intake and increasing physical activity

Lifestyle Intervention
Usual CareOTHER

Care as usual

Usual Care

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre for Addiction and Mental Health

Toronto, Ontario, M6J 1H4, Canada

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2SchizophreniaPsychotic DisordersDepressive Disorder, Major

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesSchizophrenia Spectrum and Other Psychotic DisordersMental DisordersDepressive DisorderMood Disorders

Study Officials

  • Margaret K Hahn, M.D.

    Centre for Addiction and Mental Health

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Staff Psychiatrist

Study Record Dates

First Submitted

April 9, 2013

First Posted

April 11, 2013

Study Start

December 1, 2012

Primary Completion

May 1, 2015

Study Completion

November 1, 2015

Last Updated

June 17, 2016

Record last verified: 2016-06

Locations

CA(1)