Diabetes Prevention Program in Schizophrenia [DPPS]

Schizophrenia Clinical Trial

Official title: A Five Year, Prospective, Randomized, Blinded, Controlled Trial Comparing the Efficacy of a Modified Diabetes Prevention Protocol and the Standard Comprehensive Outpatient Care in Lowering the Incidence of New Onset Diabetes Among People Treated for Schizophrenia and Are at Risk to Develop Type II Diabetes Mellitus.

Status Recruiting

Clinical Trial Summary

Diabetes is 2-5 times more common in schizophrenia and it is a preventable; but the current diabetes prevention guidelines are not suitable for implementation in the severely mentally ill population. The principles of diabetes prevention are essentially dietary regulation, increased physical activity and adjunctive use of oral anti-diabetic drugs (metformin). In a modified diabetes prevention protocol suitable for use in mentally ill population, we packaged the original guide lines with an adventure and recreation program based on principles of experiential learning, cognitive restructuring and behaviour modification. In this proposed study, we plan to evaluate the feasibility of adopting the new protocol, and examine its effectiveness in preventing diabetes.

Clinical Trial Description

Rationale:

• From large international RCT studies, Type 2 Diabetes can be prevented / delayed for overweight, pre-diabetic individuals by making basic lifestyle changes (regular moderate exercise, healthy eating habits) and using metformin or other insulin resistance inhibitor.

• Individuals with schizophrenia are in particular need of preventative intervention and conventional approaches do not match their needs.

• Research has not examined how to facilitate lifestyle changes in the lives of individuals with schizophrenia.

We need to…

• Develop and evaluate innovative diabetes prevention strategies tailored to meet the needs of individuals with schizophrenia.

• Research how to make it work for pre-diabetic individuals being treated for schizophrenia.

The effectiveness of the novel intervention will be tested using a prospective, randomized, controlled clinical trial. A multi-factorial design enables a 2 x 2 analysis of the independent effects of three interventions – a tailored lifestyle modification program, metformin, and the standard conventional intervention. There is no anticipated interaction effect between metformin and lifestyle interventions. Clients currently treated for schizophrenia at a community outpatient clinic will be screened for diabetes, and those who fulfill the inclusion criteria, and give written consent, following a three week run-in period, will be randomized to one of four groups to receive either: the experimental intervention with placebo, the experimental intervention with metformin or the conventional intervention with placebo or conventional intervention with metformin. ;

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Diabetes Mellitus
• Schizophrenia

• NCT number: NCT00182494
• Study type: Interventional
• Source: McMaster University
• Contact: Lakshmi P Voruganti, MD
• Phone: 905-522-1155
• Email: vorugl@mcmaster.ca
• Status: Recruiting
• Phase: Phase 4
• Start date: February 2005
• Completion date: January 2009