Ignite Creation Date:
2024-05-05 @ 11:57 AM
Last Modification Date:
2024-10-26 @ 9:16 AM
Study NCT ID:
NCT00182494
Status:
UNKNOWN
Last Update Posted:
2005-09-16
First Post:
2005-09-14
Brief Title:
Diabetes Prevention Program in Schizophrenia DPPS
Sponsor:
Hamilton Health Sciences Corporation
Organization:
McMaster University
Study Overview
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:
UNKNOWN
Status Verified Date:
2005-07
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
Detailed 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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None