Diabetes Prevention Program in Schizophrenia [DPPS]
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00182494|
Recruitment Status : Unknown
Verified July 2005 by McMaster University.
Recruitment status was: Recruiting
First Posted : September 16, 2005
Last Update Posted : September 16, 2005
|Condition or disease||Intervention/treatment||Phase|
|Diabetes Mellitus Schizophrenia||Behavioral: Modified diabetes prevention protocol & Metformin||Phase 4|
- 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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||200 participants|
|Intervention Model:||Parallel Assignment|
|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.|
|Study Start Date :||February 2005|
|Estimated Study Completion Date :||January 2009|
- 1. Adherence/ability to run as designed /recruitment
- 2. Impact on modifiable diabetes risk factors
- 3. Impact on incidence of diabetes
- 1. Adherence Rates for Diet, Exercise, Meds
- 2. Changes in lifestyle, Changes in eating patterns, Changes in activity patterns
- 3. Sustained changes in eating & activity patterns
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00182494
|Contact: Lakshmi P Voruganti, MD||905-522-1155 ext firstname.lastname@example.org|
|Contact: Susan Strong, MScemail@example.com|
|Hamilton, Ontario, Canada|
|Contact: Lakshmi P Voruganti, MD 905-522-1155 ext 6355 firstname.lastname@example.org|
|Contact: Susan Strong, MSc 905 522 1155 email@example.com|
|Principal Investigator: Lakshmi P Voruganti, MD|
|Principal Investigator:||Lakshmi P Voruganti, MD||McMaster University|