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Diabetes Prevention Program in Schizophrenia [DPPS]

Primary Purpose

Diabetes Mellitus, Schizophrenia

Status
Unknown status
Phase
Phase 4
Locations
Canada
Study Type
Interventional
Intervention
Modified diabetes prevention protocol & Metformin
Sponsored by
Hamilton Health Sciences Corporation
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional prevention trial for Diabetes Mellitus focused on measuring Schizophrenia, Diabetes, Weight gain, Antipsychotic drugs

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: People who are at least 18 years old, diagnosed as having schizophrenia, confirmed through a structured clinical interview (SCID-P) for DSM IV, treated with antipsychotic drugs at least for 2 years and deemed clinically stable. Clinical stability is operationally defined as absence of a relapse warranting hospitalization in the preceding six months. People who are deemed as "pre-diabetics" in accordance with the diagnostic criteria established by the American Diabetic Association (ADA, 2004) as following: impaired fasting glucose (IFG) indicating fasting plasma glucose ranging between 100-125 mg/dl or 5.6 - 6.9 mmol/l.; and impaired glucose tolerance (IGT) indicating 2-h post-load glucose ranging between 140-199 mg/dl or 7.8 - 11.0 mmol/l. People who have gained > 10% body weight since??? Or body mass index > 24 kg/m², except Asian decent at 22 kg/m² or greater?? Competent to provide informed consent to voluntarily participate in the study. Exclusion Criteria: People who meet the criteria for diabetes, (i.e., repeat fasting blood glucose (FBG) >7 mmol/l or, 2 hr. post-load glucose >11.1 mmol. as determined by a 2 hr. glucose tolerance test (GTT)). People with evidence of clinically significant liver disease, renal or gastrointestinal impairments, as suggested by clinical history and liver and kidney functions tests. Any impairment deemed clinically significant would be a relative contra-indication for the use of metformin. Women in the child bearing age, who are not willing to use contraceptive measures. People with other comorbid disorders such as clinically significant heart or lung disease that may prevent participation in various physical activities or disorders of glucose metabolism (e.g., Cushing's Syndrome, Acromegaly, and chronic pancreatitis). People with treatments that would interfere with participation or completion of the protocol (e.g., in shared care and planning to be discharged shortly from the clinic), or having a confounding effect on the measurement of the primary outcomes of the study (prescription weight loss drugs, lipid lowering agents?) People with weight loss >10% in past 6 months

Sites / Locations

  • McMaster UniversityRecruiting

Outcomes

Primary Outcome Measures

1. Adherence/ability to run as designed /recruitment
2. Impact on modifiable diabetes risk factors
3. Impact on incidence of diabetes

Secondary Outcome Measures

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

Full Information

First Posted
September 14, 2005
Last Updated
September 14, 2005
Sponsor
Hamilton Health Sciences Corporation
Collaborators
The Lawson Foundation, Ontario Mental Health Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT00182494
Brief Title
Diabetes Prevention Program in Schizophrenia [DPPS]
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 Type
Interventional

2. Study Status

Record Verification Date
July 2005
Overall Recruitment Status
Unknown status
Study Start Date
February 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
January 2009 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Hamilton Health Sciences Corporation
Collaborators
The Lawson Foundation, Ontario Mental Health Foundation

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Schizophrenia
Keywords
Schizophrenia, Diabetes, Weight gain, Antipsychotic drugs

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
200 (false)

8. Arms, Groups, and Interventions

Intervention Type
Behavioral
Intervention Name(s)
Modified diabetes prevention protocol & Metformin
Primary Outcome Measure Information:
Title
1. Adherence/ability to run as designed /recruitment
Title
2. Impact on modifiable diabetes risk factors
Title
3. Impact on incidence of diabetes
Secondary Outcome Measure Information:
Title
1. Adherence Rates for Diet, Exercise, Meds
Title
2. Changes in lifestyle, Changes in eating patterns, Changes in activity patterns
Title
3. Sustained changes in eating & activity patterns

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: People who are at least 18 years old, diagnosed as having schizophrenia, confirmed through a structured clinical interview (SCID-P) for DSM IV, treated with antipsychotic drugs at least for 2 years and deemed clinically stable. Clinical stability is operationally defined as absence of a relapse warranting hospitalization in the preceding six months. People who are deemed as "pre-diabetics" in accordance with the diagnostic criteria established by the American Diabetic Association (ADA, 2004) as following: impaired fasting glucose (IFG) indicating fasting plasma glucose ranging between 100-125 mg/dl or 5.6 - 6.9 mmol/l.; and impaired glucose tolerance (IGT) indicating 2-h post-load glucose ranging between 140-199 mg/dl or 7.8 - 11.0 mmol/l. People who have gained > 10% body weight since??? Or body mass index > 24 kg/m², except Asian decent at 22 kg/m² or greater?? Competent to provide informed consent to voluntarily participate in the study. Exclusion Criteria: People who meet the criteria for diabetes, (i.e., repeat fasting blood glucose (FBG) >7 mmol/l or, 2 hr. post-load glucose >11.1 mmol. as determined by a 2 hr. glucose tolerance test (GTT)). People with evidence of clinically significant liver disease, renal or gastrointestinal impairments, as suggested by clinical history and liver and kidney functions tests. Any impairment deemed clinically significant would be a relative contra-indication for the use of metformin. Women in the child bearing age, who are not willing to use contraceptive measures. People with other comorbid disorders such as clinically significant heart or lung disease that may prevent participation in various physical activities or disorders of glucose metabolism (e.g., Cushing's Syndrome, Acromegaly, and chronic pancreatitis). People with treatments that would interfere with participation or completion of the protocol (e.g., in shared care and planning to be discharged shortly from the clinic), or having a confounding effect on the measurement of the primary outcomes of the study (prescription weight loss drugs, lipid lowering agents?) People with weight loss >10% in past 6 months
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lakshmi P Voruganti, MD
Phone
905-522-1155
Ext
6355
Email
vorugl@mcmaster.ca
First Name & Middle Initial & Last Name or Official Title & Degree
Susan Strong, MSc
Phone
905-522-1155
Email
strongs@mcmaster.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lakshmi P Voruganti, MD
Organizational Affiliation
McMaster University
Official's Role
Principal Investigator
Facility Information:
Facility Name
McMaster University
City
Hamilton
State/Province
Ontario
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lakshmi P Voruganti, MD
Phone
905-522-1155
Ext
6355
Email
vorugl@mcmaster.ca
First Name & Middle Initial & Last Name & Degree
Susan Strong, MSc
Phone
905 522 1155
Email
strongs@mcmaster.ca
First Name & Middle Initial & Last Name & Degree
Lakshmi P Voruganti, MD

12. IPD Sharing Statement

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Diabetes Prevention Program in Schizophrenia [DPPS]

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