Diabetes Prevention Program in Schizophrenia [DPPS]

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2005 by McMaster University.
Recruitment status was  Recruiting
Sponsor:
Collaborators:
The Lawson Foundation
Ontario Mental Health Foundation
Information provided by:
McMaster University
ClinicalTrials.gov Identifier:
NCT00182494
First received: September 14, 2005
Last updated: NA
Last verified: July 2005
History: No changes posted
  Purpose

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.


Condition Intervention Phase
Diabetes Mellitus
Schizophrenia
Behavioral: Modified diabetes prevention protocol & Metformin
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Prevention
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.

Resource links provided by NLM:


Further study details as provided by McMaster University:

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

Estimated Enrollment: 200
Study Start Date: February 2005
Estimated Study Completion Date: January 2009
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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. 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.
  2. 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.
  3. People who have gained > 10% body weight since??? Or body mass index > 24 kg/m², except Asian decent at 22 kg/m² or greater??
  4. Competent to provide informed consent to voluntarily participate in the study.

Exclusion Criteria:

  1. 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)).
  2. 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.
  3. Women in the child bearing age, who are not willing to use contraceptive measures.
  4. 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).
  5. 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?)
  6. People with weight loss >10% in past 6 months
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00182494

Contacts
Contact: Lakshmi P Voruganti, MD 905-522-1155 ext 6355 vorugl@mcmaster.ca
Contact: Susan Strong, MSc 905-522-1155 strongs@mcmaster.ca

Locations
Canada, Ontario
McMaster University Recruiting
Hamilton, Ontario, Canada
Contact: Lakshmi P Voruganti, MD    905-522-1155 ext 6355    vorugl@mcmaster.ca   
Contact: Susan Strong, MSc    905 522 1155    strongs@mcmaster.ca   
Principal Investigator: Lakshmi P Voruganti, MD         
Sponsors and Collaborators
Hamilton Health Sciences Corporation
The Lawson Foundation
Ontario Mental Health Foundation
Investigators
Principal Investigator: Lakshmi P Voruganti, MD McMaster University
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00182494     History of Changes
Other Study ID Numbers: 04-2417
Study First Received: September 14, 2005
Last Updated: September 14, 2005
Health Authority: United States: Food and Drug Administration
Canada: Therapeutic Products Directorate, Health Canada

Keywords provided by McMaster University:
Schizophrenia, Diabetes, Weight gain, Antipsychotic drugs

Additional relevant MeSH terms:
Diabetes Mellitus
Schizophrenia
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Schizophrenia and Disorders with Psychotic Features
Mental Disorders
Metformin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 19, 2014