Diabetes Prevention Program in Schizophrenia [DPPS]

NCT00182494 | Unknown Phase 4

• 1 other identifier: 04-2417
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes Mellitus; Schizophrenia

Keywords

Schizophrenia, Diabetes, Weight gain, Antipsychotic drugs

Outcome Measures

Primary Outcomes (3)

• 1. Adherence/ability to run as designed /recruitment

• 2. Impact on modifiable diabetes risk factors

• 3. Impact on incidence of diabetes

Secondary Outcomes (3)

• 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

Interventions

Modified diabetes prevention protocol & Metformin BEHAVIORAL

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Hamilton Health Sciences Corporation: lead
• The Lawson Foundation: collaborator
• Ontario Mental Health Foundation: collaborator

Study Sites (1)

McMaster University

Hamilton, Ontario, Canada

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus; Schizophrenia; Weight Gain

Interventions

Metformin

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders; Body Weight Changes; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Biguanides; Guanidines; Amidines; Organic Chemicals

Study Officials

• Lakshmi P Voruganti, MD

  McMaster University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lakshmi P Voruganti, MD

CONTACT

905-522-1155; vorugl@mcmaster.ca

Susan Strong, MSc

CONTACT

905-522-1155; strongs@mcmaster.ca

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 14, 2005
• First Posted: September 16, 2005
• Study Start: February 1, 2005
• Study Completion: January 1, 2009
• Last Updated: September 16, 2005

Record last verified: 2005-07

Locations

CA (1)