Recruiting

Diabetes Prevention Program

Sponsor:

Hamilton Health Sciences Corporation

Code:

NCT00182494

Conditions

Diabetes Mellitus

Schizophrenia

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Interventions

Modified diabetes prevention protocol & Metformin

Study Details

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

Study ID

NCT00182494

Start date

Feb, 2005

Status verified date

Jul, 2005

Completion date

Jan, 2009

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

200 participants

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Interventions

Modified diabetes prevention protocol & Metformin

Primary outcome measure

  • 1. Adherence/ability to run as designed /recruitment [ Time Frame: undefined ]
  • 2. Impact on modifiable diabetes risk factors [ Time Frame: undefined ]
  • 3. Impact on incidence of diabetes [ Time Frame: undefined ]

Central Contacts and Locations

Central contacts

Locations

McMaster University

Recruiting

Hamilton, Ontario, Canada

Contacts

Principal Investigator:

Lakshmi P Voruganti, MD

More Information

Sponsor

Hamilton Health Sciences Corporation

Last update posted

Sep 16, 2005

Last verified

Jul, 2005

Keywords

  • Schizophrenia, Diabetes, Weight gain, Antipsychotic drugs

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Hamilton Health Sciences Corporation on 2005-09-16.