A Lifestyle and Combination Medication Therapy Diabetes Prevention Study

• Status: Completed
• Trial end date: 2010-01-01
• Target enrollment: 0
• Participant gender: All

Summary

It is now well established that the 21st century will be characterized by a global epidemic of Type 2 diabetes. The principal aim of the CANOE study is to determine whether individuals with the pre-diabetes condition impaired glucose tolerance can be prevented from progressing to diabetes with a healthy living lifestyle intervention and an insulin sensitizing medication. Individuals who have impaired glucose tolerance (IGT) determined during an oral glucose tolerance test will be eligible to participate in this study. All participants will receive a lifestyle dietary and exercise intervention program. Half of the participants will be randomly assigned to an insulin sensitizing medication (rosiglitazone/metformin) which is commonly used to treat Type 2 diabetes. The primary outcome for this study is the development of diabetes. The study is expected to last a total of five years.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Samuel Lunenfeld Research Institute, Mount Sinai Hospital
• Collaborator: University of Western Ontario, Canada
• Treatments: Metformin; Rosiglitazone

Criteria

Inclusion Criteria:

• Residents of Ontario

• Age 18-75

• IGT on OGTT

Exclusion Criteria:

• Current use of Metformin or Rosiglitazone

• Prior use of medication to treat diabetes except gestational diabetes

• Use of drugs known to exacerbate glucose tolerance

• History of diabetes except gestational diabetes

• Liver function studies greater the 2.5x normal

• Creatinine clearance less than 60 ml/min