Status:
RECRUITING
The Sunnybrook Type 2 Diabetes Study
Lead Sponsor:
Sunnybrook Health Sciences Centre
Collaborating Sponsors:
University Health Network, Toronto
University of Toronto
Conditions:
Type 2 Diabetes
PreDiabetes
Eligibility:
All Genders
18+ years
Brief Summary
The Sunnybrook Type 2 Diabetes Study (S2DS) is a prospective observational study of people with prediabetes or Type 2 Diabetes Mellitus (T2DM), that aims to understand the aetiologies, manifestations,...
Detailed Description
The S2DS is a prospective observational study of people with prediabetes or T2DM recruited from Sunnybrook Health Sciences Centre and the neighbouring University Health Network Toronto Rehabilitation ...
Eligibility Criteria
Inclusion
- Have at least one of the following: high HbA1c, impaired fasting glucose (IFG), impaired glucose tolerance (IGT), but not yet diagnosed with Type 2 diabetes or have a diagnosis of Type 2 diabetes.
- Be able to communicate in English
- Be 18 years of age or older
Exclusion
- Pregnancy
- Inability to give informed consent
- Current cancer diagnosis
- Have a prior diagnosis of bipolar disorder or schizophrenia.
- Have a prior diagnosis of a neurological and/or neurodegenerative disorder.
- Have a current substance use disorder or a previous substance use disorder diagnosed within the last 5 years (excluding nicotine)
- Poor score on the Mini Mental State Examination (MMSE)
- Exclusion criteria (Brain Imaging Sub-Study):
- Contraindications to SHSC's MRI safety protocol.
- Participants that do not meet the inclusion/exclusion criteria of the main study.
- Exclusion criteria for (Brain Imaging Sub-Study - CVR procedure):
- Use of medical equipment that would interfere with the placement of the CVR mask.
- Significant pulmonary disease (e.g. asthma, pulmonary fibrosis, emphysema, chronic obstructive pulmonary disease, pulmonary vascular disease, pleural disorders, pneumonia)
- Participants that do not meet the criteria for the MRI sub-study.
- Exclusion criteria (Sleep Quality and Apnea Sub-Study):
- Participants that have a medical device that would interfere with placement of portable sleep monitor equipment i.e. Participant requires O2 therapy and uses nasal prongs
- Participants that have a condition that may compromise accuracy of the HSAT results i.e. moderate-severe pulmonary disease or congestive heart failure
- Participants that do not meet the inclusion/exclusion criteria of the main study
Key Trial Info
Start Date :
December 21 2017
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 1 2026
Estimated Enrollment :
500 Patients enrolled
Trial Details
Trial ID
NCT04455867
Start Date
December 21 2017
End Date
December 1 2026
Last Update
April 12 2023
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Sunnybrook Research Institute
Toronto, Ontario, Canada, M4N 3M5