The Sunnybrook Type 2 Diabetes Study
S2DS
2 other identifiers
observational
500
1 country
1
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, and clinical consequences of mood and cognitive complications. The study recruits from the services at Sunnybrook Health Sciences Centre and from the neighbouring University Health Network Toronto Rehabilitation Institute Cardiac Rehabilitation Program.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Dec 2017
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 21, 2017
CompletedFirst Submitted
Initial submission to the registry
June 22, 2020
CompletedFirst Posted
Study publicly available on registry
July 2, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2026
ExpectedApril 12, 2023
April 1, 2023
8 years
June 22, 2020
April 10, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Depressive episode
Depressive episodes are identified using a Structured Clinical Interview for the DSM-5 criteria (SCID-5RV).
6 Months
Neuropsychological function
A Z-score computed from a sensitive neuropsychological battery is administered based on the Canadian Stroke Network \& National Institutes of Neurological Disorders recommendations.
6 Months
Secondary Outcomes (2)
Depressive symptoms
Baseline, 3 Month, 6 Month, 18 Month
Cognitive Status
Baseline, 3 Month, 6 Month, 18 Month
Study Arms (2)
UHN Toronto Rehab
Participants with prediabetes of T2DM undertaking a 6-month stepped hybrid (home and clinic based) aerobic plus resistance exercise intervention as per the site's standard protocol (Diabetes Exercise and Healthy Lifestyle Program).
Sunnybrook Health Sciences Centre
Participants with prediabetes or T2DM receiving care from an outpatient service at Sunnybrook Health Sciences Centre.
Interventions
The program combines exercise, education and healthy lifestyle behaviour changes. Participants will begin the program with a cardiopulmonary exercise assessment. Then the team will create a personalized program of exercise based on functional abilities and personal goals. Participants will attend 1 supervised exercise class a week, which includes a warm-up and stretching routine, aerobic exercise (walking, stationary cycling or elliptical machine), resistance training and an educational session. This program also offers peer-to-peer support and encourages participants to carry out their own exercise program at home 4 more times per week and to keep a weekly exercise diary to help them with their progress.
Participants receive usual care from outpatient services, which may include Endocrinology, Family Medicine, or Diabetes Education
Eligibility Criteria
The study population consists of individuals with prediabetes or T2DM who are receiving care from an outpatient service at Sunnybrook Health Sciences Centre, or as part of the Diabetes and Healthy Lifestyle Program at the University Health Network Toronto Rehabilitation Institute Cardiac Rehabilitation Program.
You may qualify if:
- 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
You may not qualify if:
- 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)
- Contraindications to SHSC's MRI safety protocol.
- 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.
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Sunnybrook Health Sciences Centrelead
- University Health Network, Torontocollaborator
- University of Torontocollaborator
Study Sites (1)
Sunnybrook Research Institute
Toronto, Ontario, M4N 3M5, Canada
Related Publications (1)
Anita NZ, Forkan N, Kamal R, Nguyen MM, Yu D, Major-Orfao C, Wong SK, Lanctot KL, Herrmann N, Oh PI, Shah BR, Gilbert J, Assal A, Halperin IJ, Pedersen TL, Taha AY, Swardfager W. Serum soluble epoxide hydrolase related oxylipins and major depression in patients with type 2 diabetes. Psychoneuroendocrinology. 2021 Apr;126:105149. doi: 10.1016/j.psyneuen.2021.105149. Epub 2021 Jan 19.
PMID: 33503568DERIVED
Biospecimen
Serum Plasma White blood cells Urine
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Walter Swardfager, PhD
Sunnybrook Research Institute
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 18 Months
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
June 22, 2020
First Posted
July 2, 2020
Study Start
December 21, 2017
Primary Completion
December 1, 2025
Study Completion (Estimated)
December 1, 2026
Last Updated
April 12, 2023
Record last verified: 2023-04
Data Sharing
- IPD Sharing
- Will not share