The Sunnybrook Type 2 Diabetes Study
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- STATUS
- Recruiting
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- End date
- Dec 5, 2026
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- participants needed
- 500
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- sponsor
- Sunnybrook Health Sciences Centre
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.
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 Institute Cardiac Rehabilitation Program. Participants recruited from Sunnybrook are receiving care from services there (e.g. Family Medicine, Endocrinology, and the Sunnybrook Diabetes Education Centre). Participants recruited from the Toronto Rehab are undertaking a 6-month stepped hybrid (home and clinic based) aerobic plus resistance exercise intervention as part of a program at that site (e.g. the Diabetes, Exercise, and Healthy Lifestyle Program).
Study assessments are conducted at baseline, 3 months, 6 months and 18 months. Main outcomes include cognitive performance, assessed using a detailed neurocognitive battery, and mood symptoms assessed via research criteria for a depressive episode and self-report instruments. Other lifestyle factors are also examined, including physical activity, sleep quality, diet, and subjective stress. Diabetes complications and characteristics are monitored, as are all concomitant medications and supplements. With permission, participant data are linked prospectively to public health records to ascertain long-term outcomes and health services utilization.
The cohort is characterized using biological, neuroimaging and biometric measures. Fasting morning blood and urine samples are taken at each assessment. Serum, plasma, whole blood, and white blood cells are bio-banked for biochemical, genetic and other analyses. The MRI study includes a 1.5 hr MRI scan at 3.0 T. Sequences performed include structural imaging (T1, T2, DTI and FLAIR) and resting state functional MRI. Two optional sub-studies are offered: a cerebrovascular reactivity MRI protocol, and a sleep quality and apnea protocol (baseline, 6 month and 18 month visits). The sleep study uses an overnight wearable sleep monitor.
Details
| Condition | NIDDM, diabetes mellitus, type 2, Diabetes Mellitus, diabetes (pediatric), Prediabetes, diabetes (pediatric), diabetes mellitus, type 2 |
|---|---|
| Age | 18-100 years |
| Treatment | Diabetes Exercise and Healthy Lifestyle Program, Outpatient care |
| Clinical Study Identifier | NCT04455867 |
| Sponsor | Sunnybrook Health Sciences Centre |
| Last Modified on | 19 February 2024 |
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.
Learn moreIf you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.
Learn moreComplete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.
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