The Sunnybrook Type 2 Diabetes Study (S2DS)

April 10, 2023 updated by: Walter Swardfager, Sunnybrook Health Sciences Centre
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 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.

Study Type

Observational

Enrollment (Anticipated)

500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M4N 3M5
        • Recruiting
        • Sunnybrook Research Institute
        • Contact:
        • Contact:
        • Principal Investigator:
          • Walter Swardfager, PhD
        • Principal Investigator:
          • Paul I Oh, MD
        • Sub-Investigator:
          • Krista L Lanctot, PhD
        • Sub-Investigator:
          • Baiju R Shah, MD, PhD
        • Sub-Investigator:
          • Jane Mitchell, PhD
        • Sub-Investigator:
          • Nathan Herrmann, MD
        • Sub-Investigator:
          • Sandra E Black, MD
        • Sub-Investigator:
          • Pearl Yang, MD, PhD
        • Sub-Investigator:
          • Bradley J MacIntosh, PhD
        • Sub-Investigator:
          • Alexander Kiss, PhD
        • Sub-Investigator:
          • Mark I Boulos, MD
        • Sub-Investigator:
          • Jaan Reitav, PhD
        • Sub-Investigator:
          • Jeremy Gilbert, MD
        • Sub-Investigator:
          • Ilana J Halperin, MD
        • Sub-Investigator:
          • Angela Assal, MD
        • Sub-Investigator:
          • Andrew Lim, MD
        • Sub-Investigator:
          • Jennifer S Rabin, PhD
        • Sub-Investigator:
          • Maged Goubran, PhD
        • Sub-Investigator:
          • Ana C Andreazza, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

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.

Description

Inclusion Criteria:

  • 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 Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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).
Behavioral: Diabetes Exercise and Healthy Lifestyle Program
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.
Sunnybrook Health Sciences Centre
Participants with prediabetes or T2DM receiving care from an outpatient service at Sunnybrook Health Sciences Centre.
Other: Outpatient care
Participants receive usual care from outpatient services, which may include Endocrinology, Family Medicine, or Diabetes Education

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Depressive episode
Time Frame: 6 Months
Depressive episodes are identified using a Structured Clinical Interview for the DSM-5 criteria (SCID-5RV).
6 Months
Neuropsychological function
Time Frame: 6 Months
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Depressive symptoms
Time Frame: Baseline, 3 Month, 6 Month, 18 Month
Depressive symptoms are monitored using the Beck Depression Inventory-II (BDI-II).
Baseline, 3 Month, 6 Month, 18 Month
Cognitive Status
Time Frame: Baseline, 3 Month, 6 Month, 18 Month
Cognitive status is monitored using the Montreal Cognitive Assessment (MoCA).
Baseline, 3 Month, 6 Month, 18 Month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sunnybrook Health Sciences Centre

Collaborators

University Health Network, Toronto
University of Toronto

Investigators

  • Principal Investigator: Walter Swardfager, PhD, Sunnybrook Research Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 21, 2017

Primary Completion (Anticipated)

December 1, 2025

Study Completion (Anticipated)

December 1, 2026

Study Registration Dates

First Submitted

June 22, 2020

First Submitted That Met QC Criteria

June 30, 2020

First Posted (Actual)

July 2, 2020

Study Record Updates

Last Update Posted (Actual)

April 12, 2023

Last Update Submitted That Met QC Criteria

April 10, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 422-2015
  • 0939 (Registry Identifier: Clinical Trials Ontario)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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