Recruiting

Observational Study

Sponsor:

Sunnybrook Health Sciences Centre

Code:

NCT04455867

Conditions

Type 2 Diabetes

PreDiabetes

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Diabetes Exercise and Healthy Lifestyle Program

Outpatient care

Study Details

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.

Conditions

Type 2 Diabetes

PreDiabetes

Study ID

NCT04455867

Start date

Dec 21, 2017

Status verified date

Apr, 2023

Completion date

Dec, 2026

Anticipated

Primary completion date

Dec, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

500 participants

Anticipated

Interventions and Outcome Measures

Arms

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

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.

Outpatient care

Participants receive usual care from outpatient services, which may include Endocrinology, Family Medicine, or Diabetes Education

Primary outcome measure

  • Depressive episode [ Time Frame: 6 Months ]
  • Neuropsychological function [ Time Frame: 6 Months ]

Central Contacts and Locations

Central contacts

Walter Swardfager, PhD

416-480-6100w.swardfager@utoronto.ca

Chelsi Major-Orfao, MEd

416-480-6100chelsi.major-orfao@sri.utoronto.ca

Locations

Sunnybrook Research Institute

Recruiting

Toronto, Ontario, Canada, M4N 3M5

Contacts

Walter Swardfager, PhD

416-480-6100w.swardfager@utoronto.ca

Chelsi Major-Orfao, MEd

416-480-6100chelsi.major-orfao@sri.utoronto.ca

Principal Investigator:

Walter Swardfager, PhD

More Information

Sponsor

Sunnybrook Health Sciences Centre

Last update posted

Apr 12, 2023

Last verified

Apr, 2023

Keywords

  • Mood
  • Cognition
  • Brain Imaging
  • Type 2 Diabetes
  • Sleep
  • Exercise

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Sunnybrook Health Sciences Centre on 2023-04-12.