🇮🇪Ireland
16°C Partly Cloudy · Dublin
Live Updates
--:--:-- IST
Contributor sign in
Latest
Clinical Trials in Canada / NCT04455867
Recruiting Observational

The Sunnybrook Type 2 Diabetes Study

NCT04455867 · tracked via the Priya Life Science Canada tracker
Phase
Observational
Started
2017-12-21
Last updated
2023-04-12

Condition(s) studied

Type 2 DiabetesPreDiabetes

Investigational drug(s) / intervention(s)

Diabetes Exercise and Healthy Lifestyle ProgramOutpatient care

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

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Sunnybrook Research Institute Toronto Ontario Recruiting

More Sunnybrook Health Sciences Centre trials in Canada

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04455867 on ClinicalTrials.gov ↗ ← All trials in Canada