Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
500 participants
OBSERVATIONAL
2017-12-21
2026-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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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).
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.
Outpatient care
Participants receive usual care from outpatient services, which may include Endocrinology, Family Medicine, or Diabetes Education
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
* Be able to communicate in English
* Be 18 years of age or older
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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University Health Network, Toronto
OTHER
University of Toronto
OTHER
Sunnybrook Health Sciences Centre
OTHER
Responsible Party
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Walter Swardfager
Principal Investigator
Principal Investigators
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Walter Swardfager, PhD
Role: PRINCIPAL_INVESTIGATOR
Sunnybrook Research Institute
Locations
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Sunnybrook Research Institute
Toronto, Ontario, Canada
Countries
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Central Contacts
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Facility Contacts
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References
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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.
Other Identifiers
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0939
Identifier Type: REGISTRY
Identifier Source: secondary_id
422-2015
Identifier Type: -
Identifier Source: org_study_id
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