Type 2 DiabetesS2DSNCT04455867
The Sunnybrook Type 2 Diabetes Study
An observational study of Type 2 Diabetes and PreDiabetes, run by Sunnybrook Health Sciences Centre at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Type 2 Diabetes, PreDiabetes
- What is being tested?
- Diabetes Exercise and Healthy Lifestyle Program and Outpatient care
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 500 participants
- Where
- 1 siteCanada
- Study dates
- 21 Dec 2017to Dec 2026
- How long will I take part?
- 18 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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)
Show all 16Show fewer
- Poor score on the Mini Mental State Examination (MMSE)
- 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.
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
Sunnybrook Research Institute
Toronto, Ontario, M4N 3M5
Walter Swardfager, PhD, 416-480-6100, w.swardfager@utoronto.ca
Chelsi Major-Orfao, MEd, 416-480-6100 ext. 85404, chelsi.major-orfao@sri.utoronto.ca
About this study
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.
Read the 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.
- Conditions
- Type 2 Diabetes, PreDiabetes
- Being tested
- Diabetes Exercise and Healthy Lifestyle Program, Outpatient care
- Keywords
- Mood, Cognition, Brain Imaging, Type 2 Diabetes, Sleep, Exercise
- Medical subject headings
- Diabetes Mellitus, Type 2, Prediabetic State, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diabetes Exercise and Healthy Lifestyle ProgramBehavioural
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 careOther
Participants receive usual care from outpatient services, which may include Endocrinology, Family Medicine, or Diabetes Education
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Behavioral: 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. Receives: Other: Outpatient care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Depressive episode
Depressive episodes are identified using a Structured Clinical Interview for the DSM-5 criteria (SCID-5RV).
Measured: 6 Months
Neuropsychological function
A Z-score computed from a sensitive neuropsychological battery is administered based on the Canadian Stroke Network \& National Institutes of Neurological Disorders recommendations.
Measured: 6 Months
Secondary outcomes (2)
Depressive symptoms
Depressive symptoms are monitored using the Beck Depression Inventory-II (BDI-II).
Measured: Baseline, 3 Month, 6 Month, 18 Month
Cognitive Status
Cognitive status is monitored using the Montreal Cognitive Assessment (MoCA).
Measured: Baseline, 3 Month, 6 Month, 18 Month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2020
- Study start21 Dec 2017
- Primary completionDec 2025 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
- Target duration
- 18 Months
Sponsor and investigators
- Lead sponsor
- Sunnybrook Health Sciences Centre
- Sponsor type
- University, hospital or other
- Collaborators
- University Health Network, Toronto, University of Toronto
- Responsible party
- Principal investigator, Walter Swardfager, Sunnybrook Health Sciences Centre
- Investigators
- Walter Swardfager, PhD, Principal investigator, Sunnybrook Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04455867
- Sponsor's protocol ID
- 422-2015
- Other IDs
- 0939
- Acronym
- S2DS
- Status last verified
- Apr 2023
- First submitted
- 22 Jun 2020
- Last updated
- 12 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 33503568
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Sunnybrook Type 2 Diabetes Study
- ClinicalTrials.gov ID
- NCT04455867
- Acronym / sponsor ID
- S2DS / 422-2015
- Conditions
- Type 2 Diabetes, PreDiabetes
- Keywords
- Mood, Cognition, Brain Imaging, Type 2 Diabetes, Sleep, Exercise
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Sunnybrook Health Sciences CentreUniversity, hospital or other
- Collaborators
- University Health Network, Toronto, University of Toronto
- Study start
- 21 Dec 2017 (actual)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 2 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 18 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| UHN Toronto Rehab | – | Behavioral: Diabetes Exercise and Healthy Lifestyle ProgramParticipants 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 | – | Other: Outpatient careParticipants with prediabetes or T2DM receiving care from an outpatient service at Sunnybrook Health Sciences Centre. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (16 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Diabetes Exercise and Healthy Lifestyle ProgramThe 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. | Behavioural | UHN Toronto Rehab |
| Outpatient careParticipants receive usual care from outpatient services, which may include Endocrinology, Family Medicine, or Diabetes Education | Other | Sunnybrook Health Sciences Centre |
Primary outcome
Depressive episode
Time frame: 6 Months
Depressive episodes are identified using a Structured Clinical Interview for the DSM-5 criteria (SCID-5RV).
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.
2 secondary outcomes
Depressive symptoms
Time frame: Baseline, 3 Month, 6 Month, 18 Month
Cognitive Status
Time frame: Baseline, 3 Month, 6 Month, 18 Month
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2023.
- Derived from this study: PubMed 33503568Anita 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Walter Swardfager, PhD principal investigator
Sunnybrook Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Type 2 Diabetes and PreDiabetes, run by Sunnybrook Health Sciences Centre at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 12 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Walter Swardfager, PhD (416-480-6100 ext. 85409, w.swardfager@utoronto.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Depressive episode (time frame: 6 Months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04455867, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Apr 2023.