Clinical trial NCT04455867: The Sunnybrook Type 2 Diabetes Study
Official title: The Sunnybrook Type 2 Diabetes Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Type 2 Diabetes
PreDiabetes
Keywords: Mood
Cognition
Brain Imaging
Type 2 Diabetes
Sleep
Exercise
Lead sponsor: Sunnybrook Health Sciences Centre
Sponsor class: OTHER
Collaborators: name: University Health Network, Toronto
name: University of Toronto
First posted: 2020-07-02
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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.

Eligibility criteria: 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 outcomes:
measure: Depressive episode
timeFrame: 6 Months
measure: Neuropsychological function
timeFrame: 6 Months
Secondary outcomes:
measure: Depressive symptoms
timeFrame: Baseline, 3 Month, 6 Month, 18 Month
measure: Cognitive Status
timeFrame: Baseline, 3 Month, 6 Month, 18 Month
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Sunnybrook Research Institute
state: Ontario
Study officials:
affiliation: Sunnybrook Research Institute
name: Walter Swardfager, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.