Observational study on mood and cognition in people with Type 2 Diabetes and prediabetes
The Sunnybrook Type 2 Diabetes Study
This study looks at how mood and thinking skills are affected in people with Type 2 diabetes or prediabetes to see what factors might play a role over 18 months.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 500 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Sunnybrook Health Sciences Centre Academic / other |
| Locations | 1 site (Toronto, Ontario) |
| Trial ID | NCT04455867 on ClinicalTrials.gov |
What this trial studies
The Sunnybrook Type 2 Diabetes Study is a prospective observational study that investigates the causes and effects of mood and cognitive complications in individuals with prediabetes or Type 2 Diabetes Mellitus. Participants are recruited from Sunnybrook Health Sciences Centre and the University Health Network Toronto Rehabilitation Institute, where they receive care and participate in a hybrid exercise program. The study includes assessments of cognitive performance, mood symptoms, and various lifestyle factors over a period of 18 months. Data collected will also be linked to public health records to evaluate long-term health outcomes.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with prediabetes or Type 2 Diabetes Mellitus who can communicate in English.
Not a fit: Patients with current cancer diagnoses, severe mental health disorders, or neurological conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance understanding of the mental health challenges faced by patients with Type 2 Diabetes and prediabetes, leading to improved management strategies.
How similar studies have performed: Other studies have shown success in exploring the relationship between diabetes and cognitive/mood complications, making this approach both relevant and supported by prior research.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Toronto, Ontario
- Sunnybrook Research Institute — Toronto, Ontario, Canada (Recruiting)
Study contacts
- Principal investigator: Walter Swardfager, PhD — Sunnybrook Research Institute
- Study coordinator: Walter Swardfager, PhD
- Email: w.swardfager@utoronto.ca
- Phone: 416-480-6100
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.