Observational study on mood and cognition in people with Type 2 Diabetes and prediabetes

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.