The Sunnybrook Type 2 Diabetes Study
Recruiting · NCT04455867 · Observational (researchers observe without assigning treatment) · Lead sponsor: Sunnybrook Health Sciences Centre
View the official record on ClinicalTrials.gov →Interventions studied
Diabetes Exercise and Healthy Lifestyle ProgramOutpatient care
What this trial is about
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.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not specified
Study type
Observational (researchers observe without assigning treatment)
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 is running
1 location listed.
- Sunnybrook Research Institute - Toronto, Ontario, Canada