NCT04455867Recruiting
The Sunnybrook Type 2 Diabetes Study
Source: ClinicalTrials.gov · Last updated 12 Apr 2023 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 500 (estimated)
- First submitted
- 22 Jun 2020
- Start date
- 21 Dec 2017
- Primary completion date
- Dec 2025
- Lead sponsor
- Sunnybrook Health Sciences Centre
- Diseases
- Type 2 diabetes
- NCT number
- NCT04455867
What you commit to
- Study type: Observational
- Planned participants: 500
- From 21 Dec 2017 to the primary completion date, Dec 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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)
- 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
Other illness
- Current cancer diagnosis
- Significant pulmonary disease (e.g. asthma, pulmonary fibrosis, emphysema, chronic obstructive pulmonary disease, pulmonary vascular disease, pleural disorders, pneumonia)
- Participants that have a condition that may compromise accuracy of the HSAT results i.e. moderate-severe pulmonary disease or congestive heart failure
Other
- Pregnancy
- Inability to give informed consent
- 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.
- Use of medical equipment that would interfere with the placement of the CVR mask.
- Participants that do not meet the criteria for the MRI sub-study.
- Participants that do not meet the inclusion/exclusion criteria of the main study
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Sunnybrook Research Institute Coordinator of this site? Confirm its status | Toronto | Canada | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.