Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 12:27 AM
Ignite Modification Date:
2025-12-25 @ 12:27 AM
NCT ID:
NCT04455867
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04455867
Study Brief:
Protocol Section:
NCT04455867