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 @ 1:42 AM
Ignite Modification Date:
2025-12-25 @ 1:42 AM
NCT ID:
NCT06857994
Eligibility Criteria:
Since the study includes both individuals with and without diabetes, there are two sets of inclusion criteria. Exclusion criteria apply to both indivdiuals with and without diabetes.
Inclusion Criteria:
For individuals with type 2 diabetes:
* Age \>= 65 years
* Type 2 Diabetes diagnosis (defined according to the criteria from World Health Organization) for more than 5 years
* BMI \<= 35
* Stable diabetes treatment for at least 8 weeks (adjustments of already prescribed insulin doses are accepted)
* Plasma hemoglobin ≥ 8.00 mmol/L (male) or ≥ 6.4 mmol/L (female)
* Speaks and understands Danish (required for the cognitive tests)
* Informed and written consent
For individuals without type 2 diabetes:
* Age ≥ 65 years
* Not diagnosed with T2D diagnosis (defined according to criteria from World Health Organization (WHO))
* Speaks and understands Danish (required for the cognitive tests)
* Informed and written consent
Exclusion Criteria (all individuals):
* Any medical condition which, based on investigators assessment, challenges or hinders participation in cognitive screening, impedes compliance with the study protocol or evaluation of results, including but not limited to psychiatric disorders, neurological disorders, chronic pain disorders etc.
* Significant history of alcoholism or drug/chemical substance abuse as per the investigator's judgement.
* Individuals in active laser treatment for retinopathy, atrial fibrillation, atrial flutter, or pacemakers since these cannot take part in CAN measurements.
* Individuals unable to take part in the MRI because of e.g., metallic objects in the body or severe claustrophobia.
* Individuals who do not wish to be informed about accidental findings by MR.
* Diagnosis of dementia (ICD F00-F03) or participants who have previously been referred to a dementia clinic.
* Severe hypoglycemic events during the past 6 months requiring medical assistance.
* Severe renal insufficiency as eGFR ≤ 30 ml/min/1.73 m2
* Inadequately treated blood pressure at screening defined as repeated resting blood pressure outside the range of 90-150 mmHg for systolic and 50-100 for diastolic.
* Active or recent (≤ 12 months) malignant disease as judged by the investigator.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
65 Years
Study:
NCT06857994
Study Brief:
Protocol Section:
NCT06857994