The Association Between Cognitive Function and Neuropathy in Individuals With Type 2 Diabetes

Summary

The goal of this observational study is to evaluate whether individuals with different types of diabetic neuropathy (peripheral and cardiovascular autonomic neuropathy) are at an increased risk of cognitive impairment and to investigate the potential reasons for this association. The primary research question is: Is diabetic peripheral and cariovascular autonomic neuropathy in type 2 diabetes associated with cognitive decline? To address this question, the study will include individuals with and without type 2 diabetes. All participants will undergo comprehensive neuropathy assessments, neuropsychological evaluations and blood biomarker analysis. In addition, some individuals will undergo structural and functional brain MRI.

Eligibility

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.

Conditions5

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