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

Launched by STENO DIABETES CENTER COPENHAGEN · Feb 28, 2025

Keywords

ClinConnect Summary

This clinical trial is studying the connection between two types of nerve damage commonly seen in people with type 2 diabetes—peripheral neuropathy and cardiovascular autonomic neuropathy—and cognitive decline, which refers to difficulties with thinking and memory. Researchers want to find out if having these types of nerve damage increases the risk of cognitive impairment. They are looking for participants aged 65 and older, both with and without type 2 diabetes, who meet specific health criteria. For those with diabetes, it is important that they have had the condition for over five years and are stable on their diabetes treatment.

Participants in the study can expect to undergo a series of assessments to evaluate their nerve function and cognitive abilities. This includes tests to measure how well they think and remember, as well as blood tests and possibly brain scans (MRI) to look at brain structure and function. The study is currently recruiting, and it's important for participants to understand that they will need to provide written consent and speak Danish for the tests. Overall, this research aims to better understand how diabetes-related nerve damage might affect brain health in older adults.

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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.