Examining the link between cognitive function and neuropathy in people with type 2 diabetes
The Association Between Cognitive Function and Diabetic Neuropathy in Individuals With Type 2 Diabetes
This study is trying to see if nerve damage from diabetes affects thinking skills in people with type 2 diabetes.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 96 (estimated) |
| Ages | 65 Years and up |
| Sex | All |
| Sponsor | Steno Diabetes Center Copenhagen Academic / other |
| Locations | 1 site (Herlev) |
| Trial ID | NCT06857994 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate the relationship between different types of diabetic neuropathy, specifically peripheral and cardiovascular autonomic neuropathy, and cognitive impairment in individuals with type 2 diabetes. Participants, both with and without diabetes, will undergo comprehensive assessments including neuropathy evaluations, neuropsychological testing, and blood biomarker analysis. A subset of participants will also receive structural and functional brain MRI scans to investigate potential brain changes associated with neuropathy. The study seeks to clarify whether diabetic neuropathy contributes to cognitive decline and the underlying mechanisms involved.
Who should consider this trial
Good fit: Ideal candidates include individuals aged 65 and older, both with and without a diagnosis of type 2 diabetes.
Not a fit: Patients under 65 years of age or those with conditions that may confound cognitive assessments may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance understanding of the cognitive risks associated with diabetic neuropathy, potentially leading to improved management strategies for patients with type 2 diabetes.
How similar studies have performed: While the association between diabetes and cognitive decline has been explored, this specific focus on neuropathy's role is relatively novel and not extensively tested.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Herlev
- Steno Diabetes Center Copenhagen — Herlev, Denmark (Recruiting)
Study contacts
- Study coordinator: Astrid Wiggers, MD, PhD student
- Email: astrid.wiggers@regionh.dk
- Phone: +45 23 29 92 82
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.