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

NCT06857994 | Completed

• 1 other identifier: H-24014649
• Study Type: observational
• Target: 101
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Cardiovascular Autonomic Neuropathy; Diabetes Type 2; Peripheral Diabetic Neuropathy; Cognitive Impairment

Outcome Measures

Primary Outcomes (1)

• Cognitive composite score (global score)

  The global score is based on the scores the neuropsychological test battery. The tests are grouped based on cognitive domains and the global cognitive score is assessed by the mean of individual component z-scores. The neuropsychological test battery will include the following: * Rey Auditory Verbal Learning Test (RAVLT) * Trail Making Test (TMT) part A and B * Symbol Digit Modalities Test (SDMT) * RBANS Digit Span forward (Version A) * Wechsler Adult Intelligence Scale III Letter-Number Sequencing test (WAIS-LNS) * Verbal Fluency test (letters S and D) * Grooved Pegboard * Rapid Visual Processing (RVP) test from the Cambridge Neuropsychological Test Automated Battery (CANTAB) using A' (RVP-A) and mean latency for correct responses

  Baseline (only measured once)

Secondary Outcomes (5)

• Cognitive domain scores

  Baseline (only measured once)

• The reduction in gray matter volume in primary somatosensory cortex (S1), primary motor cortex (M1) and hippocampus

  Baseline (only measured once)

• Differences in whiter matter hyperintensities and microbleeds

  Baseline (only measured once)

• Differences in resting state BOLD (Blood oxygenation level dependent) signal

  Baseline (only measured once)

• Differences in BOLD (Blood oxygenation level dependent) signal during n-back memory task

  Baseline (only measured once)

Other Outcomes (3)

• Self-rated health-related quality of life, assessed by Short Form 36 (questionnaire)

  Baseline (only measured once)

• The difference in diabetes distress, assessed by Problem Areas in Diabetes (PAID) 20

  Baseline (only measured once)

• The difference in measured levels of blood-based biomarkers of peripheral and central nerve damage

  Baseline (only measured once)

Study Arms (4)

Type 2 Diabetes and No Neuropathy

This group consists of individuals who meet the inclusion and exclusion criteria and have normal peripheral and cardiovascular autonomic nerve function.

Type 2 Diabetes with Peripheral Neuropathy

This group consists of individuals who meet the inclusion and exclusion criteria and have peripheral neuropathy and normal cardiovascular autonomic nerve function.

Type 2 Diabetes with Cardiovascular Autonomic Neuropathy

This group consists of individuals who meet the inclusion and exclusion criteria and have cardiovascular autonomic neuropathy. They can have a normal or abnormal peripheral nerve test.

Controls (No Type 2 Diabetes)

This group consists of individuals who meet the inclusion and exclusion criteria for controls.

Eligibility Criteria

• Age: 65 Years+
• Gender Eligibility Details: Cisgender people who identify with the gender that aligns with the sex they were assigned at birth.
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Individuals with type 2 diabetes will be recruited among the participants in a former study at teno Diabetes Center Copenhagen, Denmark (DANES-study) who at the time of participation accepted to be contacted again regarding other research projects. Healthy controls will be recruited among persons who have previously participated in studies at SDCC and at the time of participation accepted to be contacted again regarding other research projects. In addition to this, participants will be sought by physical advertisements in the local area, through Facebook groups (all posts that are part of the campaigns, will be created, so it is not possible to comment or tag on them) and through forskningnu.dk.

You may not qualify if:

• 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
• 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.

Sponsors & Collaborators

• Steno Diabetes Center Copenhagen: lead
• Rigshospitalet, Denmark: collaborator

Study Sites (1)

Steno Diabetes Center Copenhagen

Herlev, 2730, Denmark

Location

Biospecimen

Retention: SAMPLES WITH DNA

Samples with DNA: Blood samples (serum, plasma, buffy coat are frozen) Samples without DNA: Urine

MeSH Terms

Conditions

Cognitive Dysfunction; Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 22, 2025
• First Posted: March 5, 2025
• Study Start: March 10, 2025
• Primary Completion: April 23, 2026
• Study Completion: April 23, 2026
• Last Updated: April 29, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)