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

Status: Recruiting
Location: See location...
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 65
Healthy Volunteers: t
View:

⁃ 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

Locations
Other Locations
Denmark
Steno Diabetes Center Copenhagen
RECRUITING
Herlev
Contact Information
Primary
Astrid Wiggers, MD, PhD student
astrid.wiggers@regionh.dk
+45 23 29 92 82
Backup
Jørgen Rungby, MD, DMSc, Professor
joergen.rungby@regionh.dk
+45 21 68 66 20
Time Frame
Start Date: 2025-03-10
Estimated Completion Date: 2026-04
Participants
Target number of participants: 96
Treatments
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.
Sponsors
Leads: Steno Diabetes Center Copenhagen
Collaborators: Rigshospitalet, Denmark

This content was sourced from clinicaltrials.gov