Peripheral Diabetic NeuropathyASCENDNCT06857994
The Association Between Cognitive Function and Neuropathy in Individuals With Type 2 Diabetes
An observational study of Peripheral Diabetic Neuropathy and Cardiovascular Autonomic Neuropathy, run by Steno Diabetes Center Copenhagen at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Peripheral Diabetic Neuropathy, Cardiovascular Autonomic Neuropathy, Cognitive Impairment
- How many people
- 101 participants
- Where
- 1 siteDenmark
- Study dates
- 10 Mar 2025to 23 Apr 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
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.
Who may be able to join
- 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)
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- 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
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Association Between Cognitive Function and Diabetic Neuropathy in Individuals With Type 2 Diabetes
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.
Read the detailed description
Type 2 diabetes (T2D) is a chronic disease with complications that affect various organs over time. While certain complications have been well- established for decades, recent research points to the brain as an important site of diabetes-associated damage. This aligns with the growing awareness of the cognitive impact of diabetes. Diabetes is associated with mild to moderate alterations in cognitive functions across diverse age groups and an increased risk of developing dementia. The precise mechanism underlying these associations remains elusive, but some studies suggest that impaired peripheral nerve function correlates with negative cognitive outcomes and may be associated with structural and functional brain changes. Since diabetic neuropathy is one of the most common complications of diabetes, it might contribute to an increased dementia risk.
ASCEND is a clinical descriptive study that aims to evaluate the association between diabetic neuropathy and cognitive function in individuals with type 2 diabetes (compared to controls without diabetes). The study comprises the following visits:
- Screening visit
- Neuropathy assessment and neuropsychological testing visit
- Structural and functional MRI (only a subset of participants)
The neuropathy assessment will include the following measures:
- Peripheral vibration sensation (biothesiometer)
- Cardiovascular autonomic neuropathy (Vagus device) both resting heart rate variability and cardiovascular reflex tests
- Nerve conduction velocity and amplitude of the Sural nerves by DPN-check
- Light touch and pain sensation (10 g monofilament and 40g needle)
- Peripheral small-fiber sympathetic function (Sudoscan device)
- Cold and warm sensation of foot and lower leg
The neuropsychological test 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
- Conditions
- Peripheral Diabetic Neuropathy, Cardiovascular Autonomic Neuropathy, Cognitive Impairment, Diabetes Type 2
- Medical subject headings
- Cognitive Dysfunction, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Baseline (only measured once)
Secondary outcomes (5)
Cognitive domain scores
The cognitive domain scores are based on the scores from the neuropsychological test battery. The cognitive domain 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
Measured: Baseline (only measured once)
The reduction in gray matter volume in primary somatosensory cortex (S1), primary motor cortex (M1) and hippocampus
Structural brain MRI
Measured: Baseline (only measured once)
Differences in whiter matter hyperintensities and microbleeds
Structural brain MRI
Measured: Baseline (only measured once)
Differences in resting state BOLD (Blood oxygenation level dependent) signal
Functional brain MRI
Measured: Baseline (only measured once)
Differences in BOLD (Blood oxygenation level dependent) signal during n-back memory task
Functional MRI
Measured: Baseline (only measured once)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2025
- Study start10 Mar 2025
- Primary completion23 Apr 2026
- Study completion23 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripheral Diabetic NeuropathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 101 participants (actual)
Sponsor and investigators
- Lead sponsor
- Steno Diabetes Center Copenhagen
- Sponsor type
- University, hospital or other
- Collaborators
- Copenhagen University Hospital, Rigshospitalet
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06857994
- Sponsor's protocol ID
- H-24014649
- Acronym
- ASCEND
- Status last verified
- Apr 2026
- First submitted
- 22 Jan 2025
- Last updated
- 29 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Association Between Cognitive Function and Diabetic Neuropathy in Individuals With Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT06857994
- Acronym / sponsor ID
- ASCEND / H-24014649
- Conditions
- Peripheral Diabetic Neuropathy, Cardiovascular Autonomic Neuropathy, Cognitive Impairment, Diabetes Type 2
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 101 participants (actual)
- Lead sponsor
- Steno Diabetes Center CopenhagenUniversity, hospital or other
- Collaborators
- Copenhagen University Hospital, Rigshospitalet
- Study start
- 10 Mar 2025 (actual)
- Primary completion
- 23 Apr 2026 (actual)
- Study completion
- 23 Apr 2026 (actual)
- First posted
- 5 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Type 2 diabetes (T2D) is a chronic disease with complications that affect various organs over time. While certain complications have been well- established for decades, recent research points to the brain as an important site of diabetes-associated damage. This aligns with the growing awareness of the cognitive impact of diabetes. Diabetes is associated with mild to moderate alterations in cognitive functions across diverse age groups and an increased risk of developing dementia. The precise mechanism underlying these associations remains elusive, but some studies suggest that impaired peripheral nerve function correlates with negative cognitive outcomes and may be associated with structural and functional brain changes. Since diabetic neuropathy is one of the most common complications of diabetes, it might contribute to an increased dementia risk.
ASCEND is a clinical descriptive study that aims to evaluate the association between diabetic neuropathy and cognitive function in individuals with type 2 diabetes (compared to controls without diabetes). The study comprises the following visits:
- Screening visit
- Neuropathy assessment and neuropsychological testing visit
- Structural and functional MRI (only a subset of participants)
The neuropathy assessment will include the following measures:
- Peripheral vibration sensation (biothesiometer)
- Cardiovascular autonomic neuropathy (Vagus device) both resting heart rate variability and cardiovascular reflex tests
- Nerve conduction velocity and amplitude of the Sural nerves by DPN-check
- Light touch and pain sensation (10 g monofilament and 40g needle)
- Peripheral small-fiber sympathetic function (Sudoscan device)
- Cold and warm sensation of foot and lower leg
The neuropsychological test 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
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
- 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.
Key inclusion criteria (13 listed)
- 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)
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Cognitive composite score (global score)
Time frame: Baseline (only measured once)
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
5 secondary outcomes
Cognitive domain scores
Time frame: Baseline (only measured once)
The reduction in gray matter volume in primary somatosensory cortex (S1), primary motor cortex (M1) and hippocampus
Time frame: Baseline (only measured once)
Differences in whiter matter hyperintensities and microbleeds
Time frame: Baseline (only measured once)
Differences in resting state BOLD (Blood oxygenation level dependent) signal
Time frame: Baseline (only measured once)
Differences in BOLD (Blood oxygenation level dependent) signal during n-back memory task
Time frame: Baseline (only measured once)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Peripheral Diabetic Neuropathy and Cardiovascular Autonomic Neuropathy, run by Steno Diabetes Center Copenhagen at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cognitive composite score (global score) (time frame: Baseline (only measured once)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2026.