Chronic Kidney Disease Stage 3 and 4PredictNPNCT06933108
Prediction of Peripheral Neuropathy With Functional Testing
An observational study of Chronic Kidney Disease Stage 3 and 4 and Diabetes, run by Université catholique de l'Ouest at 1 site in France.
Trial summary
Diabetes and chronic kidney disease (CKD) are two distinct pathologies. The former is defined as an impairment in insulin production and/or utilization, while the latter refers to structural or functional abnormalities of the kidneys. However, these two diseases share a common complication: peripheral neuropathy. Read more about this study
- Who is it for?
- Ages 60 to 80 years
- Conditions the study is for
- Chronic Kidney Disease Stage 3 and 4, Diabetes
- How many people
- 70 participants
- Where
- 1 siteFrance
- Study dates
- 27 Jan 2025to 2 May 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 60 to 80 years
- All sexes
- Adult, Older adult
Study population: Le Mans Hospital, from nephrology and endocrinology unit
Who may be able to join
- CKD stage 4-5 and / or diabetes (Type I or II)
- Able to walk 20 m
- BMI < 35
Who cannot join
- Currently or planning dialysis
- Musculoskeletal, osteorarticular and neurological disease(s)
- Cognitive impairment
- Low-limb amputation
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Centre Hospitalier Le Mans
Le Mans, 72000
Giorgina Barbara Piccoli, Professor, Medical Doctor, 0243434343 ext. +33, gpiccoli@ch-lemans.fr
About this study
Official title: Estimate the Risk of Diabetic and Uremic Peripheral Neuropathy Using Physical and Functional Testing
Diabetes and chronic kidney disease (CKD) are two distinct pathologies. The former is defined as an impairment in insulin production and/or utilization, while the latter refers to structural or functional abnormalities of the kidneys. However, these two diseases share a common complication: peripheral neuropathy. This condition affects between 50% and 60% of patients with diabetes or CKD.
Peripheral neuropathy involves the destruction of sensory and motor neurons, leading to a wide range of painful symptoms while also reducing force production capacity. Among the diagnostic tests used, the most accessible clinical tests suffer from high variability due to human subjectivity (e.g., the tuning fork test, which requires examiner expertise and verbal patient feedback), whereas laboratory electrophysiological tests can only detect the largest neurons, which are affected at later stages. Although composite clinical tests have been developed to improve neuropathy screening performance, they still inherit the limitations of their individual components. In other words, they remain subject to variability related to the examiner's experience and the patient's ability to understand instructions, while also being performed through various procedures that lack a standardized consensus. Moreover, these composite scores are particularly time-consuming and are therefore rarely used in clinical practice. As a result, no method currently allows for large-scale, early, and reliable screening of peripheral neuropathy.
Read more
Our recent work and emerging studies suggest that assessing functional capacities could serve as an objective and early marker of neuropathic impairment, even before clinical diagnosis. Specifically, the quantification of postural balance performance using stabilometric methods (i.e., center of pressure displacement area) and unipedal balance time could predict the presence of diabetes-related peripheral neuropathy with over 95% accuracy compared to diagnosis with a composite clinical method (unpublished results).
Therefore, the aim of this study is to evaluate physical and balance capacities assessed during routine care in adapted physical activity settings, in order to determine whether the development of a composite score could help estimate the risk of peripheral neuropathy in individuals with diabetes and CKD.
- Conditions
- Chronic Kidney Disease Stage 3 and 4, Diabetes
- Medical subject headings
- Renal Insufficiency, Chronic, Diabetes Mellitus
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite score derived from the statistical model
The composite score will be built with the performances at the functional tests (independant variables) using a logistic backward regression model, to predict peripheral neuropathy (dependant variable: yes or no). The score will range from 0 to 1. Higher is the score, higher is the risk of peripheral neuropathy.
Dependant variables: Michigan Neuropathy Screening Instrument, to diagnosis peripheral neuropathy.
Independant variables: Maximal dorsiflexion and plantar flexion of the ankle, maximal hallux flexion, 10-meter walking test (speed, cadence), postural balance, Timed-up and Go, and two proprioceptive tests (Joint Position Sense and the Star Excursion Balance Test).
Measured: Transversal study : At baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2025
- Study start27 Jan 2025
- Primary completion2 May 2025 (estimated)
- Study completion2 May 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Kidney Disease Stage 3 and 4Studies 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 only
- Time perspective
- Prospective
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Université catholique de l'Ouest
- Sponsor type
- University, hospital or other
- Collaborators
- Centre Hospitalier le Mans, Le Mans Universite
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06933108
- Sponsor's protocol ID
- UCO20250326
- Acronym
- PredictNP
- Status last verified
- Apr 2025
- First submitted
- 26 Mar 2025
- Last updated
- 18 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided: Because the power of the prediciton will be based on the data. So the data cannot be shared before publication.
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Estimate the Risk of Diabetic and Uremic Peripheral Neuropathy Using Physical and Functional Testing
- ClinicalTrials.gov ID
- NCT06933108
- Acronym / sponsor ID
- PredictNP / UCO20250326
- Conditions
- Chronic Kidney Disease Stage 3 and 4, Diabetes
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Université catholique de l'OuestUniversity, hospital or other
- Collaborators
- Centre Hospitalier le Mans, Le Mans Universite
- Study start
- 27 Jan 2025 (actual)
- Primary completion
- 2 May 2025 (estimated)
- Study completion
- 2 May 2025 (estimated)
- First posted
- 18 Apr 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.
Diabetes and chronic kidney disease (CKD) are two distinct pathologies. The former is defined as an impairment in insulin production and/or utilization, while the latter refers to structural or functional abnormalities of the kidneys. However, these two diseases share a common complication: peripheral neuropathy. This condition affects between 50% and 60% of patients with diabetes or CKD.
Peripheral neuropathy involves the destruction of sensory and motor neurons, leading to a wide range of painful symptoms while also reducing force production capacity. Among the diagnostic tests used, the most accessible clinical tests suffer from high variability due to human subjectivity (e.g., the tuning fork test, which requires examiner expertise and verbal patient feedback), whereas laboratory electrophysiological tests can only detect the largest neurons, which are affected at later stages. Although composite clinical tests have been developed to improve neuropathy screening performance, they still inherit the limitations of their individual components. In other words, they remain subject to variability related to the examiner's experience and the patient's ability to understand instructions, while also being performed through various procedures that lack a standardized consensus. Moreover, these composite scores are particularly time-consuming and are therefore rarely used in clinical practice. As a result, no method currently allows for large-scale, early, and reliable screening of peripheral neuropathy.
Our recent work and emerging studies suggest that assessing functional capacities could serve as an objective and early marker of neuropathic impairment, even before clinical diagnosis. Specifically, the quantification of postural balance performance using stabilometric methods (i.e., center of pressure displacement area) and unipedal balance time could predict the presence of diabetes-related peripheral neuropathy with over 95% accuracy compared to diagnosis with a composite clinical method (unpublished results).
Therefore, the aim of this study is to evaluate physical and balance capacities assessed during routine care in adapted physical activity settings, in order to determine whether the development of a composite score could help estimate the risk of peripheral neuropathy in individuals with diabetes and CKD.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 60 to 80 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Le Mans Hospital, from nephrology and endocrinology unit
Key inclusion criteria (3 listed)
- CKD stage 4-5 and / or diabetes (Type I or II)
- Able to walk 20 m
- BMI < 35
Key exclusion criteria (4 listed)
- Currently or planning dialysis
- Musculoskeletal, osteorarticular and neurological disease(s)
- Cognitive impairment
- Low-limb amputation
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
Composite score derived from the statistical model
Time frame: Transversal study : At baseline
The composite score will be built with the performances at the functional tests (independant variables) using a logistic backward regression model, to predict peripheral neuropathy (dependant variable: yes or no). The score will range from 0 to 1. Higher is the score, higher is the risk of peripheral neuropathy. Dependant variables: Michigan Neuropathy Screening Instrument, to diagnosis peripheral neuropathy. Independant variables: Maximal dorsiflexion and plantar flexion of the ankle, maximal hallux flexion, 10-meter walking test (speed, cadence), postural balance, Timed-up and Go, and two proprioceptive tests (Joint Position Sense and the Star Excursion Balance Test).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2025.
- Individual participant dataSharing planned: Undecided. Because the power of the prediciton will be based on the data. So the data cannot be shared before publication.
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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.
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 Chronic Kidney Disease Stage 3 and 4 and Diabetes, run by Université catholique de l'Ouest at 1 site in France.
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 3 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 18 Apr 2025. 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 France. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Giorgina Barbara Piccoli, Professor, Medical Doctor (0243434343 ext. +33, gpiccoli@ch-lemans.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Composite score derived from the statistical model (time frame: Transversal study : At baseline). 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 18 Apr 2025.