Diabetes Mellitus, Type 2SVT-DNPNCT06519942
Muscle and Bone in Patients with Diabetes Mellitus and Neuropathy
An observational study of Diabetes Mellitus, Type 2 and Diabetic Peripheral Neuropathy, run by University Hospital, Ghent at 1 site in Belgium.
Trial summary
The goal of this observational study is to evaluate muscle fiber type composition in people with type 2 diabetes mellitus (T2DM) with a common complication of T2DM: diabetic peripheral neuropathy (DNP), specifically diabetic sensorimotor polyneuropathy. Read more about this study
- Who is it for?
- Ages 40 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Diabetes Mellitus, Type 2, Diabetic Peripheral Neuropathy, Sarcopenia
- What is being tested?
- Blood sampling, Electromyoneurography (EMNG) and Muscle biopsy
- Type of treatment
- Medical device, Surgery or procedure
- How many people
- 145 participants
- Where
- 1 siteBelgium
- Study dates
- 12 Dec 2023to Nov 2025
- 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 40 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Participants will be recruited through the Ghent University Hospital, diabetes educators and podologists.
Who may be able to join
- All participants:
- Between 40-70 years of age
- BMI between 18,5 - 35 kg/m2
- Persons with T2DM:
- More than 10-year clinical diagnosis of T2DM
Who cannot join
- All participants:
- Possible other causes of nerve impairment (vitamin B12 deficiency, excessive alcohol consumption, chemotherapy)
- Immobilisation (1) > 3 months in past history or (2) > 4 weeks in past 6 months
- Chronic conditions affecting the vital organs (New York Heart Association (NYHA) 3/4, Global Initiative for Obstructive Lung Disease (GOLD) 3/4, cystic fibrosis)
- Hypogonadism
- Inflammatory joint or intestinal diseases
Show all 14Show fewer
- Chronic muscle diseases
- Active malignancy
- Malnutrition disease, eating disorder or bariatric surgery
- Medication use (anticoagulants, glucocorticoids, anti-androgen or anti-estrogen treatment) persons with T2DM:
- Insufficient control of diabetes (HbA1c >9%)
- Healthy controls:
- Fasting glucose > 100 mg/dl
- HbA1c > 5.7 %
Trial locations and contacts
1 site in 1 country.
Belgium1 site, 1 recruiting
- Recruiting
Ghent University Hospital
Ghent, 9000
Cato Van De Looverbosch, 0032479922969, cato.vandelooverbosch@ugent.be
About this study
The goal of this observational study is to evaluate muscle fiber type composition in people with type 2 diabetes mellitus (T2DM) with a common complication of T2DM: diabetic peripheral neuropathy (DNP), specifically diabetic sensorimotor polyneuropathy. Researchers will also look into factors related to DNP: inflammation, the use of energy in the cell, nerve function and the tiny blood vessels in the muscle.
The main question it aims to answer is: Are there differences in muscle fiber type composition between persons with T2DM with and without DNP, in comparison to sex and age-matched healthy peers?
Read more
Participants will partake in the following tests:
- electromyoneurography (EMNG): evaluation of nerve function, damage and repair; for diagnosis of DNP or other diseases of the nerves
- blood analysis: researchers will measure insulin, blood sugar, lipid profile, inflammation
- muscle biopsy in the calf (m. gastrocnemius): a doctor will take a small sample of muscle to evaluate the muscle shape and structure
- mechanography: patients will perform functional tests (e.g. standing up from a chair), researchers will evaluate maximal power and maximal force of the muscles by jumping tests
- questionnaires: on food intake, physical activity, smoking history, alcohol use, medical history
- measurement of height, weight, and the comparison of the hip and waist circumference
- peripheral Quantitative Computed Tomography (pQCT): scan of the calf for muscle density and bone density
- electrocardiography (ECG): evaluation of electrical signals of the heart
Researchers will compare (1) patients with T2DM with DNP, (2) patients with T2DM without DNP, and (3) healthy persons to see if there are differences in muscle fiber type composition
- Being tested
- Blood sampling, Electromyoneurography (EMNG), Muscle biopsy, Quantitative peripheral computed tomography (qPCT), Mechanography
- Medical subject headings
- Diabetes Mellitus, Type 2, Sarcopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood samplingDiagnostic test
Fasting blood samples will be obtained.
Electromyoneurography (EMNG)Diagnostic test
Nerve conduction of sensory and motor nerves of the upper and lower limb will be performed, including F- and H-waves. Needle EMNG of the m. tibialis anterior, m. gastrocnemius (medial head), m. tensor fascia lata and m. gluteus maximus) will be performed.
Muscle biopsyProcedure or surgery
Muscle biopsy of the m. gastrocnemius will be performed under local anesthesia using the modified Bergström technique.
Quantitative peripheral computed tomography (qPCT)Radiation
A qPCT scan of the calf will be performed.
MechanographyDevice
Single two leg jump, multiple one leg hopping, chair rise and sit to stand tests will be performed.
Electrocardiography (ECG)Diagnostic test
A 15-minute resting ECG will be performed.
QuestionnairesOther
Questionnaires will be performed to collect information on medical background (drug use, comorbidities, symptoms of peripheral neuropathy, ...) and lifestyle factors (ethyl consumption, food intake, physical activity, smoking).
AnthropometryOther
Length and hip:waist ratio will be measured. Furthermore, body weight and composition will be determined by bio-impedance measurement. Systolic and diastolic blood pressure (mean of 3 times) will be evaluated.
| Study group | Role | What they receive |
|---|---|---|
| T2DM DNP+ | type 2 diabetes with diabetic neuropathy Receives: Diagnostic Test: Blood sampling; Diagnostic Test: Electromyoneurography (EMNG); Procedure: Muscle biopsy; Radiation: Quantitative peripheral computed tomography (qPCT); Device: Mechanography; Diagnostic Test: Electrocardiography (ECG); Other: Questionnaires; Other: Anthropometry | |
| T2DM DNP- | type 2 diabetes without diabetic neuropathy Receives: Diagnostic Test: Blood sampling; Diagnostic Test: Electromyoneurography (EMNG); Procedure: Muscle biopsy; Radiation: Quantitative peripheral computed tomography (qPCT); Device: Mechanography; Diagnostic Test: Electrocardiography (ECG); Other: Questionnaires; Other: Anthropometry | |
| HC | healthy controls Receives: Diagnostic Test: Blood sampling; Diagnostic Test: Electromyoneurography (EMNG); Procedure: Muscle biopsy; Radiation: Quantitative peripheral computed tomography (qPCT); Device: Mechanography; Diagnostic Test: Electrocardiography (ECG); Other: Questionnaires; Other: Anthropometry |
What is being measured
The primary outcome is the main question the study is designed to answer.
Differences in muscle fiber type composition in persons with type 2 diabetes with diabetic peripheral neuropathy compared to persons with type 2 diabetes without diabetic neuropathy and healthy controls.
Differences in muscle fiber type distribution, percentage and cross-sectional area will be evaluated through myosin heavy chain (MHC) immunostaining of the muscle specimen.
Measured: At enrollment
Secondary outcomes (11)
Differences in nerve conduction velocity in persons with type 2 diabetes with diabetic peripheral neuropathy compared to persons with type 2 diabetes without diabetic neuropathy and healthy controls
Nerve conduction velocity will be examined through EMNG examination to examine neuromotor function
Measured: At enrollment
Differences in capillarization in persons with type 2 diabetes with diabetic peripheral neuropathy compared to persons with type 2 diabetes without diabetic neuropathy and healthy controls.
Capillarization will be examined through histological examination of the muscle specimen using Ulex europaeus I (UEA-I) staining.
Measured: At enrollment
Differences in electron microscopic properties assessing mitochondrial function in persons with type 2 diabetes with diabetic peripheral neuropathy compared to persons with type 2 diabetes without diabetic neuropathy and healthy controls
Mitochondrial function will be examined through electron microscopy of the muscle specimen.
Measured: At enrollment
Differences in maximal force in persons with type 2 diabetes with diabetic peripheral neuropathy compared to persons with type 2 diabetes without diabetic neuropathy and healthy controls.
Maximal force will be evaluated using mechanography through multiple one leg hopping.
Measured: At enrollment
Differences in maximal power in persons with type 2 diabetes with diabetic peripheral neuropathy compared to persons with type 2 diabetes without diabetic neuropathy and healthy controls.
Maximal power will be evaluated using mechanography through the single two leg jump.
Measured: At enrollment
Differences in functional muscle strength in persons with type 2 diabetes with diabetic peripheral neuropathy compared to persons with type 2 diabetes without diabetic neuropathy and healthy controls.
Functional strength will be examined using mechanography through the chair rising test and heel rise test.
Measured: At enrollment
Differences in physical activity levels in persons with type 2 diabetes with diabetic peripheral neuropathy compared to persons with type 2 diabetes without diabetic neuropathy and healthy controls.
Differences in the lifestyle factor physical activity will be examined through the International Physical Activity Questionnaire (IPAQ) - Long Form).
Measured: At enrollment
Differences in food intake in persons with type 2 diabetes with diabetic peripheral neuropathy compared to persons with type 2 diabetes without diabetic neuropathy and healthy controls.
Differences in the lifestyle factor food intake will be examined through a food frequency questionnaire.
Measured: At enrollment
Differences in lifestyle factors in persons with type 2 diabetes with diabetic peripheral neuropathy compared to persons with type 2 diabetes without diabetic neuropathy and healthy controls.
Differences in lifestyle factors smoking and ethyl consumption will be examined through non-official questionnaires.
Measured: At enrollment
Differences in muscle density in persons with type 2 diabetes with diabetic peripheral neuropathy compared to persons with type 2 diabetes without diabetic neuropathy and healthy controls.
Differences in muscle density will be evaluated through pQCT of the calf.
Measured: At enrollment
Differences in bone density in persons with type 2 diabetes with diabetic peripheral neuropathy compared to persons with type 2 diabetes without diabetic neuropathy and healthy controls.
Differences in bone density will be evaluated through pQCT of the calf.
Measured: At enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2024
- Study start12 Dec 2023
- Primary completionNov 2025 (estimated)
- Study completionNov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- More trials run by University Hospital, GhentThe sponsor's other registered studies.
- 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
- 145 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Ghent
- Sponsor type
- University, hospital or other
- Collaborators
- University Ghent
- Responsible party
- Sponsor
- Investigators
- Bruno Lapauw, Principal investigator, University Hospital, Ghent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06519942
- Sponsor's protocol ID
- ONZ-2023-0120
- Other IDs
- BOF.24Y.2023.0030.01
- Acronym
- SVT-DNP
- Status last verified
- Sep 2024
- First submitted
- 10 Apr 2024
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: After publication, anonymous individual participant data can be made available to other researchers upon request.
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Muscle and Bone in Patients with Diabetes Mellitus and Neuropathy
- ClinicalTrials.gov ID
- NCT06519942
- Acronym / sponsor ID
- SVT-DNP / ONZ-2023-0120
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 145 participants (estimated)
- Lead sponsor
- University Hospital, GhentUniversity, hospital or other
- Collaborators
- University Ghent
- Study start
- 12 Dec 2023 (actual)
- Primary completion
- Nov 2025 (estimated)
- Study completion
- Nov 2025 (estimated)
- First posted
- 25 Jul 2024 (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 muscle fiber type composition in people with type 2 diabetes mellitus (T2DM) with a common complication of T2DM: diabetic peripheral neuropathy (DNP), specifically diabetic sensorimotor polyneuropathy. Researchers will also look into factors related to DNP: inflammation, the use of energy in the cell, nerve function and the tiny blood vessels in the muscle.
The main question it aims to answer is: Are there differences in muscle fiber type composition between persons with T2DM with and without DNP, in comparison to sex and age-matched healthy peers?
Participants will partake in the following tests:
- electromyoneurography (EMNG): evaluation of nerve function, damage and repair; for diagnosis of DNP or other diseases of the nerves
- blood analysis: researchers will measure insulin, blood sugar, lipid profile, inflammation
- muscle biopsy in the calf (m. gastrocnemius): a doctor will take a small sample of muscle to evaluate the muscle shape and structure
- mechanography: patients will perform functional tests (e.g. standing up from a chair), researchers will evaluate maximal power and maximal force of the muscles by jumping tests
- questionnaires: on food intake, physical activity, smoking history, alcohol use, medical history
- measurement of height, weight, and the comparison of the hip and waist circumference
- peripheral Quantitative Computed Tomography (pQCT): scan of the calf for muscle density and bone density
- electrocardiography (ECG): evaluation of electrical signals of the heart
Researchers will compare (1) patients with T2DM with DNP, (2) patients with T2DM without DNP, and (3) healthy persons to see if there are differences in muscle fiber type composition
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| T2DM DNP+ | – | Diagnostic Test: Blood sampling, Diagnostic Test: Electromyoneurography (EMNG), Procedure: Muscle biopsy, Radiation: Quantitative peripheral computed tomography (qPCT), Device: Mechanography, Diagnostic Test: Electrocardiography (ECG), Other: Questionnaires, Other: Anthropometrytype 2 diabetes with diabetic neuropathy |
| T2DM DNP- | – | Diagnostic Test: Blood sampling, Diagnostic Test: Electromyoneurography (EMNG), Procedure: Muscle biopsy, Radiation: Quantitative peripheral computed tomography (qPCT), Device: Mechanography, Diagnostic Test: Electrocardiography (ECG), Other: Questionnaires, Other: Anthropometrytype 2 diabetes without diabetic neuropathy |
| HC | – | Diagnostic Test: Blood sampling, Diagnostic Test: Electromyoneurography (EMNG), Procedure: Muscle biopsy, Radiation: Quantitative peripheral computed tomography (qPCT), Device: Mechanography, Diagnostic Test: Electrocardiography (ECG), Other: Questionnaires, Other: Anthropometryhealthy controls |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Participants will be recruited through the Ghent University Hospital, diabetes educators and podologists.
Key inclusion criteria (5 listed)
- Between 40-70 years of age
- BMI between 18,5 - 35 kg/m2
- More than 10-year clinical diagnosis of T2DM
Key exclusion criteria (14 listed)
- Possible other causes of nerve impairment (vitamin B12 deficiency, excessive alcohol consumption, chemotherapy)
- Immobilisation (1) > 3 months in past history or (2) > 4 weeks in past 6 months
- Chronic conditions affecting the vital organs (New York Heart Association (NYHA) 3/4, Global Initiative for Obstructive Lung Disease (GOLD) 3/4, cystic fibrosis)
- Hypogonadism
- Inflammatory joint or intestinal diseases
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood samplingFasting blood samples will be obtained. | Diagnostic test | HC, T2DM DNP+, T2DM DNP- |
| Electromyoneurography (EMNG)Nerve conduction of sensory and motor nerves of the upper and lower limb will be performed, including F- and H-waves. Needle EMNG of the m. tibialis anterior, m. gastrocnemius (medial head), m. tensor fascia lata and m. gluteus maximus) will be performed. | Diagnostic test | HC, T2DM DNP+, T2DM DNP- |
| Muscle biopsyMuscle biopsy of the m. gastrocnemius will be performed under local anesthesia using the modified Bergström technique. | Procedure or surgery | HC, T2DM DNP+, T2DM DNP- |
| Quantitative peripheral computed tomography (qPCT)A qPCT scan of the calf will be performed. | Radiation | HC, T2DM DNP+, T2DM DNP- |
| MechanographySingle two leg jump, multiple one leg hopping, chair rise and sit to stand tests will be performed. | Device | HC, T2DM DNP+, T2DM DNP- |
| Electrocardiography (ECG)A 15-minute resting ECG will be performed. | Diagnostic test | HC, T2DM DNP+, T2DM DNP- |
| QuestionnairesQuestionnaires will be performed to collect information on medical background (drug use, comorbidities, symptoms of peripheral neuropathy, ...) and lifestyle factors (ethyl consumption, food intake, physical activity, smoking). | Other | HC, T2DM DNP+, T2DM DNP- |
| AnthropometryLength and hip:waist ratio will be measured. Furthermore, body weight and composition will be determined by bio-impedance measurement. Systolic and diastolic blood pressure (mean of 3 times) will be evaluated. | Other | HC, T2DM DNP+, T2DM DNP- |
Primary outcome
Differences in muscle fiber type composition in persons with type 2 diabetes with diabetic peripheral neuropathy compared to persons with type 2 diabetes without diabetic neuropathy and healthy controls.
Time frame: At enrollment
Differences in muscle fiber type distribution, percentage and cross-sectional area will be evaluated through myosin heavy chain (MHC) immunostaining of the muscle specimen.
11 secondary outcomes
Differences in nerve conduction velocity in persons with type 2 diabetes with diabetic peripheral neuropathy compared to persons with type 2 diabetes without diabetic neuropathy and healthy controls
Time frame: At enrollment
Differences in capillarization in persons with type 2 diabetes with diabetic peripheral neuropathy compared to persons with type 2 diabetes without diabetic neuropathy and healthy controls.
Time frame: At enrollment
Differences in electron microscopic properties assessing mitochondrial function in persons with type 2 diabetes with diabetic peripheral neuropathy compared to persons with type 2 diabetes without diabetic neuropathy and healthy controls
Time frame: At enrollment
Differences in maximal force in persons with type 2 diabetes with diabetic peripheral neuropathy compared to persons with type 2 diabetes without diabetic neuropathy and healthy controls.
Time frame: At enrollment
Differences in maximal power in persons with type 2 diabetes with diabetic peripheral neuropathy compared to persons with type 2 diabetes without diabetic neuropathy and healthy controls.
Time frame: At enrollment
Differences in functional muscle strength in persons with type 2 diabetes with diabetic peripheral neuropathy compared to persons with type 2 diabetes without diabetic neuropathy and healthy controls.
Time frame: At enrollment
Differences in physical activity levels in persons with type 2 diabetes with diabetic peripheral neuropathy compared to persons with type 2 diabetes without diabetic neuropathy and healthy controls.
Time frame: At enrollment
Differences in food intake in persons with type 2 diabetes with diabetic peripheral neuropathy compared to persons with type 2 diabetes without diabetic neuropathy and healthy controls.
Time frame: At enrollment
Differences in lifestyle factors in persons with type 2 diabetes with diabetic peripheral neuropathy compared to persons with type 2 diabetes without diabetic neuropathy and healthy controls.
Time frame: At enrollment
Differences in muscle density in persons with type 2 diabetes with diabetic peripheral neuropathy compared to persons with type 2 diabetes without diabetic neuropathy and healthy controls.
Time frame: At enrollment
Differences in bone density in persons with type 2 diabetes with diabetic peripheral neuropathy compared to persons with type 2 diabetes without diabetic neuropathy and healthy controls.
Time frame: At enrollment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Individual participant dataSharing planned: Yes. After publication, anonymous individual participant data can be made available to other researchers upon request.
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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.
Bruno Lapauw principal investigator
University Hospital, Ghent
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 Diabetes Mellitus, Type 2 and Diabetic Peripheral Neuropathy, run by University Hospital, Ghent at 1 site in Belgium.
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 5 inclusion and 14 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: status not confirmed, as of the sponsor's last update on 19 Sep 2024. 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 Belgium. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Cato Van De Looverbosch (0479922969, cato.vandelooverbosch@ugent.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Differences in muscle fiber type composition in persons with type 2 diabetes with diabetic peripheral neuropathy compared to persons with type 2 diabetes without diabetic neuropathy and healthy controls. (time frame: At enrollment). 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 19 Sep 2024.