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| ID | Type | Description | Link |
|---|---|---|---|
| BOF.24Y.2023.0030.01 | Other Grant/Funding Number | Special Research Fund (Ghent University) |
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| Name | Class |
|---|---|
| University Ghent | OTHER |
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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:
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| T2DM DNP+ | type 2 diabetes with diabetic neuropathy |
| |
| T2DM DNP- | type 2 diabetes without diabetic neuropathy |
| |
| HC | healthy controls |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Blood sampling | Diagnostic Test | Fasting blood samples will be obtained. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | At enrollment |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | At enrollment |
| Measure | Description | Time Frame |
|---|---|---|
| Differences in heart rate variability in persons with type 2 diabetes with diabetic peripheral neuropathy compared to persons with type 2 diabetes without diabetic neuropathy and healthy controls. | Heart rate variability will be examined through a 15-minute resting ECG. | At enrollment |
| Differences in interleukin 6 (IL-6) concentration in persons with type 2 diabetes with diabetic peripheral neuropathy compared to persons with type 2 diabetes without diabetic neuropathy and healthy controls. |
Inclusion Criteria:
All participants:
Persons with T2DM:
Exclusion Criteria:
All participants:
Healthy controls:
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Participants will be recruited through the Ghent University Hospital, diabetes educators and podologists.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Cato Van De Looverbosch | Contact | 0479922969 | cato.vandelooverbosch@ugent.be |
| Name | Affiliation | Role |
|---|---|---|
| Bruno Lapauw | University Hospital, Ghent | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ghent University Hospital | Recruiting | Ghent | 9000 | Belgium |
After publication, anonymous individual participant data can be made available to other researchers upon request.
After publication
Upon request to corresponding author
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blood sample, muscle biopsy sample
| 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 biopsy | Procedure | Muscle biopsy of the m. gastrocnemius will be performed under local anesthesia using the modified Bergström technique. |
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| Quantitative peripheral computed tomography (qPCT) | Radiation | A qPCT scan of the calf will be performed. |
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| Mechanography | Device | Single two leg jump, multiple one leg hopping, chair rise and sit to stand tests will be performed. |
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| Electrocardiography (ECG) | Diagnostic Test | A 15-minute resting ECG will be performed. |
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| Questionnaires | Other | 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). |
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| Anthropometry | Other | 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. |
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| 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. |
| 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. | 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. | 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. | 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. | 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). | 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. | 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. | 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. | 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. | At enrollment |
Differences in inflammation will be evaluated through blood analysis of IL-6. |
| At enrollment |
| Differences in tumor necrosis factor alpha (TNFα) concentration 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 inflammation will be evaluated through blood analysis of TNFα. | At enrollment |
| Differences in C-reactive protein (CRP) concentration 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 inflammation will be evaluated through blood analysis of CRP. | At enrollment |
| Differences in mononuclear cell numbers 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 inflammation will be evaluated through flow cytometry to assess mononuclear cell numbers. | At enrollment |
| Differences in protein concentrations for AMPK and PGC-1α 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 protein concentrations for 5' adenosine monophosphate-activated protein kinase (AMPK) and peroxisome proliferator-activated receptor-gamma coactivator 1 alpha (PGC-1α) will be examined using western blotting (on the muscle sample) | At enrollment |
| Differences in citrate synthase activity in persons with type 2 diabetes with diabetic peripheral neuropathy compared to persons with type 2 diabetes without diabetic neuropathy and healthy controls | Citrate synthase activity will be examined using an activity assay (on the muscle sample). | At enrollment |
| Differences in succinate dehydrogenase B (SDHB) expression in persons with type 2 diabetes with diabetic peripheral neuropathy compared to persons with type 2 diabetes without diabetic neuropathy and healthy controls | SDHB expression will be examined through immunohistochemical staining for SDHB of the muscle specimen. | At enrollment |
| Differences in vascular endothelial growth factor (VEGF) concentrations in persons with type 2 diabetes with diabetic peripheral neuropathy compared to persons with type 2 diabetes without diabetic neuropathy and healthy controls. | Vascular endothelial growth factor concentrations will be examined through blood analysis. | At enrollment |
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D055948 | Sarcopenia |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D009133 | Muscular Atrophy |
| D020879 | Neuromuscular Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D001284 | Atrophy |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012816 | Signs and Symptoms |
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| ID | Term |
|---|---|
| D001800 | Blood Specimen Collection |
| D004562 | Electrocardiography |
| D011795 | Surveys and Questionnaires |
| D000886 | Anthropometry |
| ID | Term |
|---|---|
| D013048 | Specimen Handling |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D011677 | Punctures |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |
| D006334 | Heart Function Tests |
| D003935 | Diagnostic Techniques, Cardiovascular |
| D004568 | Electrodiagnosis |
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D017531 | Health Care Evaluation Mechanisms |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |
| D010808 | Physical Examination |
| D001699 | Biometry |
| D015991 | Epidemiologic Measurements |
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