Muscle and Bone in Patients with Diabetes Mellitus and Neuropathy
NCT ID: NCT06519942
Last Updated: 2024-09-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
145 participants
OBSERVATIONAL
2023-12-12
2025-11-30
Brief Summary
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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
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Detailed Description
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Conditions
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Study Design
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CASE_CONTROL
CROSS_SECTIONAL
Study Groups
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T2DM DNP+
type 2 diabetes with diabetic neuropathy
Blood sampling
Fasting blood samples will be obtained.
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.
Muscle biopsy
Muscle biopsy of the m. gastrocnemius will be performed under local anesthesia using the modified Bergström technique.
Quantitative peripheral computed tomography (qPCT)
A qPCT scan of the calf will be performed.
Mechanography
Single two leg jump, multiple one leg hopping, chair rise and sit to stand tests will be performed.
Electrocardiography (ECG)
A 15-minute resting ECG will be performed.
Questionnaires
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).
Anthropometry
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.
T2DM DNP-
type 2 diabetes without diabetic neuropathy
Blood sampling
Fasting blood samples will be obtained.
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.
Muscle biopsy
Muscle biopsy of the m. gastrocnemius will be performed under local anesthesia using the modified Bergström technique.
Quantitative peripheral computed tomography (qPCT)
A qPCT scan of the calf will be performed.
Mechanography
Single two leg jump, multiple one leg hopping, chair rise and sit to stand tests will be performed.
Electrocardiography (ECG)
A 15-minute resting ECG will be performed.
Questionnaires
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).
Anthropometry
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.
HC
healthy controls
Blood sampling
Fasting blood samples will be obtained.
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.
Muscle biopsy
Muscle biopsy of the m. gastrocnemius will be performed under local anesthesia using the modified Bergström technique.
Quantitative peripheral computed tomography (qPCT)
A qPCT scan of the calf will be performed.
Mechanography
Single two leg jump, multiple one leg hopping, chair rise and sit to stand tests will be performed.
Electrocardiography (ECG)
A 15-minute resting ECG will be performed.
Questionnaires
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).
Anthropometry
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.
Interventions
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Blood sampling
Fasting blood samples will be obtained.
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.
Muscle biopsy
Muscle biopsy of the m. gastrocnemius will be performed under local anesthesia using the modified Bergström technique.
Quantitative peripheral computed tomography (qPCT)
A qPCT scan of the calf will be performed.
Mechanography
Single two leg jump, multiple one leg hopping, chair rise and sit to stand tests will be performed.
Electrocardiography (ECG)
A 15-minute resting ECG will be performed.
Questionnaires
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).
Anthropometry
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.
Eligibility Criteria
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Inclusion Criteria
* Between 40-70 years of age
* BMI between 18,5 - 35 kg/m2
Persons with T2DM:
* More than 10-year clinical diagnosis of T2DM
Exclusion Criteria
* 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
* 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 %
40 Years
70 Years
ALL
Yes
Sponsors
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University Ghent
OTHER
University Hospital, Ghent
OTHER
Responsible Party
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Principal Investigators
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Bruno Lapauw
Role: PRINCIPAL_INVESTIGATOR
University Hospital, Ghent
Locations
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Ghent University Hospital
Ghent, , Belgium
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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BOF.24Y.2023.0030.01
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
ONZ-2023-0120
Identifier Type: -
Identifier Source: org_study_id
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