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RECRUITINGOBSERVATIONAL

Muscle and Bone in Patients with Diabetes Mellitus and Neuropathy

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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

Who May Be Eligible (Plain English)

Who May Qualify: 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 Should NOT Join This Trial: 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 - 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 % Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
Inclusion Criteria: 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 Exclusion Criteria: 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 * 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 %

Treatments Being Tested

DIAGNOSTIC_TEST

Blood sampling

Fasting blood samples will be obtained.

DIAGNOSTIC_TEST

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.

PROCEDURE

Muscle biopsy

Muscle biopsy of the m. gastrocnemius will be performed under local anesthesia using the modified Bergström technique.

RADIATION

Quantitative peripheral computed tomography (qPCT)

A qPCT scan of the calf will be performed.

DEVICE

Mechanography

Single two leg jump, multiple one leg hopping, chair rise and sit to stand tests will be performed.

DIAGNOSTIC_TEST

Electrocardiography (ECG)

A 15-minute resting ECG will be performed.

OTHER

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).

OTHER

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.

Locations (1)

Ghent University Hospital
Ghent, Belgium