RecruitingNCT06519942

Muscle and Bone in Patients with Diabetes Mellitus and Neuropathy

Sponsor

University Hospital, Ghent

Enrollment

145 participants

Start Date

Dec 12, 2023

Study Type

OBSERVATIONAL

Conditions

Sarcopenia Diabetes Mellitus, Type 2 Diabetic Peripheral Neuropathy

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. 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

Eligibility

Min Age: 40 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This study is investigating how type 2 diabetes and nerve damage (diabetic neuropathy) affect muscle and bone health in adults, by comparing people with long-standing diabetes to healthy individuals. **You may be eligible if...** - You are between 40 and 70 years old - Your BMI is between 18.5 and 35 - If you have type 2 diabetes: you have had a confirmed diagnosis for more than 10 years - If you are a healthy control: you do not have diabetes or pre-diabetes **You may NOT be eligible if...** - You have another reason for nerve damage (e.g., vitamin B12 deficiency, excessive alcohol use, or prior chemotherapy) - You have been immobile for more than 3 months in the past, or more than 4 weeks in the past 6 months - You have serious heart, lung, or other chronic organ disease - You have inflammatory joint or bowel disease, or a chronic muscle disease - You have an active cancer, eating disorder, or history of weight-loss surgery - You take anticoagulants, steroids, or hormonal therapies that affect bone/muscle - Your diabetes is poorly controlled (HbA1c above 9%) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DIAGNOSTIC_TESTBlood sampling

Fasting blood samples will be obtained.

DIAGNOSTIC_TESTElectromyoneurography (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.

PROCEDUREMuscle biopsy

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

RADIATIONQuantitative peripheral computed tomography (qPCT)

A qPCT scan of the calf will be performed.

DEVICEMechanography

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

DIAGNOSTIC_TESTElectrocardiography (ECG)

A 15-minute resting ECG will be performed.

OTHERQuestionnaires

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).

OTHERAnthropometry

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.