NCT06519942

Muscle and Bone in Patients with Diabetes Mellitus and Neuropathy

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 145 (estimated)
• Sponsor: University Hospital, Ghent · Academic / Other
• Sex: All
• Age: 40 Years – 70 Years
• Healthy volunteers: Accepted

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

Conditions

• Diabetes Mellitus, Type 2
• Diabetic Peripheral Neuropathy
• Sarcopenia

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2023-12-12
• Primary completion: 2025-11-01
• Completion: 2025-11-01
• First posted: 2024-07-25
• Last updated: 2024-09-19

Locations

1 site across 1 country: Belgium