Muscle and Bone in Patients with Diabetes Mellitus and Neuropathy

RecruitingOBSERVATIONAL
Enrollment

145

Participants

Timeline

Start Date

December 12, 2023

Primary Completion Date

November 30, 2025

Study Completion Date

November 30, 2025

Conditions
Diabetes Mellitus, Type 2Diabetic Peripheral NeuropathySarcopenia
Interventions
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.

Trial Locations (1)

9000

RECRUITING

Ghent University Hospital, Ghent

All Listed Sponsors
collaborator

University Ghent

OTHER

lead

University Hospital, Ghent

OTHER