Muscle and Bone in Patients with Diabetes Mellitus and Neuropathy (SVT-DNP)

Ghent University Hospital (UZ)

Status: Enrolling

Conditions: Diabetes Mellitus, Type 2; Sarcopenia; Diabetic Peripheral Neuropathy

Treatments: Other: Anthropometry; Other: Questionnaires; Diagnostic Test: Electrocardiography (ECG); Diagnostic Test: Electromyoneurography (EMNG); Radiation: Quantitative peripheral computed tomography (qPCT); Device: Mechanography; Procedure: Muscle biopsy; Diagnostic Test: Blood sampling

Study type: Observational

Funder types: Other

Identifiers

NCT06519942

BOF.24Y.2023.0030.01 (Other Grant/Funding Number)

ONZ-2023-0120

Details and patient eligibility

About

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

Enrollment: 145 estimated patients

Sex: All

Ages: 40 to 70 years old

Volunteers: Accepts Healthy Volunteers

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 %

Trial design

145 participants in 3 patient groups

T2DM DNP+

Description:

type 2 diabetes with diabetic neuropathy

Treatment:

Diagnostic Test: Blood sampling

Device: Mechanography

Procedure: Muscle biopsy

Other: Questionnaires

Diagnostic Test: Electrocardiography (ECG)

Radiation: Quantitative peripheral computed tomography (qPCT)

Diagnostic Test: Electromyoneurography (EMNG)

Other: Anthropometry

T2DM DNP-

Description:

type 2 diabetes without diabetic neuropathy

Treatment:

Diagnostic Test: Blood sampling

Device: Mechanography

Procedure: Muscle biopsy

Other: Questionnaires

Diagnostic Test: Electrocardiography (ECG)

Radiation: Quantitative peripheral computed tomography (qPCT)

Diagnostic Test: Electromyoneurography (EMNG)

Other: Anthropometry

HC

Description:

healthy controls

Treatment:

Diagnostic Test: Blood sampling

Device: Mechanography

Procedure: Muscle biopsy

Other: Questionnaires

Diagnostic Test: Electrocardiography (ECG)

Radiation: Quantitative peripheral computed tomography (qPCT)

Diagnostic Test: Electromyoneurography (EMNG)

Other: Anthropometry