Muscle and Bone in Patients with Diabetes Mellitus and Neuropathy

ConditionsDiabetes Mellitus, Type 2 Diabetic Peripheral Neuropathy Sarcopenia

Trial statusRecruiting

Trial phaseNot listed

Trial typeObservational

Biological sexAll

Age40-70

SponsorUniversity Hospital, Ghent

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

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Between 40-70 years of age

BMI between 18,5 - 35 kg/m2

More than 10-year clinical diagnosis of T2DM

Disqualifiers

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

Trial population

Participants will be recruited through the Ghent University Hospital, diabetes educators and podologists.

Trial design

Design model

Case-control

Time perspective

Cross-sectional

Treatments tested in this trial

Blood sampling
Diagnostic test
Fasting blood samples will be obtained.
Electromyoneurography (EMNG)
Diagnostic test
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.
Muscle biopsy
Procedure/Surgery
Muscle biopsy of the m. gastrocnemius will be performed under local anesthesia using the modified Bergström technique.
Quantitative peripheral computed tomography (qPCT)
Radiation
A qPCT scan of the calf will be performed.
Mechanography
Device
Single two leg jump, multiple one leg hopping, chair rise and sit to stand tests will be performed.
Electrocardiography (ECG)
Diagnostic test
A 15-minute resting ECG will be performed.
Questionnaires
Other intervention
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).
Anthropometry
Other intervention
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.

Treatment groups

145 Participants

are divided into 3 treatment groups

Group A: T2DM DNP+8 interventions

Group B: T2DM DNP-8 interventions

Group C: HC8 interventions

Trial outcomes

Primary outcomes

Differences in muscle fiber type composition in persons with type 2 diabetes with diabetic peripheral neuropathy compared to persons with type 2 diabetes without diabetic neuropathy and healthy controls.

Differences in muscle fiber type distribution, percentage and cross-sectional area will be evaluated through myosin heavy chain (MHC) immunostaining of the muscle specimen.

Time frame

At enrollment

Secondary outcomes

Differences in nerve conduction velocity in persons with type 2 diabetes with diabetic peripheral neuropathy compared to persons with type 2 diabetes without diabetic neuropathy and healthy controls

Nerve conduction velocity will be examined through EMNG examination to examine neuromotor function

Time frame

At enrollment

Differences in capillarization in persons with type 2 diabetes with diabetic peripheral neuropathy compared to persons with type 2 diabetes without diabetic neuropathy and healthy controls.

Capillarization will be examined through histological examination of the muscle specimen using Ulex europaeus I (UEA-I) staining.

Time frame

At enrollment

Differences in electron microscopic properties assessing mitochondrial function in persons with type 2 diabetes with diabetic peripheral neuropathy compared to persons with type 2 diabetes without diabetic neuropathy and healthy controls

Mitochondrial function will be examined through electron microscopy of the muscle specimen.

Time frame

At enrollment

Differences in maximal force in persons with type 2 diabetes with diabetic peripheral neuropathy compared to persons with type 2 diabetes without diabetic neuropathy and healthy controls.

Maximal force will be evaluated using mechanography through multiple one leg hopping.

Time frame

At enrollment

Other outcomes

Differences in heart rate variability in persons with type 2 diabetes with diabetic peripheral neuropathy compared to persons with type 2 diabetes without diabetic neuropathy and healthy controls.

Heart rate variability will be examined through a 15-minute resting ECG.

Time frame

At enrollment

Differences in interleukin 6 (IL-6) concentration in persons with type 2 diabetes with diabetic peripheral neuropathy compared to persons with type 2 diabetes without diabetic neuropathy and healthy controls.

Differences in inflammation will be evaluated through blood analysis of IL-6.

Time frame

At enrollment

Differences in tumor necrosis factor alpha (TNFα) concentration in persons with type 2 diabetes with diabetic peripheral neuropathy compared to persons with type 2 diabetes without diabetic neuropathy and healthy controls.

Differences in inflammation will be evaluated through blood analysis of TNFα.

Time frame

At enrollment

Differences in C-reactive protein (CRP) concentration in persons with type 2 diabetes with diabetic peripheral neuropathy compared to persons with type 2 diabetes without diabetic neuropathy and healthy controls.

Differences in inflammation will be evaluated through blood analysis of CRP.

Time frame

At enrollment

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University Hospital, Ghent

Lead sponsor

University Ghent

Collaborator

Source ClinicalTrials.gov

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