Muscle and Bone in Patients with Diabetes Mellitus and Neuropathy

Launched by UNIVERSITY HOSPITAL, GHENT · Jul 19, 2024

Keywords

ClinConnect Summary

This clinical trial is studying how muscle fibers are affected in people with type 2 diabetes who have a common nerve-related complication called diabetic peripheral neuropathy (DNP). The researchers want to find out if there are differences in muscle fiber types between those with DNP, those without it, and healthy individuals of similar age and sex. To do this, they will conduct several tests, such as checking nerve function, analyzing blood samples, taking muscle biopsies, and conducting physical tests to assess muscle strength. Participants will also fill out questionnaires about their lifestyle and health.

To be eligible for this study, participants should be between 40 and 70 years old with a body mass index (BMI) between 18.5 and 35. Those with type 2 diabetes should have had their diagnosis for more than 10 years. The study excludes people with certain health conditions that could affect nerve function, such as vitamin deficiencies or chronic diseases. If you join the study, you will undergo various tests and evaluations to help researchers better understand how diabetes and its complications impact muscle health.

Gender

ALL

Eligibility criteria

• 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 %