Actively Recruiting
Muscle and Bone in Patients with Diabetes Mellitus and Neuropathy
Led by University Hospital, Ghent · Updated on 2024-09-19
145
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
U
University Hospital, Ghent
Lead Sponsor
U
University Ghent
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are investigating muscle fiber type differences in people with type 2 diabetes mellitus (T2DM), focusing on those with diabetic peripheral neuropathy (DNP), a common complication. The study compares muscle and nerve function, inflammation, cellular energy use, and blood vessel health among three groups: T2DM patients with DNP, T2DM patients without DNP, and healthy individuals matched by age and sex. The main question is whether muscle fiber types vary among these groups. Participants will undergo several evaluations including electromyoneurography (EMNG) to assess nerve function, blood tests to measure insulin, blood sugar, lipids, and inflammation, and muscle biopsies of the calf muscle to examine muscle structure. Additional tests include functional muscle strength and power assessments through jumping and chair rise tests (mechanography), a calf scan using peripheral Quantitative Computed Tomography (pQCT) for muscle and bone density, and a 15-minute resting electrocardiogram (ECG). Questionnaires will gather information on diet, physical activity, smoking, alcohol use, and medical history. During the study, participants will have their height, weight, and hip-to-waist ratio measured. Researchers will analyze differences in muscle fiber composition, nerve conduction velocity, muscle and bone density, mitochondrial function, physical activity levels, and lifestyle factors at enrollment. The study is observational and involves no treatment. The total participation time varies but includes all listed assessments at enrollment. The research is led by University Hospital, Ghent.
CONDITIONS
Brief Title
Muscle and Bone in Patients with Diabetes Mellitus and Neuropathy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Between 40 and 70 years of age
- Body mass index (BMI) between 18.5 and 35 kg/m2
- For persons with type 2 diabetes: clinical diagnosis of type 2 diabetes mellitus for more than 10 years
You will not qualify if you...
- Possible other causes of nerve impairment such as vitamin B12 deficiency, excessive alcohol consumption, or chemotherapy
- Immobilization for more than 3 months in past history or more than 4 weeks in the past 6 months
- Chronic conditions affecting vital organs (New York Heart Association 3/4, Global Initiative for Obstructive Lung Disease 3/4, cystic fibrosis)
- Hypogonadism
- Inflammatory joint or intestinal diseases
- Chronic muscle diseases
- Active malignancy
- Malnutrition, eating disorder, or history of bariatric surgery
- Use of medications such as anticoagulants, glucocorticoids, anti-androgen, or anti-estrogen treatments
- For persons with type 2 diabetes: insufficient diabetes control (HbA1c >9%)
- For healthy controls: fasting glucose >100 mg/dl or HbA1c >5.7 %
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - At enrollment
Participants undergo diagnostic tests including blood sampling, electromyoneurography (EMNG), electrocardiography (ECG), quantitative peripheral computed tomography (qPCT) scan of the calf, muscle biopsy, mechanography tests, questionnaires regarding medical background and lifestyle, and anthropometry measurements.
1 visit (in-person)
Duration - Up to study completion in November 2025
Participants are observed over time to assess differences in muscle and bone characteristics, nerve conduction, physical activity, lifestyle factors, and other health measures related to diabetes and neuropathy.
Follow-up assessments as scheduled by the study
Trial Site Locations
Total: 1 location
1
Ghent University Hospital
Ghent, Belgium, 9000
Actively Recruiting
Research Team
C
Cato Van De Looverbosch
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
3
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