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
98 weeks
Total Duration
On this page
Sponsors
U
University Hospital, Ghent
Lead Sponsor
U
University Ghent
Collaborating Sponsor
AI-Summary
What this Trial Is 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
CONDITIONS
Official 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 mellitus: clinical diagnosis for more than 10 years
You will not qualify if you...
- Possible other causes of nerve damage such as vitamin B12 deficiency, excessive alcohol use, or chemotherapy
- Immobilization longer than 3 months in past history or longer than 4 weeks in past 6 months
- Chronic serious conditions affecting vital organs (New York Heart Association class 3 or 4 heart disease, Global Initiative for Obstructive Lung Disease class 3 or 4, cystic fibrosis)
- Hypogonadism
- Inflammatory joint or intestinal diseases
- Chronic muscle diseases
- Active cancer
- Malnutrition, eating disorders, or history of bariatric surgery
- Use of anticoagulants, glucocorticoids, anti-androgen, or anti-estrogen medications
- For persons with type 2 diabetes: poor diabetes control with HbA1c greater than 9%
- For healthy controls: fasting glucose above 100 mg/dl or HbA1c above 5.7%
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Ghent University Hospital
Ghent, Belgium, 9000
Actively Recruiting
Research Team
C
Cato Van De Looverbosch
CONTACT
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
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here