Status:
RECRUITING
Muscle and Bone in Patients with Diabetes Mellitus and Neuropathy
Lead Sponsor:
University Hospital, Ghent
Collaborating Sponsors:
University Ghent
Conditions:
Diabetes Mellitus, Type 2
Diabetic Peripheral Neuropathy
Eligibility:
All Genders
40-70 years
Brief Summary
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...
Eligibility Criteria
Inclusion
- 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
- 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 %
Key Trial Info
Start Date :
December 12 2023
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
November 1 2025
Estimated Enrollment :
145 Patients enrolled
Trial Details
Trial ID
NCT06519942
Start Date
December 12 2023
End Date
November 1 2025
Last Update
September 19 2024
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Ghent University Hospital
Ghent, Belgium, 9000