Evaluating muscle and bone health in people with diabetes and neuropathy
Muscle and Bone in Patients with Diabetes Mellitus and Neuropathy
This study is trying to see how muscle health is affected in people with type 2 diabetes and nerve damage compared to healthy individuals.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 145 (estimated) |
| Ages | 40 Years to 70 Years |
| Sex | All |
| Sponsor | University Hospital, Ghent Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Ghent) |
| Trial ID | NCT06519942 on ClinicalTrials.gov |
What this trial studies
This observational study aims to assess the composition of muscle fiber types in individuals with type 2 diabetes mellitus (T2DM) who also experience diabetic peripheral neuropathy (DNP). Researchers will compare these individuals to age and sex-matched healthy peers to identify differences in muscle fiber composition. The study will involve various tests, including electromyoneurography to evaluate nerve function, blood analysis for metabolic factors, and muscle biopsies to analyze muscle tissue. The goal is to understand the relationship between muscle health and diabetic complications.
Who should consider this trial
Good fit: Ideal candidates include individuals aged 40-70 with a clinical diagnosis of type 2 diabetes for over 10 years.
Not a fit: Patients with other causes of nerve impairment or chronic conditions affecting vital organs may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved understanding and management of muscle and nerve health in patients with diabetes.
How similar studies have performed: While similar studies have explored muscle and nerve health in diabetes, this specific focus on muscle fiber composition in relation to DNP is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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 %
Where this trial is running
Ghent
- Ghent University Hospital — Ghent, Belgium (Recruiting)
Study contacts
- Principal investigator: Bruno Lapauw — University Hospital, Ghent
- Study coordinator: Cato Van De Looverbosch
- Email: cato.vandelooverbosch@ugent.be
- Phone: 0479922969
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.