Examining the link between diabetic neuropathy and muscle mass in type 2 diabetes patients
The Relation Between Diabetic Neuropathy and Muscle Mass in Type 2 Diabetes Mellitus Patients
This study looks at how diabetic nerve damage affects muscle mass and strength in people over 45 with type 2 diabetes.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 60 (estimated) |
| Ages | 45 Years and up |
| Sex | All |
| Sponsor | Ain Shams University Academic / other |
| Locations | 2 sites (Cairo, Abbassia and 1 other locations) |
| Trial ID | NCT06958302 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate the relationship between diabetic neuropathy and muscle mass in patients with type 2 diabetes mellitus aged over 45. It utilizes ultrasound to measure anterior thigh muscle thickness, adjusting for body mass index to calculate muscle mass. Participants will undergo clinical tests, including hand grip strength and chair stand tests, to assess muscle power and function. The study will also investigate the prevalence of sarcopenia in this population and its correlation with diabetic neuropathy, as determined by nerve conduction studies.
Who should consider this trial
Good fit: Ideal candidates for this study are patients diagnosed with type 2 diabetes mellitus who are aged 45 years or older.
Not a fit: Patients with type 1 diabetes, gestational diabetes, or those with severe comorbidities may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance understanding of the interplay between muscle mass and diabetic neuropathy, potentially leading to improved management strategies for patients with type 2 diabetes.
How similar studies have performed: While there have been studies examining aspects of diabetic neuropathy and muscle mass, this specific observational approach focusing on the relationship in type 2 diabetes patients is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * The study group consisted of patients diagnosed with Type 2 diabetes mellitus aged ≥45 years old Exclusion Criteria: * Type 1 DM, gestational diabetes mellitus * Severe cardiopulmonary disease, significant/previous neurological disorder (e.g., ischemic stroke, Parkinson disease) causing difficulty during daily activities (e.g., walking), visual deficit, and psychiatric problem * Other neuropathy-associated factors such as: alcohol, nutrition, poisoning and drug addiction * Patients with renal diseases, malignancy and autoimmune diseases * Patients on long term use of Steroids
Where this trial is running
Cairo, Abbassia and 1 other locations
- Ain Shams university — Cairo, Abbassia, Egypt (Recruiting)
- Ain Shams university — Cairo, Abbassia, Egypt (Recruiting)
Study contacts
- Study coordinator: Wafaa M Mohamed Abd ElAzim, Masters degree
- Email: wafaa.mahmoud@med.asu.edu.eg
- Phone: +201012932752
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.