The Relation Between Diabetic Neuropathy and Muscle Mass in Type 2 Diabetes Mellitus Patients

Recruiting

• Conditions: Diabetic Neuropathy; Sarcopenia

• Registration Number: NCT06958302
• Lead Sponsor: Ain Shams University

Brief Summary

The goal of this observational study is to evaluate the relation between diabetic neuropathy in type 2 diabetes mellitus patients and muscle mass

Detailed Description

The goal of this observational study is to evaluate the relation between diabetic neuropathy in type 2 diabetes mellitus patients, aged above 45 years old, and muscle mass; where it uses ultrasound to measure anterior thigh muscle thickness and adjusts it to body mass index to calculate muscle mass and the participants perform clinical tests i.e hand grip strength test and chair stand test in order to assess muscle power. Depending on both muscle mass and muscle power/function, Sarcopenia could be assessed in this group of patients, and its relation to diabetic neuropathy, tested by nerve conduction studies, would be researched.

Study Timeline

• Status Verified: 2025-03
• Study First Submitted: 2025-04-06
• Study First Submitted QC: 2025-04-26
• Last Update Submitted: 2025-04-26
• Study First Posted: 2025-05-06
• Last Update Posted: 2025-05-06
• Study Start: 2025-05-30
• Primary Completion: 2025-11-10
• Study Completion: 2026-06-15

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Relation between diabetic neuropathy and muscle mass	Day 1 Neurological examination and clinical physical performance tests for sarcopenia, 2 weeks later: nerve conduction studies for both lower limbs, the 3rd week: ultrasound assessment for thigh muscle thickness	Relation between Diabetic neuropathy severity (mild/moderate/severe) using nerve conduction studies classification criteria (Baba's classification) and skeletal muscle mass as indicated by a ratio (anterior thigh muscle thickness measured by ultrasound/ BMI) (millimeteres for muscle thickness ) and (kg/m\^2 for the BMI)

Trial Locations

Locations (1)

Ain Shams university; 🇪🇬 Cairo, Abbassia, Egypt