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

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06958302
Enrollment
60
Registered
2025-05-06
Start date
2025-05-30
Completion date
2026-06-15
Last updated
2025-05-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetic Neuropathy, Sarcopenia

Keywords

diabetic neuropathy, muscle mass, sarcopenia, nerve conduction studies

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.

Interventions

None listed

Sponsors

Ain Shams University
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
45 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Relation between diabetic neuropathy and muscle massDay 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 thicknessRelation 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)

Countries

Egypt

Contacts

Primary ContactWafaa M Mohamed Abd ElAzim, Masters degree
wafaa.mahmoud@med.asu.edu.eg+201012932752

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026