Clinical trial NCT06958302: The Relation Between Diabetic Neuropathy and Muscle Mass in Type 2 Diabetes Mellitus Patients
Official title: The Relation Between Diabetic Neuropathy and Muscle Mass in Type 2 Diabetes Mellitus Patients
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Diabetic Neuropathy
Sarcopenia
Keywords: diabetic neuropathy
muscle mass
sarcopenia
nerve conduction studies
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2025-05-06
Enrollment: 60
Sex: ALL
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study group consisted of patients diagnosed with Type 2 diabetes mellitus aged ≥45 years old

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.

Eligibility 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

Primary outcomes:
measure: Relation between diabetic neuropathy and muscle mass
timeFrame: 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
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ain Shams university
state: Abbassia
city: Cairo
country: Egypt
facility: Ain Shams university
state: Abbassia
Study officials:
affiliation: Ain Shams University
name: Rana A Al Hilaly, MD
role: STUDY_DIRECTOR
References:
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