The Relation Between Diabetic Neuropathy and Muscle Mass in Type 2 Diabetes Mellitus Patients
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age45+
SponsorAin Shams University
About this trial
The goal of this observational study is to evaluate the relation between diabetic neuropathy in type 2 diabetes mellitus patients and muscle mass
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
The study group consisted of patients diagnosed with Type 2 diabetes mellitus aged ≥45 years old
Disqualifiers
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
Trial population
The study group consisted of patients diagnosed with Type 2 diabetes mellitus aged ≥45 years old
Trial design
Design model
Case-only
Time perspective
Cross-sectional
Treatments tested in this trial
Not listed
Trial groups
60 Participants
are grouped into 1 trial groupGroup A: type 2 diabetic patients
Trial outcomes
Primary outcomes
1
Relation between diabetic neuropathy and muscle mass
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)
Time frame
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 thicknessSponsors and contacts
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Source ClinicalTrials.gov