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临床试验/NCT06958302
NCT06958302招募中不适用

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

Ain Shams University1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2025年5月30日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
60
试验地点
1
主要终点
Relation between diabetic neuropathy and muscle mass

研究概览

简要总结

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

详细描述

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.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Cross Sectional

入排标准

年龄范围
45 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • The study group consisted of patients diagnosed with Type 2 diabetes mellitus aged ≥45 years old

排除标准

  • 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

结局指标

主要结局

Relation between diabetic neuropathy and muscle mass

时间窗: 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)

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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