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临床试验/NCT04779164
NCT04779164已完成不适用

The Relation Between Abdominal Obesity, Type 2 Diabetes Mellitus and Knee Osteoarthritis

Eskisehir City Hospital1 个研究点 分布在 1 个国家目标入组 126 人开始时间: 2020年9月4日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
126
试验地点
1
主要终点
Femoral cartilage thickness

研究概览

简要总结

Background:Knee osteoarthritis is more common in patients with type-2 diabetes mellitus, however it is not known whether this effect is caused by diabetes itself or concominant abdominal obesity.

Objectives:The aim of this study is to determine whether type-2 diabetes itself, independent of abdominal obesity, is a risk factor for femoral cartilage, knee osteoarthritis and poor quality of life.

Design:A cross-sectional design. Settings:Training and research hospital in Turkey. Patients and Methods:Female patients was enrolled in this study and divided into two groups: according to presence or absence of diabetes. Later, both the patients with and without abdominal obesity was divided into two groups according the presence of diabetes.

Main Outcome measures:Clinical parameters were visual analog-scale, gait speed and short form-36. Knee radiographs were evaluated according to Kellgren Lawrance-Scale. And ultrasonography parameters were the measurements of distal femoral cartilage thickness.

Sample size:126

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Screening
盲法
None

入排标准

年龄范围
40 Years 至 70 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • being female
  • aged between 40 and 70.

排除标准

  • Patients with any concomitant chronic disease
  • rheumatoid arthritis
  • cardiac diseases (except type 2 diabetes mellitus and hypertension)
  • knee surgery
  • bone mass or cancer
  • inflammatory arthritis
  • impaired cognitive status
  • immobilized patients
  • type 1 diabetes mellitus

结局指标

主要结局

Femoral cartilage thickness

时间窗: baseline

Measured by ultrasonography (higher value:thick cartilage, lower value:thin cartilage)

次要结局

  • visual analog scale(baseline)
  • radiographic knee osteoarthritis(baseline)

研究者

发起方
Eskisehir City Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Fulya Bakılan

principal investigator

Eskisehir City Hospital

研究点 (1)

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