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临床试验/NCT04758364
NCT04758364已完成不适用

Factors That Effect the Gait Speed in Diabetic Individuals Without Neuropathy

GULIN FINDIKOGLU1 个研究点 分布在 1 个国家目标入组 71 人开始时间: 2021年2月20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
71
试验地点
1
主要终点
gait speed

研究概览

简要总结

This study planned to investigate the role of potential explanatory factors effecting the speed of gait such as muscle mass, aerobic capacity, physical activity status, cognitive function, blood pressure, and metabolic measures considering age, sex, and education years in diabetic individuals without neuropathy.

详细描述

Type 2 diabetic people will be screened by clinical symptoms of neuropathy and DN4 questionnaire. Among those who did not have neuropathic symptoms or who have DN4 score below 4 will be considered for the study.Then aerobic capacity will be measured by a cycle ergometer and VO2max will be obtained. Weight, body mass index and muscle mass will be measured by bioimpedance analysis. Physical activity status will be determined by International Physical Activity Score (IPAQ). Cognitive function will be evaluated by Mini Mental test. HbA1c and fasting blood glucose will be measured in venous blood after overnight fasting. Blood pressure will be measured in the sitting position after resting from the left arm. Speed of gait will be measured by an accelerometer.Then, the effect of above mentioned factors on speed of gait will be studied.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Individuals with Diabetes Mellitus less than 10 years but longer than 1 year
  • Absence of neuropathic symptoms
  • DN4 questionnaire sore less than 4

排除标准

  • Individuals who had
  • insulin therapy,
  • poor glycemic control,
  • manifesting cardiovascular disease,
  • retinopathy or other visual problems,
  • diabetic neuropathy,
  • nephropathy,
  • cerebrovascular disease,
  • cognitive impairment,
  • heart failure,
  • alcohol or cigarette dependence,
  • chemo/radiotherapy,
  • foot ulcer,
  • orthopedical or surgical problems
  • wheel-chair or any assistive devices for ambulation
  • prominent knee or hip arthritis, prosthesis

结局指标

主要结局

gait speed

时间窗: The gait speed will be measured once within a month after the participants enrolled.

gait speed measured by wearable accelerometer

次要结局

未报告次要终点

研究者

发起方
GULIN FINDIKOGLU
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

GULIN FINDIKOGLU

Assoc Proffessor, MD, PhD

Pamukkale University

研究点 (1)

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