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OpenTrials
Completed

NCT Number: NCT04758364

Factors That Effect the Gait Speed in Diabetic Individuals Without Neuropathy

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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,
  • cancer,
  • chemo/radiotherapy,
  • foot ulcer,
  • orthopedical or surgical problems
  • wheel-chair or any assistive devices for ambulation
  • prominent knee or hip arthritis, prosthesis

Treatment and study plan

measurement of gait speed

Other

Cross sectional, cohort

Other names: measurement of aerobic capacity, measurement of muscle mass, measurement of blood glucose and HbA1c, cognitive function testing, physical activity questioning, blood pressure measurement

Primary outcomes

  1. gait speed

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

    gait speed measured by wearable accelerometer

Sponsors and collaborators

Lead sponsor

GULIN FINDIKOGLU

Other

Registry information

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Feb 17, 2021
Registry last updated
Apr 1, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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