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NCT04758364 Clinical Trial

Factors That Effect the Gait Speed in Diabetic Individuals Without Neuropathy

Diabetes Mellitus, Type 2 Clinical Trial

Official title:
Factors That Effect the Gait Speed in Diabetic Individuals Without Neuropathy

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04758364
Other study ID # 60116787-020/75097
Secondary ID
Status Completed
Phase
First received
Last updated
Start date February 20, 2021
Est. completion date March 30, 2021

Study information
Verified date March 2021
Source Pamukkale University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility
Status Completed
Enrollment 71
Est. completion date March 30, 2021
Est. primary completion date March 12, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• measurement of gait speed
Cross sectional, cohort

Locations
Country Name City State
Turkey Pamukkale University Denizli

Sponsors (1)
Lead Sponsor Collaborator
GULIN FINDIKOGLU

Country where clinical trial is conducted

Turkey, 

Outcome
Type Measure Description Time frame Safety issue
Primary gait speed gait speed measured by wearable accelerometer The gait speed will be measured once within a month after the participants enrolled.
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