Factors That Effect the Gait Speed in Diabetic Individuals Without Neuropathy

NCT ID: NCT04758364

Last Updated: 2021-04-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

71 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-02-20

Study Completion Date

2021-03-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Gait Disorder, Sensorimotor Diabetes Mellitus, Type 2

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

measurement of gait speed

Cross sectional, cohort

Intervention Type OTHER

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

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

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

GULIN FINDIKOGLU

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

GULIN FINDIKOGLU

Assoc Proffessor, MD, PhD

Responsibility Role SPONSOR_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Pamukkale University

Denizli, , Turkey (Türkiye)

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Turkey (Türkiye)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

60116787-020/75097

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Gait and Balance of Diabetes Type 2 Patients
NCT00637546 COMPLETED PHASE2/PHASE3