NCT04758364

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
71

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Feb 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 11, 2021

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 17, 2021

Completed
3 days until next milestone

Study Start

First participant enrolled

February 20, 2021

Completed
20 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 12, 2021

Completed
18 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2021

Completed
Last Updated

April 1, 2021

Status Verified

March 1, 2021

Enrollment Period

20 days

First QC Date

February 11, 2021

Last Update Submit

March 30, 2021

Conditions

Keywords

Mini-Mental State Examinationgaitaerobic capacityHbA1cmusclehypertensionglucose

Outcome Measures

Primary Outcomes (1)

  • gait speed

    gait speed measured by wearable accelerometer

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

Interventions

Cross sectional, cohort

Also known as: 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

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Type 2 Diabetic individuals without neuropathy

You may qualify if:

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

You may not qualify if:

  • 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
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pamukkale University

Denizli, 21600, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Gait Disorders, NeurologicDiabetes Mellitus, Type 2Hypertension

Condition Hierarchy (Ancestors)

Neurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsDiabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesVascular DiseasesCardiovascular Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
1 Month
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Assoc Proffessor, MD, PhD

Study Record Dates

First Submitted

February 11, 2021

First Posted

February 17, 2021

Study Start

February 20, 2021

Primary Completion

March 12, 2021

Study Completion

March 30, 2021

Last Updated

April 1, 2021

Record last verified: 2021-03

Data Sharing

IPD Sharing
Will not share

Locations