NCT05725889

Brief Summary

Background: The primary purpose of our study was to understand the damage in the peripheral nerves of patients with diabetes and to determine the change in patients' reaction rates and perceptions by the age groups, duration of diabetes, fasting plasma glucose and HbA1c values, and compare these with those of the healthy individuals. Methods: This study was carried out at the Baskent University Hospital Endocrinology and Metabolic Diseases Outpatient Clinic. A total of 64 patients diagnosed with type 2 diabetes and 64 healthy controls were included in the study. Finger tapping, visual, and auditory reaction time tests were performed on the subjects, respectively. The subjects' fasting plasma glucose and HbA1c levels, and the duration of their diabetes were recorded. Analyses were performed using the SPSS version 25. Differences were considered statistically significant when the p-value is \<0.05.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
128

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 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

Study Start

First participant enrolled

July 15, 2021

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 15, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 14, 2021

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

November 29, 2022

Completed
3 months until next milestone

First Posted

Study publicly available on registry

February 13, 2023

Completed
Last Updated

February 13, 2023

Status Verified

February 1, 2023

Enrollment Period

1 month

First QC Date

November 29, 2022

Last Update Submit

February 10, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • Finger tap, visual and auditory reaction test data within 10 seconds

    Reaction times

    April-September 2021

Study Arms (2)

DIABETES

Visual, finger tapping and auditory tests were performed regularly. The subjects' fasting plasma glucose and HbA1c levels, and the duration of their diabetes were recorded.

Device: recation time test

CONTROL

Visual, finger tapping and auditory tests were performed regularly. The subjects' fasting plasma glucose and HbA1c levels were recorded.

Device: recation time test

Interventions

visual-finger tapping and auditory reaction time tests

CONTROLDIABETES

Eligibility Criteria

Age18 Years - 65 Years
Sexall(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

The study population consisted of healthy individuals aged between 18-64 years, diagnosed with type 2 diabetes, and resided in Ankara. The sample comprised 128 volunteers, 64 of whom were patients and 64 were controls.

You may qualify if:

  • Right-handed individuals
  • Must be between 18-65 ages
  • Must be Type 2 diabetics at least 6 months (for patient group)

You may not qualify if:

  • use of alcohol-drug or similar substances,
  • the use of any medication that may affect neurological functions,
  • having color blindness,
  • retinopathy,
  • neurological disease,
  • cancer,
  • depression,
  • a recent history of surgery,
  • rheumatoid arthritis,
  • osteoarthritis,
  • and advanced osteoarthritis.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Baskent University

Ankara, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesCognition DisordersNeurocognitive DisordersMental Disorders

Study Officials

  • melisa bilaloğlu, res asst

    Baskent University

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
RESEARCH ASSISTANT

Study Record Dates

First Submitted

November 29, 2022

First Posted

February 13, 2023

Study Start

July 15, 2021

Primary Completion

August 15, 2021

Study Completion

September 14, 2021

Last Updated

February 13, 2023

Record last verified: 2023-02

Locations