NCT06190938

Brief Summary

Observation study, shows the relation between diabetes, its neurological and optical complication and hearing loss, by asking participants questions about there age,BMI,job,the history of any cataract,diabetes retinopathy or heart attack,hypertension,swollen or tingling legs and take there consent to measure the hearing impairment.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
87

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2022

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

June 23, 2022

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 12, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 22, 2022

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

October 20, 2023

Completed
3 months until next milestone

First Posted

Study publicly available on registry

January 5, 2024

Completed
Last Updated

January 5, 2024

Status Verified

December 1, 2023

Enrollment Period

5 months

First QC Date

October 20, 2023

Last Update Submit

December 19, 2023

Conditions

Keywords

Diabetes retinopathyCataract

Outcome Measures

Primary Outcomes (1)

  • The Demographic characteristics were classified into four groups: Gender, Financial status, Educational level, and Profession.

    Gender was either male or female. Income was divided into three categories: Low Income (those who were unable to provide even the basics for themselves), Fair Income (basics and some additional expenses), and High Income. Professions were divided into four types: Retired, Housewife, Worker and Student. Educational degree was categorized as Lower than High School, High School, or Higher than High School. Hypertension was measured and considered higher than normal when exceeded 140/90 mmHg. Both height and weight were measured to calculate the BMI of each subject. Weight was measured in kilograms. Height was measured in meters. BMI that scored less than 25, between 25-30, 30 or more was considered, underweight normal, and obese respectively. "The number of patients diagnosed with diabetes who showed signs of hearing impairment at certain stages of their lives, and how this related to other neurological signs, is being investigated.

    The study took 6 months to finish it with hard work, it was hard to reach our participants so it tooks 2 weeks from us for each participant to finish our survey

Study Arms (1)

The relation between diabetes, its neurological and optical complications with hearing loss

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

We collected participants from the clinical of Damascus hospital

You may qualify if:

  • Diabetics who signed consent for the study.
  • Diabetics who have filled out the form completely.
  • Diabetics who have undergone a pure tone hearing screening test .

You may not qualify if:

  • Patients with glandular disease causing hearing loss.
  • Patients with traumatic ear injury.
  • Patients who have recently had a middle or inner ear infection.
  • History of acoustic neuroma.
  • Patients are under active treatment with medications that have a toxic effect on the auditory cells.
  • Patients with diabetic foot.
  • The patient's occupation or residence is within a noisy environment.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mohamad Zaid Ahmad Abdalla

Damascus, Syria

Location

MeSH Terms

Conditions

Diabetes MellitusDiabetes ComplicationsHearing LossCataract

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesHearing DisordersEar DiseasesOtorhinolaryngologic DiseasesSensation DisordersNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsLens DiseasesEye Diseases

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Target Duration
2 Weeks
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr in Damascus university in general internal medicine

Study Record Dates

First Submitted

October 20, 2023

First Posted

January 5, 2024

Study Start

June 23, 2022

Primary Completion

November 12, 2022

Study Completion

December 22, 2022

Last Updated

January 5, 2024

Record last verified: 2023-12

Data Sharing

IPD Sharing
Will not share

Locations