Diabetes MellitusNCT06190938
Diabetes Complications and Hearing Loss
An observational study of Diabetes Mellitus and Diabetes Complications, run by Syrian Private University at 1 site in Syria.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Diabetes Mellitus, Diabetes Complications, Hearing Loss
- How many people
- 87 participants
- Where
- 1 siteSyria
- Study dates
- 23 Jun 2022to 22 Dec 2022
- How long will I take part?
- 2 Weeks
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: We collected participants from the clinical of Damascus hospital
Who may be able to join
- 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 .
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Relationship Between Diabetes, Its Neurological and Optical Complications, and Hearing Loss.
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.
- Conditions
- Diabetes Mellitus, Diabetes Complications, Hearing Loss
- Keywords
- Diabetes retinopathy, Cataract
- Medical subject headings
- Diabetes Mellitus, Diabetes Complications, Hearing Loss, Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| The relation between diabetes, its neurological and optical complications with hearing loss | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2024
- Study start23 Jun 2022
- Primary completion12 Nov 2022
- Study completion22 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes MellitusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 87 participants (actual)
- Target duration
- 2 Weeks
Sponsor and investigators
- Lead sponsor
- Syrian Private University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamad Zaid Mohamad Samer Ahmad Abdalla, Syrian Private University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06190938
- Sponsor's protocol ID
- Observation
- Status last verified
- Dec 2023
- First submitted
- 20 Oct 2023
- Last updated
- 5 Jan 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Relationship Between Diabetes, Its Neurological and Optical Complications, and Hearing Loss.
- ClinicalTrials.gov ID
- NCT06190938
- Acronym / sponsor ID
- Observation
- Conditions
- Diabetes Mellitus, Diabetes Complications, Hearing Loss
- Keywords
- Diabetes retinopathy, Cataract
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 87 participants (actual)
- Lead sponsor
- Syrian Private UniversityUniversity, hospital or other
- Study start
- 23 Jun 2022 (actual)
- Primary completion
- 12 Nov 2022 (actual)
- Study completion
- 22 Dec 2022 (actual)
- First posted
- 5 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Target follow-up
- 2 Weeks
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| The relation between diabetes, its neurological and optical complications with hearing loss | – | – |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- We collected participants from the clinical of Damascus hospital
Key inclusion criteria (3 listed)
- 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 .
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The Demographic characteristics were classified into four groups: Gender, Financial status, Educational level, and Profession.
Time frame: 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
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes Mellitus and Diabetes Complications, run by Syrian Private University at 1 site in Syria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Syria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Demographic characteristics were classified into four groups: Gender, Financial status, Educational level, and Profession. (time frame: 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jan 2024.