ANZCTR - Registration

Please note the ANZCTR will be unattended from Friday 20 December 2024 for the holidays. The Registry will re-open on Tuesday 7 January 2025. Submissions and updates will not be processed during that time.

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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers

Trial registered on ANZCTR

Registration number

ACTRN12615000486527

Ethics application status

Approved

Date submitted

12/02/2015

Date registered

15/05/2015

Date last updated

15/05/2015

Type of registration

Retrospectively registered

Titles & IDs

Public title

Prospective Study of Hearing Loss and Type I Diabetes

Scientific title

Diabetes and Hearing Loss (DHL): A Prospective Study Evaluating the Correlation Between Hearing Loss and Type I Diabetes

Secondary ID [1]

Nil

Universal Trial Number (UTN)

Trial acronym

DHL

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Hearing Loss

Diabetes Mellitus

Condition category

Condition code

Metabolic and Endocrine

Diabetes

Ear

Other ear disorders

Intervention/exposure

Study type

Observational

Patient registry

False

Target follow-up duration

Target follow-up type

Description of intervention(s) / exposure

All participants will be tested for hearing loss during one of their routine diabetes clinic visits using the Welch Allyn AM282 Audiometer at frequencies 250 through 8000 Hz. The visit is expected to take about 30 minutes including the hearing test, blood draw and urine collection. This will be a one visit study.

Intervention code [1]

Not applicable

Comparator / control treatment

None

Control group

Uncontrolled

Outcomes

Primary outcome [1]

To evaluate the correlation between hearing loss and the development of micro and macro-vascular complications in type I DM. The patients' medical charts will be reviewed for any documented micro or macro-vascular complications. In addition, all participants will be screened for neuropathy using the Michigan Neuropathy Screening Instrument (MNSI).

Timepoint [1]

At baseline (one visit study)

Secondary outcome [1]

To evaluate the correlation between hearing loss and hemoglobin A1C in type I DM.

Timepoint [1]

At baseline (one visit study)

Secondary outcome [2]

To evaluate the correlation between hearing loss and duration of diabetes in type I DM.

Timepoint [2]

At baseline (one visit study)

Secondary outcome [3]

To evaluate the correlation between hearing loss and serum levels of sRAGE in type I DM.

Timepoint [3]

At baseline (one visit study)

Secondary outcome [4]

To evaluate the correlation between hearing loss and urinary levels of oxidative stress biomarkers such as isoprostanes.

Timepoint [4]

At baseline (one visit study)

Secondary outcome [5]

To evaluate the correlation between hearing loss and serum levels of select inflammatory, angiogenesis, and oxidative stress biomarkers and in type I DM. These biomarkers include CRP, VEGF, and isoprostanes.

Timepoint [5]

At baseline (one visit study)

Eligibility

Key inclusion criteria

Inclusion Criteria:
1) Adult (aged 20-60 years-old) at start of screening.
2) Type I DM.

Minimum age

20 Years

Maximum age

60 Years

Sex

Both males and females

Can healthy volunteers participate?

Key exclusion criteria

Exclusion Criteria:
1) History of otitis media.
2) History of Meniere's disease
3) Noise exposure (Occupational, recreational, or military)
4) Use of toxic drugs:
a) High dose aspirin (6-8 g/day)
b) Antibiotics (e.g. aminoglycoside, erythromycin, tetracycline)
c) Loop diuretic
d) Cisplatin
e) 5-Fluorouracil
f) Bleomycin
5) Cocaine abuse.
6) Congenital diseases associated with hearing impairment such as Arnold Chiari malformation.

Study design

Purpose

Duration

Selection

Timing

Statistical methods / analysis

Recruitment

Recruitment status

Recruiting

Date of first participant enrolment

Anticipated

16/03/2015

Actual

23/03/2015

Date of last participant enrolment

Anticipated

Actual

Date of last data collection

Anticipated

Actual

Sample size

Target

Accrual to date

Final

Recruitment outside Australia

Country [1]

United States of America

State/province [1]

Funding & Sponsors

Funding source category [1]

Self funded/Unfunded

Name [1]

Address [1]

Country [1]

Primary sponsor type

Individual

Name

Mohammed Al-Sofiani

Address

University at Buffalo- CHS
Sisters of Charity Hospital
2157 Main St. 2nd Floor
Buffalo NY 14214

Country

United States of America

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

University at Buffalo Institutional Review Board (UBIRB)

Ethics committee address [1]

Office of Research Compliance | Clinical and Translational Research Center Room 5018 875 Ellicott St. | Buffalo, NY 142303

Ethics committee country [1]

United States of America

Date submitted for ethics approval [1]

06/11/2014

Approval date [1]

13/11/2014

Ethics approval number [1]

Summary

Brief summary

About 26 million people in the U.S. have diabetes and it is estimated that one in three Americans will be diabetics by 2050. High blood glucose, over time, can damage the blood vessels and nerves in the heart, brain, kidneys, eyes, and limbs and result in heart attacks, strokes, kidney failure, vision loss, foot ulcers, amputations, etc. 

         The inner ear is one of the organs rich in blood vessels and nerves and can be logically affected by diabetes. However, compared to the other diabetes complications, we know very little about the link between hearing loss and diabetes. Nearly 34.5 million people in the U.S. have some type of hearing loss which is almost similar to the number of diabetics in the U.S. In fact, the National Institute of Health (NIH) found that hearing loss is twice as common in people with diabetes as it is in those who do not have the disease. 

          For most people the symptoms of hearing loss can be hard to notice and most of the time, family members and friends notice hearing loss before the person experiencing it. Some research suggests that hearing loss may increase the risk of depression and could explain the higher rate of depression in people with diabetes. As with other types of hearing loss, the earlier it is diagnosed the sooner it can be managed. 

          This study is being done to further explore the impact of type I diabetes on hearing function and to investigate the correlation between hearing loss and duration of diabetes, blood sugar control, and presence of other diabetes complications.

Hypothesis: Hearing loss is more prevalent in type I diabetics who have micro- or macro-vascular complications compared to type I diabetics with no vascular complications.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Dr Mohammed Al-Sofiani

Address

University at Buffalo- CHS
Sisters of Charity Hospital
2157 Main St. 2nd Floor
Buffalo NY 14214

Country

United States of America

Phone

+1 (518)253-9929

Fax

dr_moh2008@hotmail.com

Contact person for public queries

Name

Mohammed Al-Sofiani

Address

University at Buffalo- CHS
Sisters of Charity Hospital
2157 Main St. 2nd Floor
Buffalo NY 14214

Country

United States of America

Phone

+1 (518)253-9929

Fax

dr_moh2008@hotmail.com

Contact person for scientific queries

Name

Mohammed Al-Sofiani

Address

University at Buffalo- CHS
Sisters of Charity Hospital
2157 Main St. 2nd Floor
Buffalo NY 14214

Country

United States of America

Phone

+1 (518)253-9929

Fax

dr_moh2008@hotmail.com

No information has been provided regarding IPD availability

What supporting documents are/will be available?

No Supporting Document Provided

Results publications and other study-related documents

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

Source	Title	Year of Publication	DOI
Embase	Type 1 diabetes and hearing loss: Audiometric assessment and measurement of circulating levels of soluble receptor for advanced glycation end products.	2020	https://dx.doi.org/10.1002/dmrr.3312

N.B. These documents automatically identified may not have been verified by the study sponsor.

Trial Review

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Documents added manually

Documents added automatically