Trial Review

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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] 286159 0
Nil
Universal Trial Number (UTN)
Trial acronym
DHL
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hearing Loss 294169 0
Diabetes Mellitus 294611 0
Condition category
Condition code
Metabolic and Endocrine 294497 294497 0 0
Diabetes
Ear 294912 294912 0 0
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] 291166 0
Not applicable
Comparator / control treatment
None
Control group
Uncontrolled

Outcomes
Primary outcome [1] 294274 0
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] 294274 0
At baseline (one visit study)
Secondary outcome [1] 312933 0
To evaluate the correlation between hearing loss and hemoglobin A1C in type I DM.
Timepoint [1] 312933 0
At baseline (one visit study)
Secondary outcome [2] 313832 0
To evaluate the correlation between hearing loss and duration of diabetes in type I DM.
Timepoint [2] 313832 0
At baseline (one visit study)
Secondary outcome [3] 313833 0
To evaluate the correlation between hearing loss and serum levels of sRAGE in type I DM.
Timepoint [3] 313833 0
At baseline (one visit study)
Secondary outcome [4] 313834 0
To evaluate the correlation between hearing loss and urinary levels of oxidative stress biomarkers such as isoprostanes.
Timepoint [4] 313834 0
At baseline (one visit study)
Secondary outcome [5] 313835 0
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] 313835 0
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?
No
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
60
Accrual to date
Final
Recruitment outside Australia
Country [1] 6656 0
United States of America
State/province [1] 6656 0
NY

Funding & Sponsors
Funding source category [1] 290731 0
Self funded/Unfunded
Name [1] 290731 0
Country [1] 290731 0
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] 289421 0
None
Name [1] 289421 0
Address [1] 289421 0
Country [1] 289421 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 292368 0
University at Buffalo Institutional Review Board (UBIRB)
Ethics committee address [1] 292368 0
Office of Research Compliance | Clinical and Translational Research Center Room 5018 875 Ellicott St. | Buffalo, NY 142303
Ethics committee country [1] 292368 0
United States of America
Date submitted for ethics approval [1] 292368 0
06/11/2014
Approval date [1] 292368 0
13/11/2014
Ethics approval number [1] 292368 0

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 54862 0
Dr Mohammed Al-Sofiani
Address 54862 0
University at Buffalo- CHS
Sisters of Charity Hospital
2157 Main St. 2nd Floor
Buffalo NY 14214
Country 54862 0
United States of America
Phone 54862 0
+1 (518)253-9929
Fax 54862 0
Email 54862 0
[email protected]
Contact person for public queries
Name 54863 0
Dr Mohammed Al-Sofiani
Address 54863 0
University at Buffalo- CHS
Sisters of Charity Hospital
2157 Main St. 2nd Floor
Buffalo NY 14214
Country 54863 0
United States of America
Phone 54863 0
+1 (518)253-9929
Fax 54863 0
Email 54863 0
[email protected]
Contact person for scientific queries
Name 54864 0
Dr Mohammed Al-Sofiani
Address 54864 0
University at Buffalo- CHS
Sisters of Charity Hospital
2157 Main St. 2nd Floor
Buffalo NY 14214
Country 54864 0
United States of America
Phone 54864 0
+1 (518)253-9929
Fax 54864 0
Email 54864 0
[email protected]

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
SourceTitleYear of PublicationDOI
EmbaseType 1 diabetes and hearing loss: Audiometric assessment and measurement of circulating levels of soluble receptor for advanced glycation end products.2020https://dx.doi.org/10.1002/dmrr.3312
N.B. These documents automatically identified may not have been verified by the study sponsor.