Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT03437135 |
| Other study ID # |
CHU-371 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
December 1, 2015 |
| Est. completion date |
December 14, 2020 |
Study information
| Verified date |
February 2018 |
| Source |
University Hospital, Clermont-Ferrand |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
Diabetes is now the most common chronic disease, affecting nearly 6% of the population in
Western populations. Diabetic neuropathy is a priori the most common and the most common
specific complications of diabetes. It can of course touch the lower limbs, the vegetative
nervous system as well as the cranial nerves. However, the association between hearing
impairment and diabetes has always been controversial on the basis of conflicting literature
data. Are auditory disorders an underestimated complication of diabetes? A meta-analysis made
in 2013, examined the scientific literature between 1950 and 2011 and of the 3158 citations,
only 13 articles were selected. This study found that hearing impairment in diabetic patients
was 2.1 times more prevalent than in non-diabetic matched subjects. In addition, the age /
aging factor is associated with the prevalence of hearing loss and diabetes. However, it also
appears that the link between diabetes and hearing impairment is more pronounced among young
people than older people. In order to document the influence of diabetic pathology on
hearing, Investigator have set up a search audiological exploration platform within the
department of Endocrinology-Diabetology of Clermont-Ferrand University Hospital. It will be
proposed a hearing screening (duration 30 minutes) and a questionnaire to diabetic patients
of the service. In the context of a positive screening, that is to say that one of the tests
carried out reveals the presence of a hearing disorder, an in-depth assessment of the hearing
will be carried out to better characterize the origin of the auditory disturbance (duration
60-90 minutes). These different tests are based on the listening of sounds requiring or not
the participation of patient. Thus, the results of the various tests will make it possible to
classify the impairment of hearing in (1) peripheral impairment (dysfunction of certain cells
of your ear involved in the amplification of sounds), and / or (2) in neural damage
(dysfunction of your auditory nerve).
Description:
Diabetes is now the most common chronic disease since it affects western populations such as
France almost 6% of the population. This disease is particularly costly for social protection
systems, not only for the cost of daily care but also by the occurrence of Chronic
complications that are leading to major co-morbidities. Thus, diabetes is a major
cardiovascular risk factor. Diabetes also leads to micro-angiopathic complications: Diabetic
retinopathy eventually ends up in evolved forms to the first cause of young subject blindness
in developed countries. Nephropathy is one of the first causes of terminal renal failure
leading to extra renal treatment.
Diabetic neuropathy seems to be the most common and the most common of the specific
complications of diabetes. It can of course touch the lower limbs, most often training a
symmetrical and distal motor polyneuritis, responsible for the term of Neuro arthropathy of
Charcot. The vegetative nervous system can also be achieved with cardiovascular,
gastrointestinal, genitourinary, neuro-vascular, metabolic and pupil consequences. The
injuries of the cranial nerves are also possible and are most frequently characterized by
facial paralysis or motor eye nerves.
The association between hearing disorders and diabetes has always aroused controversy on the
part of contradictory literature data. Are hearing disorders an underestimated complication
of diabetes? A recent meta-analysis of 2013, examined the scientific literature between 1950
and 2011 and of the 3158 citations, only 13 articles were selected (with more than 20 000
participants). This study found that hearing disorders in diabetic patients were 2.1 times
more prevalent than in non-diabetic paired subjects. In addition, the age/aging factor is
associated with the prevalence of hearing impairment and diabetes. However, it also appears
that the link between diabetes and hearing disorder is more pronounced among young people
than the elderly.
Nevertheless, it is regrettable that in the majority of the "diabetes-hearing disorders"
studies were not exhaustive from the point of view of the documentation of the alteration of
the hearing function. Indeed, the indices of impairment of the hearing are essentially based
on a review of the audiograms. No more relevant objective test, allowing to evaluate more
precisely the different functional compartments of the inner ear, has been achieved. Indeed,
it would be wise to elucidate which (s) are the targets (s) of the diabetes. Classical
hearing impairment mainly affects cochlear sensory cells and more specifically external hair
cells. However, it is possible to envisage that the alteration of the micro-vascularization
of the vascular Streak (ischemic disorders), a selective expectation of the nerve fibers
(hearing neuropathy), the metabolic disturbances at the mitochondrial level, Oxidative stress
with free radical production, advanced glycation products (AGE, advanced glycation
end-products).
Objectives:
- The primary objective is the assessment of the prevalence of hearing impairment (with or
without clinical manifestation) in a population of type 1 and type 2 diabetic persons
treated and followed during a hospitalization or consultation in the Department of
Endocrinology-Diabetology of the CHU de Clermont-Ferrand.
- The second objectives are:
Identify the proportion of patients with a peripheral explanation for their hearing
impairment (involvement of the outer ciliated cells, 'classic deafness) Identify the
proportion of patients who have a neural explanation for their hearing impairment
(hearing-type neuropathy) And categorize types of hearing impairment by types of diabetes,
its balance, age, absence or absence of complication, age of patient, sex of patient, noise
exposure in a professional manner or as a part of recreation, taking ototoxic drugs, smoking.
