Motion Perception in Individuals With Type 2 Diabetes

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

Vestibular Perception and Action

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03380832
• Other study ID #: 196245
• Status: Recruiting
• Start date: August 1, 2017
• Est. completion date: June 1, 2019

Study information

• Verified date: October 2018
• Source: Massachusetts Eye and Ear Infirmary
• Contact: Faisal Karmali, PhD
• Phone: 4102187614
• Email: faisal_karmali[@]meei.harvard.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Is the ability to perceive motion altered by diabetes? The investigators are measuring motion perception using a technique called vestibular thresholds. Subjects will undergo 3 hours of testing in which they sit in a chair that makes small movements and report their perception of motion. The investigators are currently looking for individuals who have had type 2 diabetes for at least 10 years.

Description:

Previous studies have found that individuals with diabetes fall more frequently, have less stable posture, and have reduced motion and touch sensation in the lower extremities. This study will examine whether vestibular sensation is also affected by diabetes.

This study is observational because measurements will be made without the application of an intervention. The same measurement protocol was applied to a large group of normal subjects, and this published data will serve as normative controls.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 16
• Est. completion date: June 1, 2019
• Est. primary completion date: June 1, 2019
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Type 2 diabetes for at least 10 years

• Under 250 pounds

Exclusion Criteria:

• Medications not to be used include: Ambien (Zolpidem), Antivert, Bonine (Meclizine), Ativan (Lorazepam), Benadryl (diphenhydramine), Dalmane (Flurazepam), Dramamine, Doral (Quazepam), Fiorinal, Fiorcet (Butalbital), Halcion (Triazolam), Klonopin (Clonazepam), Librium, Librax (Chlordiazepoxide), Nembutal (Pentobarbital), Phenergan (Promethazine), Placidyl (Ethchlorvynol), Prosom (Estazolam), Restoril (Temazepam), Seconal (Secobarbital), Serax (Oxazepam), Transderm Scopes Patch, Vontrol (Diphenidol), Xanax (Alprazolam).

• Individuals meeting the following criteria will be excluded: a) a history of head trauma, b) posterior fossa pathology, c) a well-defined otologic diagnosis (e.g., Benign Paroxysmal Positional Vertigo (BPPV), Meniere's disease, superior canal dehiscence, etc., unilateral or bilateral vestibular hypofunction) d) a recent history of seizures e) any other major neurologic (e.g., Parkinson's, Multiple Sclerosis, dementia, epilepsy, cerebellar ataxia, stroke, recent concussion, etc.) disorder, f) any major psychiatric (e.g., panic disorder, psychosis, etc.) disorder, and g) any other severe health problem (heart disease, pulmonary disease, cancer, etc.).

• Due to nauseogenic nature of some motions and to protect fetus and mother, pregnant women will also be excluded from this study.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Locations

Country	Name	City	State
United States	Massachusetts Eye and Ear Infirmary	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Massachusetts Eye and Ear Infirmary

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Vestibular threshold	Vestibular thresholds are measured while subjects sit in a chair that makes small motions in a variety of directions. After each motion, subjects press a button to report their perceived direction (e.g., did I rotate to the left or the right). The size of the motions is adjusted based on subject responses to find the level at which they get approximately 80% of responses correct.	3 hours