Recruiting

Observational Study

Sponsor:

Massachusetts Eye and Ear Infirmary

Code:

NCT03380832

Conditions

Diabetes Mellitus, Type 2

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Study Details

Brief 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.

Conditions

Diabetes Mellitus, Type 2

Study ID

NCT03380832

Start date

Aug 1, 2017

Status verified date

Oct, 2018

Completion date

Jun 1, 2019

Anticipated

Primary completion date

Jun 1, 2019

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

16 participants

Anticipated

Interventions and Outcome Measures

Arms

Type 2 diabetes for at least 10 years

This is an observational study in which we will quantify vestibular thresholds in individuals who have had type 2 diabetes for at least 10 years. Normative data has recently been published and subjects with diabetes will be compared to a model that includes age effects.

Primary outcome measure

  • Vestibular threshold [ Time Frame: 3 hours ]

Central Contacts and Locations

Central contacts

Faisal Karmali, PhD

4102187614faisal_karmali@meei.harvard.edu

Locations

Massachusetts Eye and Ear Infirmary

Recruiting

Boston, Massachusetts, United States, 02114

Contacts

Faisal Karmali

410-218-7614faisal_karmali@meei.harvard.edu

More Information

Sponsor

Massachusetts Eye and Ear Infirmary

Last update posted

Oct 16, 2018

Last verified

Oct, 2018

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Massachusetts Eye and Ear Infirmary on 2018-10-16.