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Motion Perception in Individuals With Type 2 Diabetes

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ClinicalTrials.gov Identifier: NCT03380832
Recruitment Status : Unknown
Verified October 2018 by Faisal_Karmali@MEEI.HARVARD.EDU, Massachusetts Eye and Ear Infirmary.
Recruitment status was:  Recruiting
First Posted : December 21, 2017
Last Update Posted : October 16, 2018
Sponsor:
Information provided by (Responsible Party):
Faisal_Karmali@MEEI.HARVARD.EDU, Massachusetts Eye and Ear Infirmary

Study Description
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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.

Condition or disease
Diabetes Mellitus, Type 2

Detailed 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.

Study Design
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Study Type : Observational
Estimated Enrollment : 16 participants
Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: Vestibular Perception and Action
Actual Study Start Date : August 1, 2017
Estimated Primary Completion Date : June 1, 2019
Estimated Study Completion Date : June 1, 2019

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort
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.


Outcome Measures
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Primary Outcome Measures :
  1. Vestibular threshold [ Time Frame: 3 hours ]
    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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
Any
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03380832


Contacts
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Contact: Faisal Karmali, PhD 4102187614 faisal_karmali@meei.harvard.edu

Locations
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United States, Massachusetts
Massachusetts Eye and Ear Infirmary Recruiting
Boston, Massachusetts, United States, 02114
Contact: Faisal Karmali    410-218-7614    faisal_karmali@meei.harvard.edu   
Sponsors and Collaborators
Massachusetts Eye and Ear Infirmary
Investigators
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Principal Investigator: Faisal Karmali, PhD Massachusetts Eye and Ear Infirmary
More Information
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Responsible Party: Faisal_Karmali@MEEI.HARVARD.EDU, Principal Investigator, Massachusetts Eye and Ear Infirmary
ClinicalTrials.gov Identifier: NCT03380832    
Other Study ID Numbers: 196245
First Posted: December 21, 2017    Key Record Dates
Last Update Posted: October 16, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Diabetes Mellitus, Type 2
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases