Motion Perception in Individuals With Type 2 Diabetes | NCT03380832

Studies
Motion Perception in Individuals With Type 2 Diabetes

NCT03380832

Sponsor

Massachusetts Eye and Ear Infirmary

Status

Unknown status

Last Update Posted

Oct 16, 2018Actual

Enrollment

16Estimated

Phase

Not provided

Conditions

Diabetes Mellitus, Type 2

Interventions

Not provided

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2018

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 1, 2017Actual

Primary Completion Date

Jun 1, 2019Estimated

Completion Date

Jun 1, 2019Estimated

First Submitted Date

Dec 15, 2017

First Submission Date that Met QC Criteria

Dec 19, 2017

First Posted Date

Dec 21, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 15, 2018

Last Update Posted Date

Oct 16, 2018Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

16Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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.

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility 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.

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Any

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Faisal Karmali, PhD	Contact	4102187614		faisal_karmali@meei.harvard.edu

Overall Officials

Name	Affiliation	Role
Faisal Karmali, PhD	Massachusetts Eye and Ear Infirmary	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Massachusetts Eye and Ear Infirmary	Recruiting	Boston	Massachusetts	02114	United States

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

ID	Term
D003920	Diabetes Mellitus
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases