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Vestibular Dysfunction and Glucose Metabolism

Primary Purpose

Dysfunction of Vestibular System, Glucose Intolerance

Status

Completed

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

fractioned diet without glucose

About this trial

This is an interventional treatment trial for Dysfunction of Vestibular System focused on measuring Posture, Vertigo, glucose metabolism, diet, scales, dinamic posturography

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

dizziness related to fasting or glucose intake
alterations of glucose tolerance test

Exclusion Criteria:

dizziness not related to vestibular problems
ortopedical or neurological diseases
diabetes mellitus

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

control

fractioned diet without glucose

Arm Description

Usual diet without any orientation

Fractioned diet without glucose

Outcomes

Primary Outcome Measures

Assessment of equilibrium score through the computerized dynamic posturography (CDP) in 51 patients

Secondary Outcome Measures

Self perception of dizziness mesured by the visual analogue scale

Full Information

NCT ID

NCT02226536

First Posted

August 6, 2014

Last Updated

June 9, 2022

Sponsor

University of Sao Paulo General Hospital

1. Study Identification

Unique Protocol Identification Number

NCT02226536

Brief Title

Vestibular Dysfunction and Glucose Metabolism

Official Title

Fractionated and Restrictive Glucose Diet in Patients With Vestibular Dysfunction: a Randomized Controlled Trial

Study Type

Interventional

2. Study Status

Record Verification Date

June 2022

Overall Recruitment Status

Completed

Study Start Date

December 2005 (undefined)

Primary Completion Date

December 2010 (Actual)

Study Completion Date

December 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Sao Paulo General Hospital

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

Introduction: the global sugar consumption has increased in the past 50 years and their abusive intake is responsible for the insulin resistance and causes the metabolic syndrome - obesity, diabetes mellitus, hypertension and coronary heart disease. Objective: To evaluate the effect of scheduled diet without glucose as treatment of labyrinthine disorders associated with glucose-insulin index. Study Design: A prospective randomized controlled trial. Patients and Methods: A study conducted at the University of São Paulo with 51 patients divided into two groups: Diet Group (DG) that comprises subjects treated with fractionated diet with glucose restriction and control group (CG) where individuals were not counseled regarding diet. Patients underwent computerized dynamic posturography - sensory organization test (CDP - SOT) and Visual Analog Scale (VAS) in the first and thirtieth days of the study.

Detailed Description

51 patientes with dizziness and glucose intolerance diagnosed by the glucose tolerance test were selected. The subjects were submited to CDP SOT conditions and a visual analogue scale to measure his self perception about dizziness. Then, they were randomized in two groups: with and without fractioned diet without glucose during 30 days. The CDP was repeated in order to verify a statistical difference of SOT condition 5 that reflects the individual hability to maintain the own posture with the vestibule solely and CS - that represents the final balance situation. The VAS was repeated too in order to verify the self perception of the dizziness after diet.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Dysfunction of Vestibular System, Glucose Intolerance

Keywords

Posture, Vertigo, glucose metabolism, diet, scales, dinamic posturography

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Participant

Allocation

Randomized

Enrollment

51 (Actual)

8. Arms, Groups, and Interventions

Arm Title

control

Arm Type

Placebo Comparator

Arm Description

Usual diet without any orientation

Arm Title

fractioned diet without glucose

Arm Type

Active Comparator

Arm Description

Fractioned diet without glucose

Intervention Type

Behavioral

Intervention Name(s)

fractioned diet without glucose

Intervention Description

Patients were divided into two groups: Diet Group was treated with placebo pills and glucose restrictive and fractionated diet. Control Group received only placebo pills. All individuals had their vestibular function evaluated by Computerized Dynamic Posturography and done visual analogue scale (VAS) in the first day and 30 days after diet intervention

Primary Outcome Measure Information:

Title

Assessment of equilibrium score through the computerized dynamic posturography (CDP) in 51 patients

Time Frame

30 days

Secondary Outcome Measure Information:

Title

Self perception of dizziness mesured by the visual analogue scale

Time Frame

30 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: dizziness related to fasting or glucose intake alterations of glucose tolerance test Exclusion Criteria: dizziness not related to vestibular problems ortopedical or neurological diseases diabetes mellitus

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Roseli SM Bittar, MD, PhD

Organizational Affiliation

University of São Paulo, Brazil

Official's Role

Principal Investigator

12. IPD Sharing Statement

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Vestibular Dysfunction and Glucose Metabolism

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