Vestibular Dysfunction and Glucose Metabolism

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Dysfunction of Vestibular System, Glucose Intolerance

Intervention / Treatment
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* Behavioral: fractioned diet without glucose


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: control<br>Usual diet without any orientation | Behavioral: fractioned diet without glucose<br>* 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<br>|
| Active Comparator: fractioned diet without glucose<br>Fractioned diet without glucose | Behavioral: fractioned diet without glucose<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of equilibrium score through the computerized dynamic posturography (CDP) in 51 patients |  | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Self perception of dizziness mesured by the visual analogue scale |  | 30 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Posture, Vertigo, glucose metabolism, diet, scales, dinamic posturography