Vestibular Dysfunction and Glucose Metabolism

Not Applicable

Completed

• Conditions: Glucose Intolerance; Dysfunction of Vestibular System
• Interventions: Behavioral: fractioned diet without glucose

• Registration Number: NCT02226536
• Lead Sponsor: University of Sao Paulo General Hospital

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.

Study Timeline

• Study Start: 2005-12
• Primary Completion: 2010-12
• Study Completion: 2011-12
• Study First Submitted: 2014-08-06
• Study First Submitted QC: 2014-08-26
• Study First Posted: 2014-08-27
• Status Verified: 2022-06
• Last Update Submitted: 2022-06-09
• Last Update Posted: 2022-06-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 51

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
control	fractioned diet without glucose	Usual diet without any orientation
fractioned diet without glucose	fractioned diet without glucose	Fractioned diet without glucose

Primary Outcome Measures

Name	Time	Method
Assessment of equilibrium score through the computerized dynamic posturography (CDP) in 51 patients	30 days

Secondary Outcome Measures

Name	Time	Method
Self perception of dizziness mesured by the visual analogue scale	30 days