Vestibular Dysfunction and Glucose Metabolism

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

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.

Study Overview

• Status: Completed
• Conditions: Glucose Intolerance; Dysfunction of Vestibular System
• Intervention / Treatment: Behavioral: fractioned diet without glucose

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 Type: Interventional
• Enrollment (Actual): 51
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: control; Usual diet without any orientation	Behavioral: fractioned diet without glucose; 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
Active Comparator: fractioned diet without glucose; Fractioned diet without glucose	Behavioral: fractioned diet without glucose; 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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University of Sao Paulo General Hospital
• Investigators: Principal Investigator: Roseli SM Bittar, MD, PhD, University of São Paulo, Brazil

Study record dates

Study Major Dates

• Study Start: December 1, 2005
• Primary Completion (Actual): December 1, 2010
• Study Completion (Actual): December 1, 2011

Study Registration Dates

• First Submitted: August 6, 2014
• First Submitted That Met QC Criteria: August 26, 2014
• First Posted (Estimate): August 27, 2014

Study Record Updates

• Last Update Posted (Actual): June 14, 2022
• Last Update Submitted That Met QC Criteria: June 9, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Keywords: Posture; diet; Vertigo; glucose metabolism; scales; dinamic posturography
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Hyperglycemia; Glucose Intolerance
• Other Study ID Numbers: DMG-PDCEAV