Vestibular Dysfunction and Glucose Metabolism

NCT ID: NCT02226536

Last Updated: 2022-06-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 51 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-12-31
• Study Completion Date: 2011-12-31

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.

Conditions

Dysfunction of Vestibular System; Glucose Intolerance

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

control

Usual diet without any orientation

Group Type: PLACEBO_COMPARATOR

fractioned diet without glucose

Intervention Type: BEHAVIORAL

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

fractioned diet without glucose

Fractioned diet without glucose

Group Type: ACTIVE_COMPARATOR

fractioned diet without glucose

Intervention Type: BEHAVIORAL

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

Interventions

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

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Sao Paulo General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Roseli Saraiva Moreira Bittar

Assistente Doutor da Faculdade de Medicina da Universidade de São Paulo

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Roseli SM Bittar, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University of São Paulo, Brazil

Other Identifiers

DMG-PDCEAV

Identifier Type: -

Identifier Source: org_study_id