Vestibular Dysfunction and Glucose Metabolism

NCT02226536 | Completed DMC

• 1 other identifier: DMG-PDCEAV
• Study Type: interventional
• Target: 51
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Dysfunction of Vestibular System; Glucose Intolerance

Keywords

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

Outcome Measures

Primary Outcomes (1)

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

  30 days

Secondary Outcomes (1)

• Self perception of dizziness mesured by the visual analogue scale

  30 days

Study Arms (2)

control

PLACEBO COMPARATOR

Usual diet without any orientation

Behavioral: fractioned diet without glucose

fractioned diet without glucose

ACTIVE COMPARATOR

Fractioned diet without glucose

Behavioral: fractioned diet without glucose

Interventions

fractioned diet without glucose 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

control; fractioned diet without glucose

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Sao Paulo General Hospital: lead

MeSH Terms

Conditions

Glucose Intolerance; Vertigo

Interventions

Glucose

Condition Hierarchy (Ancestors)

Hyperglycemia; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Vestibular Diseases; Labyrinth Diseases; Ear Diseases; Otorhinolaryngologic Diseases; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Hexoses; Monosaccharides; Sugars; Carbohydrates

Study Officials

• Roseli SM Bittar, MD, PhD

  University of Sao Paulo

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistente Doutor da Faculdade de Medicina da Universidade de São Paulo

Study Record Dates

• First Submitted: August 6, 2014
• First Posted: August 27, 2014
• Study Start: December 1, 2005
• Primary Completion: December 1, 2010
• Study Completion: December 1, 2011
• Last Updated: June 14, 2022

Record last verified: 2022-06