Vestibular Dysfunction and Glucose Metabolism

Glucose Intolerance Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02226536
• Other study ID #: DMG-PDCEAV
• Status: Completed
• Phase: N/A
• Start date: December 2005
• Est. completion date: December 2011

Study information

• Verified date: June 2022
• Source: University of Sao Paulo General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 51
• Est. completion date: December 2011
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Dysfunction of Vestibular System
• Glucose Intolerance

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Sao Paulo General Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assessment of equilibrium score through the computerized dynamic posturography (CDP) in 51 patients		30 days
Secondary	Self perception of dizziness mesured by the visual analogue scale		30 days