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Vestibular Dysfunction and Glucose Metabolism

U

University of Sao Paulo General Hospital

Status

Completed

Conditions

Dysfunction of Vestibular System
Glucose Intolerance

Treatments

Behavioral: fractioned diet without glucose

Study type

Interventional

Funder types

Other

Identifiers

NCT02226536
DMG-PDCEAV

Details and patient eligibility

About

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.

Full 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.

Enrollment

51 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

51 participants in 2 patient groups, including a placebo group

control
Placebo Comparator group
Description:
Usual diet without any orientation
Treatment:
Behavioral: fractioned diet without glucose
fractioned diet without glucose
Active Comparator group
Description:
Fractioned diet without glucose
Treatment:
Behavioral: fractioned diet without glucose

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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