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Vestibular Dysfunction and Glucose Metabolism

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ClinicalTrials.gov Identifier: NCT02226536
Recruitment Status : Completed
First Posted : August 27, 2014
Last Update Posted : August 27, 2014
Sponsor:
Information provided by (Responsible Party):
Roseli Saraiva Moreira Bittar, University of Sao Paulo General Hospital

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.

Condition or disease Intervention/treatment Phase
Dysfunction of Vestibular System Glucose Intolerance Behavioral: fractioned diet without glucose Not Applicable

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  (Clinical Trial)
Actual Enrollment : 51 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Fractionated and Restrictive Glucose Diet in Patients With Vestibular Dysfunction: a Randomized Controlled Trial
Study Start Date : December 2005
Actual Primary Completion Date : December 2010
Actual Study Completion Date : December 2011

Resource links provided by the National Library of Medicine

Drug Information available for: Dextrose

Arm Intervention/treatment
Placebo Comparator: control
Diet group Control group
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




Primary Outcome Measures :
  1. Assessment of equilibrium score through the computerized dynamic posturography (CDP) in 51 patients [ Time Frame: 30 days ]

Secondary Outcome Measures :
  1. Self perception of dizziness mesured by the visual analogue scale [ Time Frame: 30 days ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02226536


Sponsors and Collaborators
University of Sao Paulo General Hospital
Investigators
Principal Investigator: Roseli Bittar, MD, PhD University of São Paulo, Brazil

Responsible Party: Roseli Saraiva Moreira Bittar, Assistente Doutor da Faculdade de Medicina da Universidade de São Paulo, University of Sao Paulo General Hospital
ClinicalTrials.gov Identifier: NCT02226536     History of Changes
Other Study ID Numbers: DMG-PDCEAV
First Posted: August 27, 2014    Key Record Dates
Last Update Posted: August 27, 2014
Last Verified: August 2014

Keywords provided by Roseli Saraiva Moreira Bittar, University of Sao Paulo General Hospital:
Posture
Vertigo
glucose metabolism
diet
scales
dinamic posturography

Additional relevant MeSH terms:
Glucose Intolerance
Hyperglycemia
Glucose Metabolism Disorders
Metabolic Diseases