Vestibular Dysfunction and Glucose Metabolism
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02226536|
Recruitment Status : Completed
First Posted : August 27, 2014
Last Update Posted : August 27, 2014
|Condition or disease||Intervention/treatment||Phase|
|Dysfunction of Vestibular System Glucose Intolerance||Behavioral: fractioned diet without glucose||Not Applicable|
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|
|Intervention Model:||Parallel Assignment|
|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|
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
- Assessment of equilibrium score through the computerized dynamic posturography (CDP) in 51 patients [ Time Frame: 30 days ]
- Self perception of dizziness mesured by the visual analogue scale [ Time Frame: 30 days ]
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
|Principal Investigator:||Roseli Bittar, MD, PhD||University of São Paulo, Brazil|