An interventional study of fractioned diet without glucose in Dysfunction of Vestibular System and Glucose Intolerance, sponsored by University of Sao Paulo General Hospital. Completed. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-06-14.
Sponsored by University of Sao Paulo General Hospital · Not applicable, Interventional, and Treatment
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.
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.
778 studies on the registry are indexed under Glucose Intolerance; 129 are open to participants now.
This study's enrollment of 51 is below the median of 60 across 645 interventional studies indexed under Glucose Intolerance.
Browse Glucose Intolerance studies →University of Sao Paulo General Hospital is the lead sponsor of 595 studies on the registry; 98 are open to participants now.
Of its 8 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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Exclusion Criteria:
Usual diet without any orientation
Behavioral: 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
No study locations are listed for this record.
This study is completed, as verified in Jun 2022. You cannot join it, but the record below documents what was studied.
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University of Sao Paulo General Hospital