Dysfunction of Vestibular SystemNCT02226536
Vestibular Dysfunction and Glucose Metabolism
A study testing fractioned diet without glucose in people with Dysfunction of Vestibular System and Glucose Intolerance, run by University of Sao Paulo General Hospital.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dysfunction of Vestibular System, Glucose Intolerance
- What is being tested?
- fractioned diet without glucose
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 51 participants
- Where
- No sites listed yet
- Study dates
- Dec 2005to Dec 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- dizziness related to fasting or glucose intake
- alterations of glucose tolerance test
Who cannot join
- dizziness not related to vestibular problems
- ortopedical or neurological diseases
- diabetes mellitus
About this study
Official title: Fractionated and Restrictive Glucose Diet in Patients With Vestibular Dysfunction: a Randomized Controlled Trial
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.
Read the 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.
- Being tested
- fractioned diet without glucose
- Keywords
- Posture, Vertigo, glucose metabolism, diet, scales, dinamic posturography
- Medical subject headings
- Glucose Intolerance, Vertigo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fractioned diet without glucoseBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| control | Placebo comparator | Usual diet without any orientation Receives: Behavioral: fractioned diet without glucose |
| fractioned diet without glucose | Active comparator | Fractioned diet without glucose Receives: Behavioral: fractioned diet without glucose |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of equilibrium score through the computerized dynamic posturography (CDP) in 51 patients
Measured: 30 days
Secondary outcomes (1)
Self perception of dizziness mesured by the visual analogue scale
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2014 (estimated)
- Study startDec 2005
- Primary completionDec 2010
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dysfunction of Vestibular SystemStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Roseli Saraiva Moreira Bittar, University of Sao Paulo General Hospital
- Investigators
- Roseli SM Bittar, MD, PhD, Principal investigator, University of Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02226536
- Sponsor's protocol ID
- DMG-PDCEAV
- Status last verified
- Jun 2022
- First submitted
- 6 Aug 2014
- Last updated
- 14 Jun 2022
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fractionated and Restrictive Glucose Diet in Patients With Vestibular Dysfunction: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02226536
- Acronym / sponsor ID
- DMG-PDCEAV
- Keywords
- Posture, Vertigo, glucose metabolism, diet, scales, dinamic posturography
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- University of Sao Paulo General HospitalUniversity, hospital or other
- Study start
- Dec 2005
- Primary completion
- Dec 2010 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 27 Aug 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control | Placebo comparator | Behavioral: fractioned diet without glucoseUsual diet without any orientation |
| fractioned diet without glucose | Active comparator | Behavioral: fractioned diet without glucoseFractioned diet without glucose |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- dizziness related to fasting or glucose intake
- alterations of glucose tolerance test
Key exclusion criteria (3 listed)
- dizziness not related to vestibular problems
- ortopedical or neurological diseases
- diabetes mellitus
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| fractioned diet without glucosePatients 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 | Behavioural | control, fractioned diet without glucose |
Primary outcome
Assessment of equilibrium score through the computerized dynamic posturography (CDP) in 51 patients
Time frame: 30 days
1 secondary outcome
Self perception of dizziness mesured by the visual analogue scale
Time frame: 30 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jun 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Roseli SM Bittar, MD, PhD principal investigator
University of Sao Paulo
Questions about this trial
What is this clinical trial studying?
A study testing fractioned diet without glucose in people with Dysfunction of Vestibular System and Glucose Intolerance, run by University of Sao Paulo General Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of equilibrium score through the computerized dynamic posturography (CDP) in 51 patients (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jun 2022.