Fractionated and Restrictive Glucose Diet in Patients With Vestibular Dysfunction: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 51
- 主要终点
- Assessment of equilibrium score through the computerized dynamic posturography (CDP) in 51 patients
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •dizziness related to fasting or glucose intake
- •alterations of glucose tolerance test
排除标准
- •dizziness not related to vestibular problems
- •ortopedical or neurological diseases
- •diabetes mellitus
结局指标
主要结局
Assessment of equilibrium score through the computerized dynamic posturography (CDP) in 51 patients
时间窗: 30 days
次要结局
- Self perception of dizziness mesured by the visual analogue scale(30 days)
研究者
Roseli Saraiva Moreira Bittar
Assistente Doutor da Faculdade de Medicina da Universidade de São Paulo
University of Sao Paulo General Hospital