Cerebral Perfusion Changes in Obese Subjects After Administration of 75 Grams of Glucose. A SPECT, Controlled, Blinded and Randomized Study.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Regional cerebral blood flow (rCBF) changes after a meal challenge, measured by Single Single-photon emission computed tomography (SPECT) and statistical parametric mapping.
研究概览
简要总结
This study evaluates the hypothesis that a meal constituted of only glucose produces differences in the brain blood flow in people with obesity that are not observed in people without obesity. These changes, at least in part, could explain the mechanisms involved in maintenance or development of obesity.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Live in Ribeirão Preto, São Paulo - Brazil.
- •Age between 18 and 40 years old.
- •Female gender.
- •Regular menses.
- •Weight inferior than 120 Kg and body mass index (BMI) between 30 and 40 kg/m2, for the group with obesity.
- •BMI between 18,5 and 24,9 kg/m2, for the group without obesity.
排除标准
- •High blood pressure, diabetes, glucose intolerance or impaired fasting glycemia, metabolic syndrome, hypothyroidism and any kidney, liver, heart or neurologic disease.
- •Psychiatric disorders, alcoholism, smoking or illicit drug abuse.
- •Pregnancy or desire to be pregnant
- •Use of medications, excluding contraceptives.
- •Contraindication for magnetic resonance imaging.
- •Be in treatment for obesity.
研究组 & 干预措施
75 grams of glucose plus water solution
In the group with 10 volunteers with obesity, some of them are submitted first to the 75 grams of glucose plus water solution (meal challenge) and in another time to only water.
Also, in the group with 10 volunteers without obesity, some of them are submitted first to the 75 grams of glucose plus water solution (meal challenge) and in another time to only water.
干预措施: 75 grams of glucose plus water solution (Other)
75 grams of glucose plus water solution
In the group with 10 volunteers with obesity, some of them are submitted first to the 75 grams of glucose plus water solution (meal challenge) and in another time to only water.
Also, in the group with 10 volunteers without obesity, some of them are submitted first to the 75 grams of glucose plus water solution (meal challenge) and in another time to only water.
干预措施: Pure water (Other)
Pure water.
In the same group with 10 volunteers with obesity, some of them are submitted first to only water (control) and in another time to the 75 grams of glucose plus water solution (meal challenge).
Also, in the same group with 10 volunteers without obesity, some of them are submitted first to only water (control) and in another time to the 75 grams of glucose plus water solution (meal challenge).
干预措施: 75 grams of glucose plus water solution (Other)
Pure water.
In the same group with 10 volunteers with obesity, some of them are submitted first to only water (control) and in another time to the 75 grams of glucose plus water solution (meal challenge).
Also, in the same group with 10 volunteers without obesity, some of them are submitted first to only water (control) and in another time to the 75 grams of glucose plus water solution (meal challenge).
干预措施: Pure water (Other)
结局指标
主要结局
Regional cerebral blood flow (rCBF) changes after a meal challenge, measured by Single Single-photon emission computed tomography (SPECT) and statistical parametric mapping.
时间窗: 30 minutes after a meal challenge (time of radiopharmaceutical injection)
Using 99m technetium ecd radiopharmaceutical, this study aims to detect rCBF differences between SPECT images performed after a meal challenge composed by 75 grams of glucose and water and also after a challenge constituted by only water (control), both ingested orally. This approach is performed in a group of 10 people with obesity and also in 10 people without obesity.
次要结局
- Blood levels mean differences within both groups, with and without obesity and across these groups, of hormones and metabolites by multiplexed assay using luminex technology and spectrophotometry, respectively.(30 minutes before, at the time and 30, 60 and 90 minutes after the radiopharmaceutical injection.)
- Resting energy expenditure (REE) and body composition measurements by indirect calorimetry and electrical bioimpedance, respectively.(6 hours before SPECT acquisition.)
研究者
Julio Sergio Marchini
Full Professor of Internal Medicine Department at Ribeirão Preto Medical School
University of Sao Paulo