Influence of the Sleep and Chronotype Pattern in Metabolic, Anthropometric and Biochemical Responses in Patients Submitted to Bariatric Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 122
- 试验地点
- 1
- 主要终点
- Weight in Kg
研究概览
简要总结
The present study has a prospective, longitudinal and observational character, will be performed with patients attending a private clinic specialized in the treatment of obesity and bariatric surgery. Patients to be analyzed should have a medical indication for bariatric surgery.
详细描述
The patients will be selected for ten months and will be monitored for 12 months there are preoperative period, 3 months, 6 months and 12 months after surgery. Anthropometrical evaluation, biochemistry, polysomnography and sleep questionnaire (Epworth and Psqi) and midpoint sleep questionnaires will be performed to classify the chronotype for sleep pattern evaluation.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Agree to participate in the study and sign the Informed Consent Form (EHIC)
- •Patients submitted to By-pass or Sleeve bariatric surgery or Endossleve
- •Patients with BMI above 35 kg / m².
- •Over the age of 18 and up to 60 years.
排除标准
- •Failure to provide the information necessary for the development of the study.
- •Patients undergo revisional surgery
结局指标
主要结局
Weight in Kg
时间窗: Baseline, 3 and 6 months
Anthropometric assessment will be evaluated using weight (kg).
Waist Circumference in Centimeters (cm)
时间窗: Baseline, 3 and 6 months
Anthropometric assessment will be evaluated using waist circumference (cm)
BMI in Kg/m²
时间窗: Baseline, 3 and 6 months
Anthropometric assessment will be evaluated using BMI (kg/m²).
Metabolic Parameters - Insulin (mg/dl)
时间窗: Baseline and 6 months
Metabolic parameters will be evaluated using insulin (mg/dl)
Metabolic Parameters - Homeostasis Model Assessment for Beta-cell Function (HOMA - IR)
时间窗: Baseline and 6 months
Values of metabolic parameters will be evaluated using Homeostasis model assessment for beta-cell function (HOMA - IR) according to the standard assessment measurement in mg/dl. Higher values reflect worse insulin resistance
Metabolic Parameters - High Density Lipoprotein Cholesterol (HDL - mg/dl)
时间窗: Baseline and 6 months
Metabolic parameters will be evaluated using High density lipoprotein cholesterol (HDL - mg/dl)
Metabolic Parameters - Triglycerides (mg/dl)
时间窗: Baseline and 6 months
Metabolic parameters will be evaluated using Triglycerides (mg/dl)
Hip Circumference in Centimeters (cm)
时间窗: Baseline, 3 and 6 months
Anthropometric assessment will be evaluated using hip circumference (cm)
Metabolic Parameters - Cholesterol (mg/dl)
时间窗: Baseline and 6 months
Metabolic parameters will be evaluated using Cholesterol (mg/dl)
Metabolic Parameters - Low Density Lipoprotein Cholesterol (LDL - mg/dl)
时间窗: Baseline and 6 months
Metabolic parameters will be evaluated using low density lipoprotein cholesterol (LDL -mg/dl)
Metabolic Parameters - Very Low Density Lipoprotein Cholesterol (VLDL - mg/dl)
时间窗: Baseline and 6 months
Metabolic parameters will be evaluated using Very low density lipoprotein cholesterol (VLDL - mg/dl)
Neck Circumference in Centimeters (cm)
时间窗: Baseline, 3 and 6 months
Anthropometric assessment will be evaluated using neck circumference (cm)
Metabolic Parameters - Fasting Glucose (mg/dl)
时间窗: Baseline and 6 months
Metabolic parameters will be evaluated using fasting glucose (mg/dl)
次要结局
- Food Consumption - Polyunsaturated Fat (Grams/Day)(Baseline, 3 and 6 months)
- Food Consumption - Calories (Grams/Day)(Baseline, 3 and 6 months)
- Food Consumption - Carbohydrate (Grams/Day)(Baseline, 3 and 6 months)
- Food Consumption - Monounsaturated Fat (Grams/Day)(Baseline, 3 and 6 months)
- Food Consumption - Total Fat (Grams/Day)(Baseline, 3 and 6 months)
研究者
Cibele Aparecida Crispim
Principal Investigator
Federal University of Uberlandia