The Assessment of Psychophysiological Markers by Analyzing the Heart Rate Variability, Blood Pressure, Anxiety and Depression, Eating Behavior, and Quality of Life Before and After Bariatric Surgery.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Bariatric surgery changes measures of heart rate variability of patients
研究概览
简要总结
- The main goal of this prospective longitudinal observational study is to investigate the psychophysiological indicators by analyzing HRV, blood pressure, symptoms of anxiety and depression, eating behavior and quality of life during the follow-up of the general health status of patients with obesity undergoing the bariatric surgery by Roux-en-Y reconstruction reduction gastroplasty (GRYR) technique.
- The main question it aims to answer is: Does bariatric surgery changes the variables studied (HRV, anxiety, depression, eating behavior, quality of life)?
- Type of study: prospective longitudinal observational study
- Participant population: 50 patients, both females and males, aged between 18 and 60 years, will be submitted to bariatric surgery with Roux-en-Y reconstruction reduction gastroplasty technique.
Patients will be evaluated for five times: before the bariatric surgery and 3-6-12-24 months after the bariatric surgery.
详细描述
Objective: To study the psychophysiological indicators through analysis of heart rate variability (HRV), blood pressure, symptoms of anxiety and depression, eating behavior and quality of life in the follow-up of the general health status of patients with obesity submitted to the bariatric surgery by reduction gastroplasty with Roux-en-Y reconstruction (GRYR).
Methods: The investigators recruited patients of both sexes, aged 18-60 years, for whom bariatric surgery using GRYR techniques is recommended, from the Service of Integral Care for Obesity Sufferers (SAI-Ob) of the Multiuser Clinical Research Center (CePeM) of the Pedro Ernesto University Hospital (HUPE). Those taking hypoglycemic agents (biguanides, sulfonylureas, glinides, acarbose, GLP-1 analogues, SGLT-2 inhibitors, DPP-IV inhibitors, and insulin) and hyperglycemic agents (corticoids high dose thiazide diuretics, beta blockers, diazoxide and octreotide), very restrictive diets (intermittent fasting and ketogenic diet), pregnant women, history of neurological disorder, chronic pulmonary, cardiovascular, hepatic and/or renal diseases, in treatment for alcohol or drug abuse, smoking, severe psychiatric disorders (schizophrenia, bipolar disorder), vitamin B12 deficiency, iron-deficiency, anemia, neurodegenerative or cerebrovascular diseases, and those who refuse to sign the informed consent form.
Eligible patients will have a medical consultation, which will consist of a medical history and physical examination. After the consultation before and after bariatric surgery (after 3-6-12-24 months), patients will perform HRV recording for 15 minutes during a resting condition and then complete the Beck Depression Inventory (BDI), the Hospital Anxiety and Depression Scales (HADS), the Three Factor Eating Questionnaire-R21 (TFEQ-R21), and the Short-Form Health Survey- 36 items (SF-36).
The variables studied are considered to be indices of the health status of patients with obesity. The investigators hope to find changes in the examined psychophysiological measures to accurately guide the diagnostic process of the patient, in order to improve their quality of life and indirectly improve the effectiveness of bariatric surgery.
GOALS
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
- •Obese and liberated patients for the bariatric surgery.
- •informed consent.
- •Males and females between 18 and 60 years old .
排除标准
- •Those taking hypoglycemic medications (biguanides, sulfonylureas, glinides, acarbose, GLP-1 analogues, SGLT-2 inhibitors, DPP-IV inhibitors, and insulin) and hyperglycemic medications (corticoids, high dose thiazide diuretics, beta blockers, diazoxide and octreotide), very restrictive diets (intermittent fasting and ketogenic diet), pregnant women, history of neurological disorder, chronic pulmonary, cardiovascular, hepatic and/or renal diseases, in treatment for alcohol or drug abuse, smoking, severe psychiatric disorders (schizophrenia, bipolar disorder), vitamin B12 deficiency, iron-deficiency, anemia, those with neurodegenerative brain disease or cerebrovascular disease, and those who refuse to sign the informed consent form.
结局指标
主要结局
Bariatric surgery changes measures of heart rate variability of patients
时间窗: After 3-6-12-24 months after bariatric surgery
Increased the parasympathetic activity measured through Respiratory sinus arrhythmia, High and low frequency (time domain measurements), and approximate entropy (non linear measurement) of the heart rate variability. Heart rate variability is recorded through Holter faros 360.
Bariatric surgery changes measure of anxiety
时间窗: After 3-6-12-24 months after bariatric surgery
Decreased scores on the HAD scale items assessing anxiety
Bariatric surgery changes measures of depression
时间窗: After 3-6-12-24 months after bariatric surgery
Decreased scores in the HAD scale and BDI questionnaire assessing depression
Bariatric surgery changes measures of perceived quality of life
时间窗: After 3-6-12-24 months after bariatric surgery
Increased scores in the SF-36 questionnaire which assesses the perceived quality of life
次要结局
- Bariatric surgery changes eating behaviors(After 3-6-12-24 months after bariatric surgery)
研究者
Luiz Guilherme Kraemer-Aguiar, MD
Associate Professor - Endocrinology, Department of Internal Medicine - Faculty of Medical Sciences - UERJ
Rio de Janeiro State University