Clinical trial NCT05950698: Obesity and Bariatric Surgery According to a Biopsychosocial Perspective.
Official title: 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.
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Obesity
Heart Rate Variability
Anxiety Disorders
Depression
Quality of Life
Keywords: Obesity
Heart rate variability
Anxiety
Depression
Quality of Life
Lead sponsor: Rio de Janeiro State University
Sponsor class: OTHER
Collaborators: name: Rio de Janeiro State Research Supporting Foundation (FAPERJ)
name: Universidade Federal Fluminense
First posted: 2023-07-18
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Obese patients submitted to bariatric surgery:

50 patients, both females and males, aged between 18 and 60 years, who will be submitted to bariatric surgery with Roux-en-Y reconstruction reduction gastroplasty technique.

Patients will be evaluated for five times: before bariatric surgery and 3-6-12-24 months after bariatric surgery.

Brief summary: * 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.

Detailed description: 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

* Study the variables that influence the general health (physical and psychological) of patients with obesity undergoing bariatric surgery;
* Improve the diagnostic process of patients with obesity by integrating psychophysiological indicators;
* Promote interdisciplinarity in the construction of personalized treatments;
* Promote research on HRV as a common factor to verify good or bad health of good or bad health;
* Additionally, the following goals are expected: a) provide training in research for undergraduate, master's and doctoral students who work on the project; b) provide the participation of resident physicians from the Comprehensive Care Service for Obesity Sufferers (SAI-Ob) of HUPE; c) present the results of the study as posters and oral presentations at scientific events; and d) publish scientific articles with the results found in indexed journals.

Eligibility criteria: Inclusion Criteria:

* Obese and liberated patients for the bariatric surgery.
* informed consent.
* Males and females between 18 and 60 years old .

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Bariatric surgery changes measures of heart rate variability of patients
timeFrame: After 3-6-12-24 months after bariatric surgery
measure: Bariatric surgery changes measure of anxiety
timeFrame: After 3-6-12-24 months after bariatric surgery
measure: Bariatric surgery changes measures of depression
timeFrame: After 3-6-12-24 months after bariatric surgery
measure: Bariatric surgery changes measures of perceived quality of life
timeFrame: After 3-6-12-24 months after bariatric surgery
Secondary outcomes:
measure: Bariatric surgery changes eating behaviors
timeFrame: After 3-6-12-24 months after bariatric surgery
Other outcomes:
Locations:
city: Rio De Janeiro
country: Brazil
facility: Laboratory for Clinical and Experimental Research on Vascular Biology, Rio de Janeiro State University
state: Rio De Janeiro, Brazil
Study officials:
References: