Obesity and Bariatric Surgery According to a Biopsychosocial Perspective.

Obesity Clinical Trial

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05950698
• Other study ID #: 60506922.1.0000.5259
• Status: Recruiting
• Start date: October 20, 2022
• Est. completion date: October 20, 2026

Study information

• Verified date: July 2023
• Source: Rio de Janeiro State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: October 20, 2026
• Est. primary completion date: October 17, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Anxiety Disorders
• Depression
• Depressive Disorder
• Heart Rate Variability
• Obesity
• Quality of Life

Intervention

Device:
• Holter Faros 360° EKG (Bittium Corporation)
Patients will lie down on the examination table, a five-lead ECG will be attached to their chest, and they should rest for 5 minutes before starting the ECG recording. ECG data will be collected for a 15-minute period Heart Rate Variability (HRV) recording will be performed between 09:00 and 12:00 in a fixed examination room to minimize environmental factors and diurnal fluctuations in autonomic nervous system functioning.

Diagnostic Test:
• Beck Depression Inventory (BDI)
The BDI assesses the depression severity. It will be administered before bariatric surgery at time T0 and 3-6-12-24 months after bariatric surgery (T1-T2-T3-T4).
• Hospital Anxiety and Depression Scales - HADS
The HADS assesses the anxiety and depression symptoms. It will be administered before bariatric surgery at time T0 and 3-6-12-24 months after bariatric surgery (T1-T2-T3-T4).
• Three Factor Eating Questionnaire-R21 - TFEQ-R21
The TFEQ-R21assesses the quality of eating behavior. It will be administered before bariatric surgery at time T0 and 3-6-12-24 months after bariatric surgery (T1-T2-T3-T4).
• hort-Form Health Survey-36 itens - SF-36
he TFEQ-R21assesses the quality of life Divided into different areas (functional capacity, general health status, pain, vitality, social aspects, emotional aspects, and mental health). It will be administered before bariatric surgery at time T0 and 3-6-12-24 months after bariatric surgery (T1-T2-T3-T4).

Locations

Country	Name	City	State
Brazil	Laboratory for Clinical and Experimental Research on Vascular Biology, Rio de Janeiro State University	Rio De Janeiro	Rio De Janeiro, Brazil

Sponsors (3)

Lead Sponsor	Collaborator
Rio de Janeiro State University	Rio de Janeiro State Research Supporting Foundation (FAPERJ), Universidade Federal Fluminense

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Bariatric surgery changes measures of heart rate variability of patients	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.	After 3-6-12-24 months after bariatric surgery
Primary	Bariatric surgery changes measure of anxiety	Decreased scores on the HAD scale items assessing anxiety	After 3-6-12-24 months after bariatric surgery
Primary	Bariatric surgery changes measures of depression	Decreased scores in the HAD scale and BDI questionnaire assessing depression	After 3-6-12-24 months after bariatric surgery
Primary	Bariatric surgery changes measures of perceived quality of life	Increased scores in the SF-36 questionnaire which assesses the perceived quality of life	After 3-6-12-24 months after bariatric surgery
Secondary	Bariatric surgery changes eating behaviors	Changes in the scores of the TFEQ-R21 questionnaire	After 3-6-12-24 months after bariatric surgery