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NCT Number: NCT05950698

Obesity and Bariatric Surgery According to a Biopsychosocial Perspective.

* 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.

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Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Laboratory for Clinical and Experimental Research on Vascular Biology, Rio de Janeiro State University

Rio de Janeiro, Rio de Janeiro, Brazil, 20550013, Brazil

Location status: Recruiting

Location contact

Camilla Guccione, PhD

SUB_INVESTIGATOR

Daniel Sant'Anna da Silva, PhD

SUB_INVESTIGATOR

Eliete Bouskela, PhD

SUB_INVESTIGATOR

Karynne G Lisboa Lopes dos Santos, PhD

CONTACT

[email protected]

(+55+21) 23340703

Karynne G Lisboa Lopes dos Santos, PhD

SUB_INVESTIGATOR

Luiz Guilherme K De Aguiar, PhD

CONTACT

[email protected]

(+55+21) 23340703

Luiz Guilherme K De Aguiar, PhD

PRINCIPAL_INVESTIGATOR

Pedro P da Silva Soares, PhD

SUB_INVESTIGATOR

Roberto Sirgni, Dr

SUB_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Holter Faros 360° EKG (Bittium Corporation)

Device

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.

Beck Depression Inventory (BDI)

Diagnostic Test

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

Diagnostic Test

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

Diagnostic Test

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

Diagnostic Test

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).

Primary outcomes

  1. Bariatric surgery changes measures of heart rate variability of patients

    Time frame: 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.

  2. Bariatric surgery changes measure of anxiety

    Time frame: After 3-6-12-24 months after bariatric surgery

    Decreased scores on the HAD scale items assessing anxiety

  3. Bariatric surgery changes measures of depression

    Time frame: After 3-6-12-24 months after bariatric surgery

    Decreased scores in the HAD scale and BDI questionnaire assessing depression

  4. Bariatric surgery changes measures of perceived quality of life

    Time frame: After 3-6-12-24 months after bariatric surgery

    Increased scores in the SF-36 questionnaire which assesses the perceived quality of life

Secondary outcomes

  1. Bariatric surgery changes eating behaviors

    Time frame: After 3-6-12-24 months after bariatric surgery

    Changes in the scores of the TFEQ-R21 questionnaire

Sponsors and collaborators

Lead sponsor

Rio de Janeiro State University

Other

Collaborators

  • Rio de Janeiro State Research Supporting Foundation (FAPERJ)
  • Universidade Federal Fluminense

Registry information

Official study 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.

Important dates

Study start
2022
Primary completion
2024
Study completion
2026
First posted
Jul 18, 2023
Registry last updated
Jul 18, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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