Clinical trial

Obesity and Bariatric Surgery According to a Biopsychosocial Perspective.

Recruiting now · Not applicable · 1 countries · Registry ID NCT05950698

Recruiting nowNot applicableObservational

What this study is about

* 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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age18 Years to 60 Years

SexAll

Healthy volunteersNot accepted

ConditionObesity, Heart Rate Variability, Anxiety Disorders, Depression, Quality of Life

Full registry 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.

Treatments and study arms

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

Bariatric surgery changes measures of heart rate variability of patientsAfter 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 anxietyAfter 3-6-12-24 months after bariatric surgery

Decreased scores on the HAD scale items assessing anxiety

Bariatric surgery changes measures of depressionAfter 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 lifeAfter 3-6-12-24 months after bariatric surgery

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

Study locations

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

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Luiz Guilherme K De Aguiar, PhDContact

Email · Call (+55+21) 23340703

Karynne G Lisboa Lopes dos Santos, PhDContact

Email · Call (+55+21) 23340703

Luiz Guilherme K De Aguiar, PhDPrincipal Investigator