Obesity and Bariatric Surgery According to a Biopsychosocial Perspective.
NCT ID: NCT05950698
Last Updated: 2023-07-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
50 participants
OBSERVATIONAL
2022-10-20
2026-10-20
Brief Summary
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* 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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Detailed Description
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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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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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 the bariatric surgery and 3-6-12-24 months after the bariatric surgery.
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.
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).
Interventions
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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.
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).
Eligibility Criteria
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Inclusion Criteria
* informed consent.
* Males and females between 18 and 60 years old .
Exclusion Criteria
18 Years
60 Years
ALL
No
Sponsors
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Rio de Janeiro State Research Supporting Foundation (FAPERJ)
OTHER_GOV
Universidade Federal Fluminense
OTHER
Rio de Janeiro State University
OTHER
Responsible Party
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Luiz Guilherme Kraemer-Aguiar, MD
Associate Professor - Endocrinology, Department of Internal Medicine - Faculty of Medical Sciences - UERJ
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
Countries
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Facility Contacts
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Other Identifiers
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60506922.1.0000.5259
Identifier Type: -
Identifier Source: org_study_id
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