Obesity and Bariatric Surgery According to a Biopsychosocial Perspective.

NCT05950698 | Recruiting FDA Device

• 1 other identifier: 60506922.1.0000.5259
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity; Heart Rate Variability; Anxiety Disorders; Depression; Quality of Life

Keywords

Obesity; Heart rate variability; Anxiety; Depression; Quality of Life

Outcome Measures

Primary Outcomes (4)

• 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

• Bariatric surgery changes measure of anxiety

  Decreased scores on the HAD scale items assessing anxiety

  After 3-6-12-24 months after bariatric surgery

• 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

• 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 Outcomes (1)

• Bariatric surgery changes eating behaviors

  After 3-6-12-24 months after bariatric surgery

Study Arms (1)

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.

Device: Holter Faros 360° EKG (Bittium Corporation); Diagnostic Test: Beck Depression Inventory (BDI); Diagnostic Test: Hospital Anxiety and Depression Scales - HADS; Diagnostic Test: Three Factor Eating Questionnaire-R21 - TFEQ-R21; Diagnostic Test: hort-Form Health Survey-36 itens - SF-36

Interventions

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.

Obese patients submitted to bariatric surgery

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).

Obese patients submitted to bariatric surgery

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).

Obese patients submitted to bariatric surgery

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).

Obese patients submitted to bariatric surgery

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).

Obese patients submitted to bariatric surgery

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Rio de Janeiro State University: lead
• Rio de Janeiro State Research Supporting Foundation (FAPERJ): collaborator
• Universidade Federal Fluminense: collaborator

Study Sites (1)

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

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

RECRUITING

MeSH Terms

Conditions

Obesity; Anxiety Disorders; Depression

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders; Behavioral Symptoms; Behavior

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor - Endocrinology, Department of Internal Medicine - Faculty of Medical Sciences - UERJ

Study Record Dates

• First Submitted: March 27, 2023
• First Posted: July 18, 2023
• Study Start: October 20, 2022
• Primary Completion: October 17, 2024
• Study Completion (Estimated): October 20, 2026
• Last Updated: July 18, 2023

Record last verified: 2023-07

Locations

BR (1)