ObesityNCT05950698
Obesity and Bariatric Surgery According to a Biopsychosocial Perspective.
An observational study of Obesity and Heart Rate Variability, run by Rio de Janeiro State University at 1 site in Brazil.
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… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Obesity, Heart Rate Variability, Anxiety Disorders
- What is being tested?
- Holter Faros 360° EKG (Bittium Corporation), Beck Depression Inventory (BDI) and Hospital Anxiety and Depression Scales - HADS
- Type of treatment
- Medical device
- How many people
- 50 participants
- Where
- 1 siteBrazil
- Study dates
- 20 Oct 2022to 20 Oct 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
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.
Who may be able to join
- Obese and liberated patients for the bariatric surgery.
- informed consent.
- Males and females between 18 and 60 years old .
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Laboratory for Clinical and Experimental Research on Vascular Biology, Rio de Janeiro State University
Rio de Janeiro, Rio de Janeiro, Brazil, 20550013
Luiz Guilherme K De Aguiar, PhD, (+55+21) 23340703, lgkraemeraguiar@gmail.com
Karynne G Lisboa Lopes dos Santos, PhD, (+55+21) 23340703, kjgolrj@gmail.com
About this study
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.
- 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.
Read the detailed 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.
- Conditions
- Obesity, Heart Rate Variability, Anxiety Disorders, Depression, Quality of Life
- Being tested
- Holter Faros 360° EKG (Bittium Corporation), Beck Depression Inventory (BDI), Hospital Anxiety and Depression Scales - HADS, Three Factor Eating Questionnaire-R21 - TFEQ-R21, hort-Form Health Survey-36 itens - SF-36
- Keywords
- Obesity, Heart rate variability, Anxiety, Depression, Quality of Life
- Medical subject headings
- Obesity, Anxiety Disorders, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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 - HADSDiagnostic 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-R21Diagnostic 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-36Diagnostic 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).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: After 3-6-12-24 months after bariatric surgery
Bariatric surgery changes measure of anxiety
Decreased scores on the HAD scale items assessing anxiety
Measured: 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
Measured: 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
Measured: After 3-6-12-24 months after bariatric surgery
Secondary outcomes (1)
Bariatric surgery changes eating behaviors
Changes in the scores of the TFEQ-R21 questionnaire
Measured: After 3-6-12-24 months after bariatric surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2023
- Study start20 Oct 2022
- Primary completion17 Oct 2024 (estimated)
- Study completion20 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rio de Janeiro State University
- Sponsor type
- University, hospital or other
- Collaborators
- Rio de Janeiro State Research Supporting Foundation (FAPERJ), Universidade Federal Fluminense
- Responsible party
- Principal investigator, Luiz Guilherme Kraemer-Aguiar, MD, Rio de Janeiro State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05950698
- Sponsor's protocol ID
- 60506922.1.0000.5259
- Status last verified
- Jul 2023
- First submitted
- 27 Mar 2023
- Last updated
- 18 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT05950698
- Acronym / sponsor ID
- 60506922.1.0000.5259
- Conditions
- Obesity, Heart Rate Variability, Anxiety Disorders, Depression, Quality of Life
- Keywords
- Obesity, Heart rate variability, Anxiety, Depression, Quality of Life
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Rio de Janeiro State UniversityUniversity, hospital or other
- Collaborators
- Rio de Janeiro State Research Supporting Foundation (FAPERJ), Universidade Federal Fluminense
- Study start
- 20 Oct 2022 (actual)
- Primary completion
- 17 Oct 2024 (estimated)
- Study completion
- 20 Oct 2026 (estimated)
- First posted
- 18 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- 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.
Detailed 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Obese patients submitted to 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-3650 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. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (3 listed)
- Obese and liberated patients for the bariatric surgery.
- informed consent.
- Males and females between 18 and 60 years old .
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Device | Obese patients submitted to bariatric surgery |
| 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). | Diagnostic test | Obese patients submitted to bariatric surgery |
| Hospital Anxiety and Depression Scales - HADSThe 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). | Diagnostic test | Obese patients submitted to bariatric surgery |
| Three Factor Eating Questionnaire-R21 - TFEQ-R21The 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). | Diagnostic test | Obese patients submitted to bariatric surgery |
| hort-Form Health Survey-36 itens - SF-36he 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). | Diagnostic test | Obese patients submitted to bariatric surgery |
Primary outcome
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.
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
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
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
1 secondary outcome
Bariatric surgery changes eating behaviors
Time frame: After 3-6-12-24 months after bariatric surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2023.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Laboratory for Clinical and Experimental Research on Vascular Biology, Rio de Janeiro State University
Rio de Janeiro, Brazil
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obesity and Heart Rate Variability, run by Rio de Janeiro State University at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bariatric surgery changes measures of heart rate variability of patients (time frame: After 3-6-12-24 months after bariatric surgery). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jul 2023.