Obesity and Bariatric Surgery According to a Biopsychosocial Perspective.
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-60
SponsorRio de Janeiro State University
About this trial
* 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.
Eligibility criteria
Qualifiers
Obese and liberated patients for the bariatric surgery.
informed consent.
Males and females between 18 and 60 years old .
Disqualifiers
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 design
Treatments tested in this trial
- 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
Treatment groups
50 Participants
are divided into 1 treatment groupSponsors and collaborators
Rio de Janeiro State University
Lead sponsor
Rio de Janeiro State Research Supporting Foundation (FAPERJ)
Collaborator
Universidade Federal Fluminense
Collaborator
Source ClinicalTrials.gov