Obesity and Bariatric Surgery According to a Biopsychosocial Perspective.
Recruiting now
Conditions studied: Obesity, Heart Rate Variability, Anxiety Disorders, Depression, Quality of Life
In brief
* 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.
Key facts
- Study ID
- NCT05950698
- Run by
- Rio de Janeiro State University
- People needed
- 50
- Starts
- 2022-10-20
- Expected to finish
- 2026-10-20
- Last updated by the study team
- 2023-07-18
Who can join
Age: 18 and older, up to 60. Sex: any. Healthy volunteers: not accepted.
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.
Where it is running
- Laboratory for Clinical and Experimental Research on Vascular Biology, Rio de Janeiro State University — Rio de Janeiro, Rio de Janeiro, Brazil, Brazil (enrolling)
Full record on ClinicalTrials.gov
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