Actively Recruiting
Obesity and Bariatric Surgery According to a Biopsychosocial Perspective.
Led by Rio de Janeiro State University · Updated on 2023-07-18
50
Participants Needed
1
Research Sites
208 weeks
Total Duration
On this page
Sponsors
R
Rio de Janeiro State University
Lead Sponsor
R
Rio de Janeiro State Research Supporting Foundation (FAPERJ)
Collaborating Sponsor
AI-Summary
What this Trial Is About
* 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
Official Title
Obesity and Bariatric Surgery According to a Biopsychosocial Perspective.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with obesity approved for bariatric surgery
- Signed informed consent
- Men and women aged 18 to 60 years
You will not qualify if you...
- Taking hypoglycemic medications like biguanides, sulfonylureas, glinides, acarbose, GLP-1 analogues, SGLT-2 inhibitors, DPP-IV inhibitors, or insulin
- Taking hyperglycemic medications such as corticoids, high dose thiazide diuretics, beta blockers, diazoxide, or octreotide
- Following very restrictive diets like intermittent fasting or ketogenic diet
- Pregnant women
- History of neurological disorders
- Chronic lung, heart, liver, or kidney diseases
- Currently treated for alcohol or drug abuse
- Smoking
- Severe psychiatric disorders including schizophrenia and bipolar disorder
- Vitamin B12 deficiency, iron-deficiency, or anemia
- Neurodegenerative brain diseases or cerebrovascular diseases
- Refusal to sign informed consent form
AI-Screening
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Trial Site Locations
Total: 1 location
1
Laboratory for Clinical and Experimental Research on Vascular Biology, Rio de Janeiro State University
Rio de Janeiro, Rio de Janeiro, Brazil, Brazil, 20550013
Actively Recruiting
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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