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Search / Trial NCT05950698

Obesity and Bariatric Surgery According to a Biopsychosocial Perspective.

Launched by RIO DE JANEIRO STATE UNIVERSITY · Jul 10, 2023

Trial Information

Current as of August 19, 2025

Recruiting

Keywords

Obesity Heart Rate Variability Anxiety Depression Quality Of Life

ClinConnect Summary

This clinical trial is studying how bariatric surgery, specifically a technique called Roux-en-Y gastric bypass, affects various aspects of health in people with obesity. Researchers want to see if this surgery can lead to improvements in heart rate variability (how well the heart responds to stress), anxiety, depression, eating habits, and overall quality of life. The trial will follow 50 participants, both men and women aged 18 to 60, before the surgery and then again at 3, 6, 12, and 24 months after the procedure to track these changes.

To be eligible for this study, participants need to be obese and cleared for surgery, and they must be willing to give their consent. However, individuals who are taking certain medications, have severe health issues, or are pregnant cannot participate. Throughout the study, participants can expect regular check-ins to assess their mental and physical health and how their lives change after the surgery. The goal is to better understand the broader impacts of bariatric surgery beyond just weight loss.

Gender

ALL

Eligibility criteria

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

About Rio De Janeiro State University

Rio de Janeiro State University (UERJ) is a prominent academic institution in Brazil, recognized for its commitment to advancing research and education across various disciplines, including health sciences. As a clinical trial sponsor, UERJ leverages its extensive resources and expertise to facilitate innovative research initiatives aimed at improving healthcare outcomes. With a focus on interdisciplinary collaboration, the university engages in cutting-edge studies that address critical health challenges, ensuring adherence to ethical standards and regulatory requirements. UERJ's dedication to fostering scientific inquiry and community health makes it a vital contributor to the landscape of clinical research in Brazil and beyond.

Locations

Rio De Janeiro, Rio De Janeiro, Brazil, Brazil

Rio De Janeiro, , Brazil

Patients applied

0 patients applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported