Investigating the effects of bariatric surgery on obesity and mental health
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.
This study is testing how bariatric surgery affects both weight and mental health in people with obesity by looking at their heart rate, blood pressure, anxiety, depression, eating habits, and quality of life before and after the surgery.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 50 (estimated) |
| Ages | 18 Years to 60 Years |
| Sex | All |
| Sponsor | Rio de Janeiro State University Academic / other |
| Locations | 1 site (Rio de Janeiro, Rio de Janeiro, Brazil) |
| Trial ID | NCT05950698 on ClinicalTrials.gov |
What this trial studies
This observational study aims to explore the psychophysiological effects of bariatric surgery on patients with obesity. It will analyze various indicators such as heart rate variability, blood pressure, anxiety and depression symptoms, eating behavior, and quality of life before and after the surgery. A total of 50 patients aged 18 to 60 will be followed up at multiple intervals: before surgery and at 3, 6, 12, and 24 months post-operation. The study seeks to determine how these variables change as a result of the surgical intervention.
Who should consider this trial
Good fit: Ideal candidates are obese individuals aged 18 to 60 who are eligible for bariatric surgery.
Not a fit: Patients with severe psychiatric disorders, chronic diseases, or those on specific medications may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide insights into the holistic benefits of bariatric surgery, improving both physical and mental health outcomes for patients.
How similar studies have performed: Other studies have shown promising results in understanding the psychosocial impacts of bariatric surgery, making this approach both relevant and potentially impactful.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Rio de Janeiro, Rio de Janeiro, Brazil
- Laboratory for Clinical and Experimental Research on Vascular Biology, Rio de Janeiro State University — Rio de Janeiro, Rio de Janeiro, Brazil, Brazil (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.