Evaluating copeptin and thirst as predictors of bariatric surgery effectiveness
Copeptin and Thirst: Possible Predictive Markers of Effectiveness of Bariatric Surgery?
This study is trying to see if measuring copeptin levels and thirst can help predict how well bariatric surgery works for people with obesity.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 30 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | IRCCS Azienda Ospedaliero-Universitaria di Bologna Academic / other |
| Locations | 1 site (Bologna, Bologna) |
| Trial ID | NCT06806787 on ClinicalTrials.gov |
What this trial studies
This observational study aims to assess the relationship between copeptin levels and thirst in patients undergoing bariatric surgery for obesity. It will involve monitoring patients over a 12-month period through laboratory tests and imaging studies, including abdominal ultrasonography. The study will evaluate the potential of copeptin as a predictive marker for the effectiveness of the surgical intervention. Participants will be followed up according to standard clinical practices after the initial study period.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 to 65 with a BMI of 40 or higher, or a BMI of 35 or higher with at least one comorbidity.
Not a fit: Patients with severe psychiatric illnesses, substance abuse issues, or other specific medical conditions that contraindicate bariatric surgery may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could help identify patients who are more likely to benefit from bariatric surgery, leading to improved outcomes.
How similar studies have performed: While the approach of using copeptin as a predictive marker is relatively novel, similar studies exploring biomarkers in obesity treatment have shown promise.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * BMI ≥ 40 in the absence of comorbidities; BMI ≥ 35 associated with at least one comorbidity * Age ≥ 18 and less than or equal to 65 years * Written informed consent obtained Exclusion Criteria: Contraindications to bariatric surgery: * severe psychiatric illness in the decompensation phase; * drug or alcohol abuse; * patient unwilling to follow periodic checkups and a dietary regimen pregnancy or lactation. Factors that could alter ADH/copeptin: * Obesity induced by other endocrinopathies or medications; * Diabetes mellitus of any type; * Malignant neoplasms or ongoing acute disease; * Organ failure or chronic CNS and kidney disease; * Hydro-electrolyte alterations; * use of drugs that interfere with pituitary-adrenal axis, diuretics, anti-psychotics and psychopharmacological therapies, GLP1 receptor agonists, estro-progestin therapy.
Where this trial is running
Bologna, Bologna
- IRCCS Azienda Ospedaliero-Universitaria di Bologna — Bologna, Bologna, Italy (Recruiting)
Study contacts
- Principal investigator: Uberto Pagotto, MD — IRCCS Azienda Ospedaliero-Universitaria di Bologna
- Study coordinator: Uberto Pagotto, MD
- Email: uberto.pagotto@unibo.it
- Phone: +390512144190
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.