Overview
Prospective, non-pharmacological, spontaneous, single-center, interventional study.
Description
COPTBAR is a prospective, nonpharmacological spontaneous single-center interventional study.
Laboratory tests and imaging study (complete abdomen ultrasonography) for monitoring patients will be conducted in accordance with normal clinical practice. In addition, periodic copeptin assay will be performed. Each patient, within the study protocol, will be evaluated for 12 months; thereafter, each patient will fall under the follow-up visits provided by normal clinical practice and by Corporate Diagnostic Therapeutic Pathway (PDTA).
Eligibility
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.