Clinical trial NCT06806787: Copeptin and Thirst: Possible Predictive Markers of Effectiveness of Bariatric Surgery?
Official title: Copeptin and Thirst: Possible Predictive Markers of Effectiveness of Bariatric Surgery?
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Obesity
Lead sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna
Sponsor class: OTHER
First posted: 2025-02-04
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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).

Brief summary: Prospective, non-pharmacological, spontaneous, single-center, interventional study.

Detailed 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 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.

Primary outcomes:
measure: Postoperative Weight Loss and Copeptin Concentration Association
timeFrame: through study completion, an average of 1 year
measure: Correlation Between Copeptin Concentration and Thirst Perception
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
measure: Association Between Reduced Copeptin Concentration and Metabolic Parameters (Fasting Glucose, Insulin, HOMA-IR, Lipid Profile, HbA1c) in Patients Undergoing Laparoscopic Sleeve Gastrectomy
timeFrame: through study completion, an average of 1 year
measure: Correlation Between Thirst Perception (Assessed by a Validated Scale) and Metabolic Parameters (Fasting Glucose, Insulin, HOMA-IR, Lipid Profile, HbA1c) in Patients Undergoing Laparoscopic Sleeve Gastrectomy
timeFrame: through study completion, an average of 1 year
Other outcomes:
Locations:
city: Bologna
country: Italy
facility: IRCCS Azienda Ospedaliero-Universitaria di Bologna
Study officials:
affiliation: IRCCS Azienda Ospedaliero-Universitaria di Bologna
name: Uberto Pagotto, MD
role: PRINCIPAL_INVESTIGATOR
References: