Copeptin and Thirst: Possible Predictive Markers of Effectiveness of Bariatric Surgery?

Recruiting

• Conditions: Obesity

• Registration Number: NCT06806787
• Lead Sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna

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).

Study Timeline

• Study Start: 2023-09-13
• Status Verified: 2024-12
• Study First Submitted: 2024-12-30
• Study First Submitted QC: 2025-01-28
• Last Update Submitted: 2025-01-28
• Study First Posted: 2025-02-04
• Last Update Posted: 2025-02-04
• Primary Completion: 2026-03-13
• Study Completion: 2026-03-14

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Postoperative Weight Loss and Copeptin Concentration Association	through study completion, an average of 1 year	To verify the existence of an association between postoperative weight loss and reduced copeptin concentration in patients with obesity undergoing laparoscopic sleeve gastrectomy surgery.
Correlation Between Copeptin Concentration and Thirst Perception	through study completion, an average of 1 year	To verify the degree of correlation between copeptin concentration and thirst perception in patients with obesity undergoing laparoscopic sleeve gastrectomy surgery.

Secondary Outcome Measures

Name	Time	Method
Association Between Reduced Copeptin Concentration and Metabolic Parameters (Fasting Glucose, Insulin, HOMA-IR, Lipid Profile, HbA1c) in Patients Undergoing Laparoscopic Sleeve Gastrectomy	through study completion, an average of 1 year	To verify, in patients with obesity undergoing laparoscopic sleeve gastrectomy surgery, the existence of an association between reduced copeptin concentration and improved metabolic parameters, assessed through fasting glucose, insulin levels, HOMA-IR index, lipid profile, and HbA1c measurements.
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	through study completion, an average of 1 year	To verify, in the same patients, the degree of correlation between thirst perception, evaluated using a validated thirst perception scale, and improvement of metabolic parameters, assessed through fasting glucose, insulin levels, HOMA-IR index, lipid profile, and HbA1c measurements.

Trial Locations

Locations (1)

IRCCS Azienda Ospedaliero-Universitaria di Bologna; 🇮🇹 Bologna, Italy