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

NCT06806787 | Recruiting

• 1 other identifier: COPTBAR
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Prospective, non-pharmacological, spontaneous, single-center, interventional study.

Conditions

Obesity

Outcome Measures

Primary Outcomes (2)

• Postoperative Weight Loss and Copeptin Concentration Association

  To verify the existence of an association between postoperative weight loss and reduced copeptin concentration in patients with obesity undergoing laparoscopic sleeve gastrectomy surgery.

  through study completion, an average of 1 year

• Correlation Between Copeptin Concentration and Thirst Perception

  To verify the degree of correlation between copeptin concentration and thirst perception in patients with obesity undergoing laparoscopic sleeve gastrectomy surgery.

  through study completion, an average of 1 year

Secondary Outcomes (2)

• 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

• 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

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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).

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• IRCCS Azienda Ospedaliero-Universitaria di Bologna: lead

Study Sites (1)

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Bologna, Bologna, 40138, Italy

RECRUITING

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Uberto Pagotto, MD

  IRCCS Azienda Ospedaliero-Universitaria di Bologna

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Uberto Pagotto, MD

CONTACT

+390512144190; uberto.pagotto@unibo.it

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 30, 2024
• First Posted: February 4, 2025
• Study Start: September 13, 2023
• Primary Completion: March 13, 2026
• Study Completion: March 14, 2026
• Last Updated: February 4, 2025

Record last verified: 2024-12

Locations

IT (1)