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Recruiting

NCT Number: NCT06806787

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

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

Recruiting

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Bologna, 40138, Italy

Location status: Recruiting

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Postoperative Weight Loss and Copeptin Concentration Association

    Time frame: 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.

  2. Correlation Between Copeptin Concentration and Thirst Perception

    Time frame: 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 outcomes

  1. Association Between Reduced Copeptin Concentration and Metabolic Parameters (Fasting Glucose, Insulin, HOMA-IR, Lipid Profile, HbA1c) in Patients Undergoing Laparoscopic Sleeve Gastrectomy

    Time frame: 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.

  2. 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

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Uberto Pagotto, MD

CONTACT

[email protected]

+390512144190

Sponsors and collaborators

Lead sponsor

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Other

Registry information

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Feb 4, 2025
Registry last updated
Feb 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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