Copeptin and Thirst: Possible Predictive Markers of Effectiveness of Bariatric Surgery?
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Obesity. Basic parameters: 18 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Italy
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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).
Primary outcome measures
- Postoperative Weight Loss and Copeptin Concentration Association [Time frame: through study completion, an average of 1 year]
- Correlation Between Copeptin Concentration and Thirst Perception [Time frame: through study completion, an average of 1 year]
Secondary outcome measures (2)
- 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]
- 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]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Case-control
Study locations
Italy · 1 center
- IRCCS Azienda Ospedaliero-Universitaria di Bologna — Bologna
Identifiers
NCT: NCT06806787 · COPTBAR