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Prospective, non-pharmacological, spontaneous, single-center, interventional 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).
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Association Between Reduced Copeptin Concentration and Metabolic Parameters (Fasting Glucose, Insulin, HOMA-IR, Lipid Profile, HbA1c) in Patients Undergoing Laparoscopic Sleeve Gastrectomy | 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. |
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Inclusion Criteria:
Exclusion Criteria:
Contraindications to bariatric surgery:
Factors that could alter ADH/copeptin:
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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).
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Uberto Pagotto, MD | Contact | +390512144190 | uberto.pagotto@unibo.it |
| Name | Affiliation | Role |
|---|---|---|
| Uberto Pagotto, MD | IRCCS Azienda Ospedaliero-Universitaria di Bologna | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| IRCCS Azienda Ospedaliero-Universitaria di Bologna | Recruiting | Bologna | Bologna | 40138 | Italy |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| 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 | 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. | through study completion, an average of 1 year |
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |