ObesityNCT06806787
Copeptin and Thirst: Possible Predictive Markers of Effectiveness of Bariatric Surgery?
An observational study of Obesity, run by IRCCS Azienda Ospedaliero-Universitaria di Bologna at 1 site in Italy.
Trial summary
Prospective, non-pharmacological, spontaneous, single-center, interventional study. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Obesity
- How many people
- 30 participants
- Where
- 1 siteItaly
- Study dates
- 13 Sep 2023to 14 Mar 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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).
Who may be able to join
- 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
Who cannot join
- 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;
Show all 11Show fewer
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Bologna, Bologna, 40138
About this study
Prospective, non-pharmacological, spontaneous, single-center, interventional study.
Read the 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).
- Conditions
- Obesity
- Medical subject headings
- Obesity
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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
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.
Measured: 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.
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2025
- Study start13 Sep 2023
- Primary completion13 Mar 2026 (estimated)
- Study completion14 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by IRCCS Azienda Ospedaliero-Universitaria di BolognaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Uberto Pagotto, MD, Principal investigator, IRCCS Azienda Ospedaliero-Universitaria di Bologna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06806787
- Sponsor's protocol ID
- COPTBAR
- Status last verified
- Dec 2024
- First submitted
- 30 Dec 2024
- Last updated
- 4 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Copeptin and Thirst: Possible Predictive Markers of Effectiveness of Bariatric Surgery?
- ClinicalTrials.gov ID
- NCT06806787
- Acronym / sponsor ID
- COPTBAR
- Conditions
- Obesity
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- IRCCS Azienda Ospedaliero-Universitaria di BolognaUniversity, hospital or other
- Study start
- 13 Sep 2023 (actual)
- Primary completion
- 13 Mar 2026 (estimated)
- Study completion
- 14 Mar 2026 (estimated)
- First posted
- 4 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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).
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (11 listed)
- severe psychiatric illness in the decompensation phase;
- drug or alcohol abuse;
- patient unwilling to follow periodic checkups and a dietary regimen pregnancy or lactation.
- Obesity induced by other endocrinopathies or medications;
- Diabetes mellitus of any type;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
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.
2 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Uberto Pagotto, MD principal investigator
IRCCS Azienda Ospedaliero-Universitaria di Bologna
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obesity, run by IRCCS Azienda Ospedaliero-Universitaria di Bologna at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Uberto Pagotto, MD (+390512144190, uberto.pagotto@unibo.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative Weight Loss and Copeptin Concentration Association (time frame: through study completion, an average of 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Feb 2025.