Weight LossNCT06882616
the Change in Carotid Intima-media Thickness After Laparoscopic Sleeve Gastrectomy
A study testing surgery in people with Weight Loss and Reduce the Risk of Cardiac Disease, run by Umraniye Education and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study was to compare carotid intima-media thicknesses in laparoscopic sleeve gastrectomy patients preoperatively and at the end of the first postoperative year. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Weight Loss, Reduce the Risk of Cardiac Disease, Carotis Intima-media Thickness
- What is being tested?
- surgery
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 65 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Mar 2024to 1 Mar 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
Who may be able to join
- 18-65 years old,
- BMI > 35 kg/m2
- Laparoscopic sleeve gastrectomy will be performed
- patients with cardiac disease
Who cannot join
- patients without cardiac disease
- patients who performed other bariatric surgery procedures
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Muhammed Taha Demirpolat
Istanbul, Umraniye, 34764
About this study
Official title: The Effect of Laparoscopic Sleeve Gastrectomy on the Change in Carotid Intima-media Thickness in Patients With Obesity: Prospective Randomized Trial
The aim of this study was to compare carotid intima-media thicknesses in laparoscopic sleeve gastrectomy patients preoperatively and at the end of the first postoperative year.
Read the detailed description
Obesity is not only a disease in itself, but also predisposes to many other diseases. Cardiac diseases are one of the systems that obesity predisposes to. Obesity has been found to increase the risk of cardiac disease by increasing carotid intima-media thickness in patients with obesity. Surgery is known to be the most effective treatment for obesity and laparoscopic sleeve gastrectomy is the most common bariatric surgery procedure. Laparoscopic sleeve gastrectomy may reduce the risk of cardiac disease by reducing carotid intima-media thickness in patients with obesity through effective weight loss.
- Being tested
- surgery
- Keywords
- Carotis intima-media thickness, Laparoscopic sleeve gastrectomy
- Medical subject headings
- Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
surgeryOther
All patients will be perform laparoscopic sleeve gastrectomy. Carotid intima-media thickness will be analyzed preoperatively and at the end of the first postoperative year.
| Study group | Role | What they receive |
|---|---|---|
| laparoscopic sleeve gastrectomy | Other | laparoscopic sleeve gastrectomy Receives: Other: surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
carotid intima-media thickness
The primary outcome of the study was to compare carotid intima-media thickness at the end of the first postoperative year after laparoscopic sleeve gastrectomy (LSG) with baseline carotid intima-media thickness in patients with obesity. The investigators will measure carotid intima-media thickness with carotid doppler ultrasound before LSG and at the end of the first year after LSG and compare the results.
Measured: From enrollment to the end of the first year after laparoscopic sleeve gastrectomy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2025
- Study start1 Mar 2024
- Primary completion1 Apr 2024
- Study completion1 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Weight LossStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Prospective, observational
- Masking
- None (open label)
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- Umraniye Education and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Muhammed Taha Demirpolat, Umraniye Education and Research Hospital
- Investigators
- Muhammed Taha Demirpolat, Assoc. Prof., Study director, University of Health Sciences Umraniye Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06882616
- Sponsor's protocol ID
- Carotis intima-media thickness
- Status last verified
- Mar 2025
- First submitted
- 5 Mar 2025
- Last updated
- 18 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The investigators can share the results of statistical analysis
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Laparoscopic Sleeve Gastrectomy on the Change in Carotid Intima-media Thickness in Patients With Obesity: Prospective Randomized Trial
- ClinicalTrials.gov ID
- NCT06882616
- Acronym / sponsor ID
- Carotis intima-media thickness
- Keywords
- Carotis intima-media thickness, Laparoscopic sleeve gastrectomy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- Umraniye Education and Research HospitalOther government
- Study start
- 1 Mar 2024 (actual)
- Primary completion
- 1 Apr 2024 (actual)
- Study completion
- 1 Mar 2025 (actual)
- First posted
- 18 Mar 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.
The aim of this study was to compare carotid intima-media thicknesses in laparoscopic sleeve gastrectomy patients preoperatively and at the end of the first postoperative year.
Detailed description
Obesity is not only a disease in itself, but also predisposes to many other diseases. Cardiac diseases are one of the systems that obesity predisposes to. Obesity has been found to increase the risk of cardiac disease by increasing carotid intima-media thickness in patients with obesity. Surgery is known to be the most effective treatment for obesity and laparoscopic sleeve gastrectomy is the most common bariatric surgery procedure. Laparoscopic sleeve gastrectomy may reduce the risk of cardiac disease by reducing carotid intima-media thickness in patients with obesity through effective weight loss.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Prospective, observational
| Arm | Type | Receives |
|---|---|---|
| laparoscopic sleeve gastrectomy | Other | Other: surgerylaparoscopic sleeve gastrectomy |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 18-65 years old,
- BMI > 35 kg/m2
- Laparoscopic sleeve gastrectomy will be performed
- patients with cardiac disease
Key exclusion criteria (2 listed)
- patients without cardiac disease
- patients who performed other bariatric surgery procedures
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| surgeryAll patients will be perform laparoscopic sleeve gastrectomy. Carotid intima-media thickness will be analyzed preoperatively and at the end of the first postoperative year. | Other | laparoscopic sleeve gastrectomy |
Primary outcome
carotid intima-media thickness
Time frame: From enrollment to the end of the first year after laparoscopic sleeve gastrectomy
The primary outcome of the study was to compare carotid intima-media thickness at the end of the first postoperative year after laparoscopic sleeve gastrectomy (LSG) with baseline carotid intima-media thickness in patients with obesity. The investigators will measure carotid intima-media thickness with carotid doppler ultrasound before LSG and at the end of the first year after LSG and compare the results.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2025.
- Individual participant dataSharing planned: No. The investigators can share the results of statistical analysis
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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. This study is not recruiting at the moment.
Muhammed Taha Demirpolat, Assoc. Prof. study director
University of Health Sciences Umraniye Training and Research Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing surgery in people with Weight Loss and Reduce the Risk of Cardiac Disease, run by Umraniye Education and Research Hospital at 1 site in Turkey (Türkiye).
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 4 inclusion and 2 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: finished, as of the sponsor's last update on 18 Mar 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 Turkey (Türkiye). 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
carotid intima-media thickness (time frame: From enrollment to the end of the first year after laparoscopic sleeve gastrectomy). 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 18 Mar 2025.