the Change in Carotid Intima-media Thickness After Laparoscopic Sleeve Gastrectomy

March 16, 2025 updated by: Muhammed Taha Demirpolat, Umraniye Education and Research Hospital

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

65

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
    • Umraniye
      • Istanbul, Umraniye, Turkey, 34764
        • Muhammed Taha Demirpolat

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 18-65 years old,
  • BMI > 35 kg/m2
  • Laparoscopic sleeve gastrectomy will be performed
  • patients with cardiac disease

Exclusion Criteria:

  • patients without cardiac disease
  • patients who performed other bariatric surgery procedures

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: laparoscopic sleeve gastrectomy
Other: surgery
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
From enrollment to the end of the first year after laparoscopic sleeve gastrectomy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Umraniye Education and Research Hospital

Investigators

  • Study Director: Muhammed Taha Demirpolat, Assoc. Prof., University of Health Sciences Umraniye Training and Research Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2024

Primary Completion (Actual)

April 1, 2024

Study Completion (Actual)

March 1, 2025

Study Registration Dates

First Submitted

March 5, 2025

First Submitted That Met QC Criteria

March 16, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

March 16, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Carotis intima-media thickness

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

The investigators can share the results of statistical analysis

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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