Laparoscopic Sleeve GastrectomyNCT04439851
Impact of Sleeve Gastrectomy on Monocyte-to-High-Density Lipoprotein Cholesterol Ratio
An observational study of Laparoscopic Sleeve Gastrectomy and Cardiovascular Risk Factor, run by Umraniye Education and Research Hospital.
Trial summary
The present study hypothesized that significant weight loss is associated with a reduction in the inflammatory markers, leading to diminished cardiovascular risks in patients undergoing laparoscopic sleeve gastrectomy (LGS). We found a decrease in MHR at postoperative 6 months from baseline in patients undergoing LSG. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Laparoscopic Sleeve Gastrectomy, Cardiovascular Risk Factor, Obesity
- How many people
- 125 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2017to 31 Dec 2017
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Obese patients (BMI ≥40 or >35+ and accompanying DM, HT and hyperlipidemia)
Who may be able to join
- Obese patients (BMI ≥40 or >35+ and accompanying DM, HT and hyperlipidemia) Underwent laparoscopic sleeve gastrectomy.
Who cannot join
- Receiving antihyperlipidemic therapy, Important complications that continue within 6 months after surgery (anastomotic leaks, pulmonary embolism, deep vein thrombosis, soft tissue infection) Did not attend 6-month control visit were excluded from the study.
About this study
Official title: The Relationship Between Monocyte-to-High-Density Lipoprotein Cholesterol Ratio, Metabolic Parameters and Excess Weight Loss in Patients Undergoing Laparoscopic Sleeve Gastrectomy
The present study hypothesized that significant weight loss is associated with a reduction in the inflammatory markers, leading to diminished cardiovascular risks in patients undergoing laparoscopic sleeve gastrectomy (LGS).
We found a decrease in MHR at postoperative 6 months from baseline in patients undergoing LSG. The decrease in MHR was more remarkable with increasing percentage of EWL, but no relationship between the %EWL and MHR.
Read the detailed description
The present study aims to evaluate the relationship between MHR, metabolic parameters and the percentage of excess weight loss (%EWL) in participants undergoing laparoscopic sleeve gastrectomy (LSG).
This prospective cohort study will evaluate obese participants undergoing LSG. Demographic data of the participants and blood glucose level, monocyte count and lipid parameters baseline and at 6 months after surgery will record. The MHR baseline and at 6 months after surgery and the %EWL at 6 months after surgery will calculate. The participants will be divide into two groups as participants with %EWL of <50 and patients with a %EWL of ≥50. The parameters will compare between the two groups.
- Medical subject headings
- Obesity
What is being measured
The primary outcome is the main question the study is designed to answer.
Monocyte-to-High-Density Lipoprotein Cholesterol Ratio changes
Monocyte-to-High-Density Lipoprotein Cholesterol Ratio changes after Sleeve Gastrectomy
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2020
- Study start1 Jan 2017
- Primary completion31 Dec 2017
- Study completion31 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Laparoscopic Sleeve GastrectomyStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 125 participants (actual)
Sponsor and investigators
- Lead sponsor
- Umraniye Education and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Sibel Ocak Serin, Umraniye Education and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04439851
- Sponsor's protocol ID
- umraniye training hospital
- Status last verified
- Jun 2020
- First submitted
- 10 Jun 2020
- Last updated
- 19 Jun 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Relationship Between Monocyte-to-High-Density Lipoprotein Cholesterol Ratio, Metabolic Parameters and Excess Weight Loss in Patients Undergoing Laparoscopic Sleeve Gastrectomy
- ClinicalTrials.gov ID
- NCT04439851
- Acronym / sponsor ID
- umraniye training hospital
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 125 participants (actual)
- Lead sponsor
- Umraniye Education and Research HospitalOther government
- Study start
- 1 Jan 2017 (actual)
- Primary completion
- 31 Dec 2017 (actual)
- Study completion
- 31 Dec 2017 (actual)
- First posted
- 19 Jun 2020 (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 present study hypothesized that significant weight loss is associated with a reduction in the inflammatory markers, leading to diminished cardiovascular risks in patients undergoing laparoscopic sleeve gastrectomy (LGS).
We found a decrease in MHR at postoperative 6 months from baseline in patients undergoing LSG. The decrease in MHR was more remarkable with increasing percentage of EWL, but no relationship between the %EWL and MHR.
Detailed description
The present study aims to evaluate the relationship between MHR, metabolic parameters and the percentage of excess weight loss (%EWL) in participants undergoing laparoscopic sleeve gastrectomy (LSG).
This prospective cohort study will evaluate obese participants undergoing LSG. Demographic data of the participants and blood glucose level, monocyte count and lipid parameters baseline and at 6 months after surgery will record. The MHR baseline and at 6 months after surgery and the %EWL at 6 months after surgery will calculate. The participants will be divide into two groups as participants with %EWL of <50 and patients with a %EWL of ≥50. The parameters will compare between the two groups.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Obese patients (BMI ≥40 or >35+ and accompanying DM, HT and hyperlipidemia)
Key inclusion criteria (1 listed)
- Obese patients (BMI ≥40 or >35+ and accompanying DM, HT and hyperlipidemia) Underwent laparoscopic sleeve gastrectomy.
Key exclusion criteria (1 listed)
- Receiving antihyperlipidemic therapy, Important complications that continue within 6 months after surgery (anastomotic leaks, pulmonary embolism, deep vein thrombosis, soft tissue infection) Did not attend 6-month control visit were excluded from the study.
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
Monocyte-to-High-Density Lipoprotein Cholesterol Ratio changes
Time frame: 6 months
Monocyte-to-High-Density Lipoprotein Cholesterol Ratio changes after Sleeve Gastrectomy
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 19 Jun 2020.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Laparoscopic Sleeve Gastrectomy and Cardiovascular Risk Factor, run by Umraniye Education and Research Hospital.
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 1 inclusion and 1 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 19 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
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?
Monocyte-to-High-Density Lipoprotein Cholesterol Ratio changes (time frame: 6 months). 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 19 Jun 2020.