NCT04439851

Brief 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. The decrease in MHR was more remarkable with increasing percentage of EWL, but no relationship between the %EWL and MHR.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
125

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2017

Shorter than P25 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2017

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2017

Completed
2.4 years until next milestone

First Submitted

Initial submission to the registry

June 10, 2020

Completed
9 days until next milestone

First Posted

Study publicly available on registry

June 19, 2020

Completed
Last Updated

June 19, 2020

Status Verified

June 1, 2020

Enrollment Period

12 months

First QC Date

June 10, 2020

Last Update Submit

June 17, 2020

Conditions

Laparoscopic Sleeve GastrectomyCardiovascular Risk FactorObesity

Outcome Measures

Primary Outcomes (1)

  • Monocyte-to-High-Density Lipoprotein Cholesterol Ratio changes

    Monocyte-to-High-Density Lipoprotein Cholesterol Ratio changes after Sleeve Gastrectomy

    6 months

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Obese patients (BMI ≥40 or \>35+ and accompanying DM, HT and hyperlipidemia)

You may qualify if:

  • Obese patients (BMI ≥40 or \>35+ and accompanying DM, HT and hyperlipidemia) Underwent laparoscopic sleeve gastrectomy.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

June 10, 2020

First Posted

June 19, 2020

Study Start

January 1, 2017

Primary Completion

December 31, 2017

Study Completion

December 31, 2017

Last Updated

June 19, 2020

Record last verified: 2020-06