Mechanism of Weight Loss After Endoscopic and Laparoscopic Sleeve Procedures

A Pilot Study to Compare Anatomic, Physiologic, Metabolic and Weight Changes After Standard of Care Endoscopic Gastric Restrictive Bariatric Interventions vs. Standard of Care Laparoscopic Sleeve Gastrectomy

The purpose of this research study is to understand the mechanism of weight loss for weight loss procedures: that is Laparoscopic sleeve gastrectomy and Endoscopic sleeve Gastroplasty.

Study Overview

• Status: Terminated
• Conditions: Weight Loss; Reflux
• Intervention / Treatment: Other: Metabolic and Hormonal profile

Detailed Description

We want to better understand the mechanisms for weight loss by understanding the anatomic and physiologic changes that occur with gastric restrictive procedures for weight loss and to determine the differences in metabolic profile between the two restrictive procedures. We also want to identify the rate of Gastro Esophageal Reflux Disease (GERD) in patients undergoing gastric restrictive procedures for weight loss.

• Study Type: Observational
• Enrollment (Actual): 4

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10014
      • Northwell Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Only participants who meet all eligibility criteria will be enrolled in the study. Participants who meet all eligibility criteria and have successfully completed the screening requirements will be asked to sign a Study Consent.

Patients undergoing endoscopic or laparoscopic weight loss procedures will be included.

Description

Inclusion Criteria:

1. BMI ≥ 30 Kg/m2 scheduled to undergo a bariatric intervention
2. Patients who will be undergoing ESG or LSG as part of their clinical care Age between 18 and 75 years.
3. Both male and female subjects will be included in the study.
4. Subjects from any ethnic background will be included in the study.
5. Female participants of childbearing age should not be pregnant. (Pregnancy test will be performed on all women of child bearing potential before any standard of care endoscopic procedure. For the purpose of the study we will record that information in the patient study records).
6. Successfully complete the screening process.
7. Patients able to provide written informed consent on the IRB/EC-approved informed consent form.
8. Demonstrate willingness to follow protocol requirements, including follow-up schedule, and completion of questionnaires.
9. Having standard of care therapy (endoscopic or laproscopic) for treatment of Obesity.

Exclusion Criteria:

1. Pregnant or planning to become pregnant during period of study participation.
2. Female participants who are breast-feeding.
3. Severe Immunodeficiency.
4. Severe malnutrition.
5. The participant has life expectancy of less than 1 year due to other medical conditions.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Endoscopic Sleeve Gastrectomy; This group includes all patient who undergo Endoscopic Sleeve Gastrectomy for weight loss	Other: Metabolic and Hormonal profile; To assess changes in metabolic profiles and body metrics such as weight and BMI in these patients after an endoscopic or surgical bariatric intervention
Laproscopic Sleeve Gastrectomy; This group includes all patient who undergo Laproscopic Sleeve Gastrectomy for weight loss	Other: Metabolic and Hormonal profile; To assess changes in metabolic profiles and body metrics such as weight and BMI in these patients after an endoscopic or surgical bariatric intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of participants with GERD before and after intervention	Percentage of participants with GERD (>6% abnormal esophageal acid exposure calculated via BRAVO pH monitoring for 96 hrs ) before and at 12 months after an endoscopic or surgical bariatric intervention	1 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Compare gastric emptying after intervention	To compare gastric emptying and small bowel transit times, before and at 12 months after an endoscopic or surgical bariatric intervention using wireless capsule technology	1 year

Collaborators and Investigators

• Sponsor: Northwell Health
• Investigators: Principal Investigator: Petros Benias, MD, Northwell Health

Publications and helpful links

General Publications

• Jirapinyo P, Thompson CC. Endoscopic Bariatric and Metabolic Therapies: Surgical Analogues and Mechanisms of Action. Clin Gastroenterol Hepatol. 2017 May;15(5):619-630. doi: 10.1016/j.cgh.2016.10.021. Epub 2016 Oct 28.
• Novikov AA, Afaneh C, Saumoy M, Parra V, Shukla A, Dakin GF, Pomp A, Dawod E, Shah S, Aronne LJ, Sharaiha RZ. Endoscopic Sleeve Gastroplasty, Laparoscopic Sleeve Gastrectomy, and Laparoscopic Band for Weight Loss: How Do They Compare? J Gastrointest Surg. 2018 Feb;22(2):267-273. doi: 10.1007/s11605-017-3615-7. Epub 2017 Nov 6.
• Fogel R, De Fogel J, Bonilla Y, De La Fuente R. Clinical experience of transoral suturing for an endoluminal vertical gastroplasty: 1-year follow-up in 64 patients. Gastrointest Endosc. 2008 Jul;68(1):51-8. doi: 10.1016/j.gie.2007.10.061. Epub 2008 Mar 19.

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2019
• Primary Completion (Actual): June 30, 2021
• Study Completion (Actual): January 28, 2022

Study Registration Dates

• First Submitted: June 7, 2019
• First Submitted That Met QC Criteria: July 1, 2019
• First Posted (Actual): July 2, 2019

Study Record Updates

• Last Update Posted (Actual): February 14, 2022
• Last Update Submitted That Met QC Criteria: January 28, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Body Weight Changes; Weight Loss; Body Weight
• Other Study ID Numbers: 19-0112

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No