Mechanism of Weight Loss After Endoscopic and Laparoscopic Sleeve Procedures

NCT04006002 | Terminated

• 1 other identifier: 19-0112
• Study Type: observational
• Target: 4
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Weight Loss; Reflux

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Compare gastric emptying after intervention

  1 year

Study Arms (2)

Endoscopic Sleeve Gastrectomy

This group includes all patient who undergo Endoscopic Sleeve Gastrectomy for weight loss

Other: Metabolic and Hormonal profile

Laproscopic Sleeve Gastrectomy

This group includes all patient who undergo Laproscopic Sleeve Gastrectomy for weight loss

Other: Metabolic and Hormonal profile

Interventions

Metabolic and Hormonal profile OTHER

To assess changes in metabolic profiles and body metrics such as weight and BMI in these patients after an endoscopic or surgical bariatric intervention

Endoscopic Sleeve Gastrectomy; Laproscopic Sleeve Gastrectomy

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• BMI ≥ 30 Kg/m2 scheduled to undergo a bariatric intervention
• Patients who will be undergoing ESG or LSG as part of their clinical care Age between 18 and 75 years.
• Both male and female subjects will be included in the study.
• Subjects from any ethnic background will be included in the study.
• 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).
• Successfully complete the screening process.
• Patients able to provide written informed consent on the IRB/EC-approved informed consent form.
• Demonstrate willingness to follow protocol requirements, including follow-up schedule, and completion of questionnaires.
• Having standard of care therapy (endoscopic or laproscopic) for treatment of Obesity.

You may not qualify if:

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

Sponsors & Collaborators

• Northwell Health: lead

Study Sites (1)

Northwell Health

New York, New York, 10014, United States

Location

Related Publications (3)

• 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.

  PMID: 27989851 BACKGROUND

• 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.

  PMID: 29110192 BACKGROUND

• 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.

  PMID: 18355825 BACKGROUND

MeSH Terms

Conditions

Weight Loss; Gastroesophageal Reflux

Interventions

Metabolic Networks and Pathways

Condition Hierarchy (Ancestors)

Body Weight Changes; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Metabolism

Study Officials

• Petros Benias, MD

  Northwell Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 7, 2019
• First Posted: July 2, 2019
• Study Start: July 1, 2019
• Primary Completion: June 30, 2021
• Study Completion: January 28, 2022
• Last Updated: February 14, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)