Mechanism of Weight Loss After Endoscopic and Laparoscopic Sleeve Procedures

Weight Loss Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04006002
• Other study ID #: 19-0112
• Status: Terminated
• Start date: July 1, 2019
• Est. completion date: January 28, 2022

Study information

• Verified date: January 2022
• Source: Northwell Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 4
• Est. completion date: January 28, 2022
• Est. primary completion date: June 30, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Body Weight
• Reflux
• Weight Loss

Intervention

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

Locations

Country	Name	City	State
United States	Northwell Health	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Northwell Health

Country where clinical trial is conducted

United States, 

References & Publications (3)

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. — View Citation

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. Review. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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