Mechanism of Weight Loss After Endoscopic and Laparoscopic Sleeve Procedures

Terminated

• Conditions: Reflux; Weight Loss
• Interventions: Other: Metabolic and Hormonal profile

• Registration Number: NCT04006002
• Lead Sponsor: Northwell Health

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.

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 Timeline

• Study First Submitted: 2019-06-07
• Study Start: 2019-07-01
• Study First Submitted QC: 2019-07-01
• Study First Posted: 2019-07-02
• Primary Completion: 2021-06-30
• Status Verified: 2022-01
• Study Completion: 2022-01-28
• Last Update Submitted: 2022-01-28
• Last Update Posted: 2022-02-14

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 4

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Laproscopic Sleeve Gastrectomy	Metabolic and Hormonal profile	This group includes all patient who undergo Laproscopic Sleeve Gastrectomy for weight loss
Endoscopic Sleeve Gastrectomy	Metabolic and Hormonal profile	This group includes all patient who undergo Endoscopic Sleeve Gastrectomy for weight loss

Primary Outcome Measures

Name	Time	Method
Percentage of participants with GERD before and after intervention	1 years	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

Secondary Outcome Measures

Name	Time	Method
Compare gastric emptying after intervention	1 year	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

Trial Locations

Locations (1)

Northwell Health; 🇺🇸 New York, New York, United States