Mechanism of Weight Loss After Endoscopic and Laparoscopic Sleeve Procedures

Northwell Health

Status: Terminated

Conditions: Weight Loss; Reflux

Treatments: Other: Metabolic and Hormonal profile

Study type: Observational

Funder types: Other

Identifiers

NCT04006002

19-0112

Details and patient eligibility

About

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.

Full 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.

Enrollment: 4 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

4 participants in 2 patient groups

Endoscopic Sleeve Gastrectomy

Description:

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

Treatment:

Other: Metabolic and Hormonal profile

Laproscopic Sleeve Gastrectomy

Description:

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

Treatment:

Other: Metabolic and Hormonal profile