Mechanism of Weight Loss After Endoscopic and Laparoscopic Sleeve Procedures

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

4 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-07-01

Study Completion Date

2022-01-28

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Weight Loss Reflux

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Endoscopic Sleeve Gastrectomy

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

Metabolic and Hormonal profile

Intervention Type 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

Laproscopic Sleeve Gastrectomy

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

Metabolic and Hormonal profile

Intervention Type 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

Interventions

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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

Intervention Type OTHER

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes