Safety, Tolerability, and Sustained Weight Loss of Endoscopic Sleeve Gastroplasty With Diet Modification and Exercise

NCT ID: NCT03206905

Last Updated: 2022-04-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 2 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-07-01
• Study Completion Date: 2018-12-31

Brief Summary

The purpose of this study is to compare the effect of endoscopic sleeve gastroplasty (ESG) with diet and exercise, to diet and exercise alone, to see which is better in weight loss reduction. Investigators will also compare the effects of ESG to diet and exercise comorbidities such as diabetes, sleep apnea and high cholesterol as well as the various obesity related hormones.

Detailed Description

This is a single center, prospective randomized case control study with an additional non randomized case arm. This study includes two research interventional groups. Groups A: ESG with diet and exercise modules. Group B: Diet and exercise modules only. Investigators propose to compare ESG to behavioral modification including diet and exercise for patients who have a BMI greater than or equal to 40 kg/m2 or greater than or equal to 30 kg/m2 with 1 or more obesity related co-morbidity and who cannot undergo conventional bariatric surgery(or decline the surgical option). Investigators will also compare the effects of ESG to diet and exercise on comorbidities such as diabetes, sleep apnea and high cholesterol as well as the various obesity related hormones.

Conditions

Obesity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Endoscopic Sleeve Gastroplasty

Group Type: EXPERIMENTAL

Endoscopic Sleeve Gastroplasty

Intervention Type: PROCEDURE

endoscopic, rather than surgical approach, to perform sleeve gastroplasty

Diet and Exercise

Intervention Type: BEHAVIORAL

nutritional/exercise counseling

Diet and exercise only.

Group Type: ACTIVE_COMPARATOR

Diet and Exercise

Intervention Type: BEHAVIORAL

nutritional/exercise counseling

Interventions

Endoscopic Sleeve Gastroplasty

endoscopic, rather than surgical approach, to perform sleeve gastroplasty

Intervention Type: PROCEDURE

Diet and Exercise

nutritional/exercise counseling

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• BMI greater than or equal to 40 kg/m2, greater than or equal to to 30 kg/m2 with 1 more obesity related co-morbidity, or or greater than or equal to 35 kg/m2 without co-morbidity

Co-morbidities include:

1. Sleep apnea (STOP-BANG questionnaire and polysomnography)

2. BP >130/80 or on hypertension meds.

3. A1c > or = to 5.7, fasting >100 OR RANDOM >126, exclude 6.5 and above

4. Waist circumference >102, or 40 inches if male or >80 cm 35 inches if female

5. Metabolic syndrome (3 criteria, blood pressure, waist circumference, triglycerides > 150 or HDL < 50/40)

• Failure to respond to non-invasive weight loss management for at least 6 months.
• Valid health insurance to cover the cost of procedure and standard of care pre-and post-procedure management/workup.

Exclusion Criteria

• Untreated endocrine diseases (diabetes, thyroid disorder, pituitary disorder, and sex gland disorder).
• diabetes or A1c >6.5
• Heart Disease, for example, arrhythmia, heart failure, myocardial infarction.
• Kidney disease with serum creatinine greater than 2.5 mg/dl.
• Cerebrovascular disease, for example, stroke or otherwise unable to exercise.
• Any pregnant or lactating women or who have had childbirth within 6 months.
• Any patients on retinoid therapy or undergoing retinoid therapy that will not last throughout the length of the trial.
• Patients with significant psychiatric disorder.
• Any other chronic condition deemed unsuitable to undergo either arm of the trial.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Weill Medical College of Cornell University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Reem Sharaiha, MD

Role: PRINCIPAL_INVESTIGATOR

Assistant Professor of Medicine

Locations

Weill Cornell Medicine, Division of Gastroenterology & Hepatology

New York, New York, United States

Countries

United States

Other Identifiers

1501015803

Identifier Type: -

Identifier Source: org_study_id