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

Sponsor

Weill Medical College of Cornell University (Other)

Overall Status

Completed

CT.gov ID

NCT03206905

Collaborator

(none)

Enrollment

Location

Arms

Actual Duration (Months)

0.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Obesity	Procedure: Endoscopic Sleeve Gastroplasty Behavioral: Diet and Exercise	N/A

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

2 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Safety, Tolerability and Sustained Weight Loss of Immediate Endoscopic Sleeve Gastroplasty (ESG) With Diet Modification and Exercise vs. Early Diet Modification and Exercise and Delayed ESG for the Treatment of Obesity

Actual Study Start Date :

Jul 1, 2017

Actual Primary Completion Date :

Dec 31, 2018

Actual Study Completion Date :

Dec 31, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Endoscopic Sleeve Gastroplasty	Procedure: Endoscopic Sleeve Gastroplasty endoscopic, rather than surgical approach, to perform sleeve gastroplasty Behavioral: Diet and Exercise nutritional/exercise counseling
Active Comparator: Diet and exercise only.	Behavioral: Diet and Exercise nutritional/exercise counseling

Arm

Intervention/Treatment

Experimental: Endoscopic Sleeve Gastroplasty

Procedure: Endoscopic Sleeve Gastroplasty

endoscopic, rather than surgical approach, to perform sleeve gastroplasty

Behavioral: Diet and Exercise

nutritional/exercise counseling

Active Comparator: Diet and exercise only.

Behavioral: Diet and Exercise

nutritional/exercise counseling

Outcome Measures

Primary Outcome Measures

Mean Percentage of Total Body Weight Loss [6 months]
To compare mean percentage weight loss achieved via ESG with diet modification and exercise, vs. diet modification and exercise only in patients who cannot undergo conventional bariatric surgery for obesity (with 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).

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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:

Sleep apnea (STOP-BANG questionnaire and polysomnography)
BP >130/80 or on hypertension meds.
A1c > or = to 5.7, fasting >100 OR RANDOM >126, exclude 6.5 and above
Waist circumference >102, or 40 inches if male or >80 cm 35 inches if female
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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Weill Cornell Medicine, Division of Gastroenterology & Hepatology	New York	New York	United States	10065

Sponsors and Collaborators

Weill Medical College of Cornell University

Investigators

Principal Investigator: Reem Sharaiha, MD, Assistant Professor of Medicine

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Weill Medical College of Cornell University

ClinicalTrials.gov Identifier:

NCT03206905

Other Study ID Numbers:

1501015803

First Posted:

Jul 2, 2017

Last Update Posted:

Apr 15, 2022

Last Verified:

Apr 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Obesity

Weight Loss

Study Results

No Results Posted as of Apr 15, 2022