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

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

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.

Study Overview

• Status: Completed
• Conditions: Obesity
• Intervention / Treatment: Procedure: Endoscopic Sleeve Gastroplasty; Behavioral: Diet and Exercise

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 Type: Interventional
• Enrollment (Actual): 2
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10065
      • Weill Cornell Medicine, Division of Gastroenterology & Hepatology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean Percentage of Total Body Weight Loss	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).	6 months

Collaborators and Investigators

• Sponsor: Weill Medical College of Cornell University
• Investigators: Principal Investigator: Reem Sharaiha, MD, Assistant Professor of Medicine

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2017
• Primary Completion (Actual): December 31, 2018
• Study Completion (Actual): December 31, 2018

Study Registration Dates

• First Submitted: June 29, 2017
• First Submitted That Met QC Criteria: June 29, 2017
• First Posted (Actual): July 2, 2017

Study Record Updates

• Last Update Posted (Actual): April 15, 2022
• Last Update Submitted That Met QC Criteria: April 14, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Overweight; Body Weight; Body Weight Changes; Obesity; Weight Loss
• Other Study ID Numbers: 1501015803

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No