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

NCT03206905 | Completed DMC

• 1 other identifier: 1501015803
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Endoscopic Sleeve Gastroplasty

EXPERIMENTAL

Procedure: Endoscopic Sleeve Gastroplasty; Behavioral: Diet and Exercise

Diet and exercise only.

ACTIVE COMPARATOR

Behavioral: Diet and Exercise

Interventions

Endoscopic Sleeve Gastroplasty PROCEDURE

endoscopic, rather than surgical approach, to perform sleeve gastroplasty

Endoscopic Sleeve Gastroplasty

Diet and Exercise BEHAVIORAL

nutritional/exercise counseling

Diet and exercise only.; Endoscopic Sleeve Gastroplasty

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Weill Medical College of Cornell University: lead

Study Sites (1)

Weill Cornell Medicine, Division of Gastroenterology & Hepatology

New York, New York, 10065, United States

Location

MeSH Terms

Conditions

Obesity

Interventions

Diet; Exercise

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Reem Sharaiha, MD

  Assistant Professor of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 29, 2017
• First Posted: July 2, 2017
• Study Start: July 1, 2017
• Primary Completion: December 31, 2018
• Study Completion: December 31, 2018
• Last Updated: April 15, 2022

Record last verified: 2022-04

Locations

US (1)