Back to resultsSafety, Tolerability, and Sustained Weight Loss of Endoscopic Sleeve Gastroplasty With Diet Modification and Exercise
Primary Purpose
Obesity
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Endoscopic Sleeve Gastroplasty
Diet and Exercise
Sponsored by
About this trial
This is an interventional treatment trial for Obesity
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:
- 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.
Sites / Locations
- Weill Cornell Medicine, Division of Gastroenterology & Hepatology
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Endoscopic Sleeve Gastroplasty
Diet and exercise only.
Arm Description
Outcomes
Primary Outcome Measures
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).
Secondary Outcome Measures
Full Information
NCT ID
NCT03206905
First Posted
June 29, 2017
Last Updated
April 14, 2022
Sponsor
Weill Medical College of Cornell University
1. Study Identification
Unique Protocol Identification Number
NCT03206905
Brief Title
Safety, Tolerability, and Sustained Weight Loss of Endoscopic Sleeve Gastroplasty With Diet Modification and Exercise
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
Study Type
Interventional
2. Study Status
Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
July 1, 2017 (Actual)
Primary Completion Date
December 31, 2018 (Actual)
Study Completion Date
December 31, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Weill Medical College of Cornell University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
2 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Endoscopic Sleeve Gastroplasty
Arm Type
Experimental
Arm Title
Diet and exercise only.
Arm Type
Active Comparator
Intervention Type
Procedure
Intervention Name(s)
Endoscopic Sleeve Gastroplasty
Intervention Description
endoscopic, rather than surgical approach, to perform sleeve gastroplasty
Intervention Type
Behavioral
Intervention Name(s)
Diet and Exercise
Intervention Description
nutritional/exercise counseling
Primary Outcome Measure Information:
Title
Mean Percentage of Total Body Weight Loss
Description
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).
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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:
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Reem Sharaiha, MD
Organizational Affiliation
Assistant Professor of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Weill Cornell Medicine, Division of Gastroenterology & Hepatology
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Safety, Tolerability, and Sustained Weight Loss of Endoscopic Sleeve Gastroplasty With Diet Modification and Exercise
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