ObesityNCT03206905
Safety, Tolerability, and Sustained Weight Loss of Endoscopic Sleeve Gastroplasty With Diet Modification and Exercise
A study testing Endoscopic Sleeve Gastroplasty and Diet and Exercise in people with Obesity, run by Weill Medical College of Cornell University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Obesity
- What is being tested?
- Endoscopic Sleeve Gastroplasty and Diet and Exercise
- Type of treatment
- Surgery or procedure, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2017to 31 Dec 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Weill Cornell Medicine, Division of Gastroenterology & Hepatology
New York, New York, 10065
About this study
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
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.
Read the 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
- Being tested
- Endoscopic Sleeve Gastroplasty, Diet and Exercise
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endoscopic Sleeve GastroplastyProcedure or surgery
endoscopic, rather than surgical approach, to perform sleeve gastroplasty
Diet and ExerciseBehavioural
nutritional/exercise counseling
| Study group | Role | What they receive |
|---|---|---|
| Endoscopic Sleeve Gastroplasty | Experimental | Not described Receives: Procedure: Endoscopic Sleeve Gastroplasty; Behavioral: Diet and Exercise |
| Diet and exercise only. | Active comparator | Not described Receives: Behavioral: Diet and Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2017
- Study start1 Jul 2017
- Primary completion31 Dec 2018
- Study completion31 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by Weill Medical College of Cornell UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Weill Medical College of Cornell University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Reem Sharaiha, MD, Principal investigator, Assistant Professor of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03206905
- Sponsor's protocol ID
- 1501015803
- Status last verified
- Apr 2022
- First submitted
- 29 Jun 2017
- Last updated
- 15 Apr 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03206905
- Acronym / sponsor ID
- 1501015803
- Conditions
- Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Weill Medical College of Cornell UniversityUniversity, hospital or other
- Study start
- 1 Jul 2017 (actual)
- Primary completion
- 31 Dec 2018 (actual)
- Study completion
- 31 Dec 2018 (actual)
- First posted
- 2 Jul 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Endoscopic Sleeve Gastroplasty | Experimental | Procedure: Endoscopic Sleeve Gastroplasty, Behavioral: Diet and Exercise |
| Diet and exercise only. | Active comparator | Behavioral: Diet and Exercise |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
- 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
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Endoscopic Sleeve Gastroplastyendoscopic, rather than surgical approach, to perform sleeve gastroplasty | Procedure or surgery | Endoscopic Sleeve Gastroplasty |
| Diet and Exercisenutritional/exercise counseling | Behavioural | Diet and exercise only., Endoscopic Sleeve Gastroplasty |
Primary outcome
Mean Percentage of Total Body Weight Loss
Time frame: 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).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2022.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Reem Sharaiha, MD principal investigator
Assistant Professor of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Endoscopic Sleeve Gastroplasty and Diet and Exercise in people with Obesity, run by Weill Medical College of Cornell University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean Percentage of Total Body Weight Loss (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Apr 2022.