Endoscopic management of obesity: Impact of endoscopic sleeve gastroplasty on weight loss and co-morbidities at six months and one year.
F Alexandre, A Lapergola, M Vannucci...
https://pubmed.ncbi.nlm.nih.gov/36725451Actively Recruiting
Phase Not Applicable
Age: 18Years +
All Genders
ID07082608
Impact of Weight Loss From Endoscopic Sleeve Gastropathy (ESG) Plus Lifestyle Modification Versus Lifestyle Modification Alone on Obstructive Sleep Apnea Patients With Obesity
Led by Asian Institute of Gastroenterology, India · Updated on 2025-12-19
74
Participants Needed
1
Research Sites
N/A
Total Duration
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AI-Summary
What this Trial Is About
Obstructive Sleep Apnea (OSA) is a condition where breathing repeatedly stops during sleep, often linked to obesity due to extra fat around the neck and throat. This research aims to compare whether Endoscopic Sleeve Gastroplasty (ESG), a non-surgical weight-loss procedure, combined with lifestyle changes, improves OSA symptoms better than lifestyle changes alone. The study focuses on people with obesity and moderate to severe OSA to understand how weight loss affects sleep quality and related health issues. The study has two groups: one receiving ESG plus a program of diet, exercise, and behavioral therapy, and the other following the same lifestyle program without ESG. ESG involves reducing stomach size using stitches inserted through the mouth under general anesthesia, helping participants feel full sooner and eat less. Both groups follow a low-calorie diet and exercise routine for at least 12 months, with ongoing monitoring of weight loss and sleep apnea. Participants will have regular follow-up visits where their sleep apnea severity is measured using the Apnea-Hypopnea Index (AHI) and sleep quality questionnaires. Researchers will also track weight changes, metabolic health markers like blood sugar and cholesterol, and any procedure-related side effects. The study will last at least 24 months for some measures, with a primary focus on the improvement in OSA severity one year after treatment. Safety, quality of life, and long-term health impacts will also be evaluated throughout the study.
CONDITIONS
Brief Title
Effect of Weight Loss From ESG Plus Lifestyle Changes vs. Lifestyle Changes Alone in Sleep Apnea Patients
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Age over 18 years
- Obesity defined by ethnic specific BMI cut-offs and BMI less than 40 kg/m²
- Diagnosed with moderate to severe obstructive sleep apnea (Apnea-Hypopnea Index 15 or higher)
- Stable weight with less than 5 kg change within 3 months before screening
- Failure or inadequate weight loss from lifestyle changes or anti-obesity medications
- No planned additional weight loss treatments during the first 12 months after study treatment
- Willingness to follow the study protocol including follow-up visits and lifestyle modifications
- Able to understand and sign informed consent to participate
You will not qualify if you...
- Previous or planned surgery for sleep apnea or major ear, nose, or throat surgery
- Significant craniofacial abnormalities affecting breathing
- Diagnosis of central or mixed sleep apnea or Cheyne-Stokes respiration
- Other disorders causing insomnia or excessive daytime sleepiness besides OSA
- Obesity caused by other endocrine disorders or genetic/syndromic forms
- Active device treatment for OSA other than continuous positive airway pressure therapy
- Need for supplemental oxygen
- Previous bariatric or gastrointestinal surgery making ESG not feasible
- Active inflammatory bowel disease
- Current or planned pregnancy or breastfeeding
- Severe heart or lung conditions contraindicating endoscopy
- Uncontrolled psychiatric disorders
- Eating disorders impacting ability to follow lifestyle program
- History of substance abuse
- Use of medications affecting excessive sleepiness evaluation
- Recent changes or planned changes in diabetes medications affecting weight loss potential (e.g., GLP-1)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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2
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Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Implementation
Duration - 1 day for the ESG procedure; lifestyle modifications continue throughout treatment
Participants in the ESG plus lifestyle modification group undergo the Endoscopic Sleeve Gastroplasty procedure, a non-surgical endoscopic treatment to reduce stomach size, followed by lifestyle changes including diet, exercise, and behavioral therapy. Participants in the lifestyle modification alone group follow the structured program without the ESG procedure.
1 procedure visit for ESG group; ongoing lifestyle program visits as scheduled
Treatment
Duration - 12 months
Participants follow lifestyle modifications such as a low-calorie diet, regular physical activity, and behavioral therapy aimed at weight loss and improving sleep apnea symptoms.
Regular visits for assessments including weight, sleep quality, and apnea severity throughout 12 months
Follow-up
Duration - Up to 12 additional months after treatment
Participants continue to be monitored for weight loss maintenance, sleep apnea severity, and any procedure-related adverse events up to 24 months after treatment.
Periodic visits up to 24 months for follow-up assessments
Trial Site Locations
Total: 1 location
1
Asian Institute Of Gastroenterology Hospitals
Hyderabad, Telangana, India, 500032
Actively Recruiting
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Research Team
R
Rakesh Kalapala, MD, DNB
N
Nitin Jagtap, MD,DNB
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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Published Research Related To This Trial
Efficacy and Safety of Endoscopic Sleeve Gastroplasty: A Systematic Review and Meta-Analysis.
Abdellah Hedjoudje, Barham K Abu Dayyeh, Lawrence J Cheskin...
https://pubmed.ncbi.nlm.nih.gov/31442601Endoscopic Sleeve Gastroplasty for Obesity: a Multicenter Study of 248 Patients with 24 Months Follow-Up.
Gontrand Lopez-Nava, Reem Z Sharaiha, Eric J Vargas...
https://pubmed.ncbi.nlm.nih.gov/28451929Endoscopic Sleeve Gastroplasty Significantly Reduces Body Mass Index and Metabolic Complications in Obese Patients.
Reem Z Sharaiha, Nikhil A Kumta, Monica Saumoy...
https://pubmed.ncbi.nlm.nih.gov/28017845Improvement in Nocturnal Hypoxemia in Obese Patients with Obstructive Sleep Apnea after Bariatric Surgery: a Meta-Analysis.
Yuxiang Zhang, Wenyue Wang, Chengcan Yang...
https://pubmed.ncbi.nlm.nih.gov/30411226Long term maintenance of weight loss with non-surgical interventions in obese adults: systematic review and meta-analyses of randomised controlled trials.
S U Dombrowski, K Knittle, A Avenell...
https://pubmed.ncbi.nlm.nih.gov/25134100Weight reduction and the impact on apnea-hypopnea index: A systematic meta-analysis.
Atul Malhotra, Cory R Heilmann, Kushal K Banerjee...
https://pubmed.ncbi.nlm.nih.gov/38908268The Role of Weight Management in the Treatment of Adult Obstructive Sleep Apnea. An Official American Thoracic Society Clinical Practice Guideline.
David W Hudgel, Sanjay R Patel, Amy M Ahasic...
https://pubmed.ncbi.nlm.nih.gov/30215551