Bariatric Surgery Clinical Trial
Official title:
Gastric Myoelectric Activity With Water Load Satiety Test as a Predictor of Individual Successful Response to Treatment by Various Bariatric Procedures.
Total body weight loss (TBWL) after bariatric endoscopy (BE) is variable. Gastric emptying may be normal, rapid or delayed in patients with obesity and be a factor in variable BE outcomes. Gastric myoelectrical activity (GMA) reflects gastric pacemaker activity which controls gastric contractions. The non-invasive electrogastrogram(EGG) uses standard electrodes positioned on the abdominal surface to record GMA. The investigators postulate that GMA patterns recorded with EGG will reflect subgroups in regards to stomach electrical physiology in obesity and that these subgroups will be useful in selecting patients for various BE procedures to maximize success of the procedures.
Status | Recruiting |
Enrollment | 250 |
Est. completion date | December 2024 |
Est. primary completion date | December 2023 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility | Inclusion Criteria: - Men and women, aged between 18-65 yrs - IMC basal = 30 kg/m2 - Patient undergoing bariatric intervention willing to participate in the study - Informed consent (oral and written) for the tests to be carried out. Exclusion Criteria: - Presence of severe cardiac, renal, hepatic, or neurological disease - Long term use of medication that alter gastric motility (> 4 weeks) - Significant alcohol or opioids or narcotics or tobacco - Active malignancy 5.Pregnancy |
Country | Name | City | State |
---|---|---|---|
India | AIG Hospitals | Hyderabad | Telangana |
Lead Sponsor | Collaborator |
---|---|
Asian Institute of Gastroenterology, India |
India,
Jirapinyo P, Thompson CC. Endoscopic Bariatric and Metabolic Therapies: Surgical Analogues and Mechanisms of Action. Clin Gastroenterol Hepatol. 2017 May;15(5):619-630. doi: 10.1016/j.cgh.2016.10.021. Epub 2016 Oct 28. — View Citation
Kral J, Machytka E, Horka V, Selucka J, Dolecek F, Spicak J, Kovarova V, Haluzik M, Buzga M. Endoscopic Treatment of Obesity and Nutritional Aspects of Bariatric Endoscopy. Nutrients. 2021 Nov 26;13(12):4268. doi: 10.3390/nu13124268. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Changes in EGG parameters like WLST (water load satiety test) GMA Gastric myoelectric activity),Predominant frequency of stomach. | Pre-intervention EGG parameters and/or changes in EGG parameters (one/three months) after bariatric intervention can predict clinical success at the end the of follow up | 1st or 3rd month of baritaric surgery | |
Primary | Changes in EGG parameters like WLST (water load satiety test) GMA Gastric myoelectric activity),Predominant frequency of stomach at end of the follow up. | Pre-intervention EGG parameters and/or changes in EGG parameters (one/three months) after bariatric intervention can predict clinical success at the end the of follow up | 18-24 month | |
Secondary | EGG as a diagnostic tool to measure WLST (water load satiety test) GMA Gastric myoelectric activity),Predominant frequency of stomach. | EGG is a feasible diagnostic tool in obese population with reproducible and predictible results | 12-18 months |
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