Clinical trial NCT05731531: EGG Test as a Predictor for an Individual Response to Treatment by Various Bariatric Procedures
Official title: Gastric Myoelectric Activity With Water Load Satiety Test as a Predictor of Individual Successful Response to Treatment by Various Bariatric Procedures.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Bariatric Surgery
Gastric Motor Dysfunction
Gastroparesis
Keywords: Bariatric surgery
Electrogastrography
Gastric Myoelectric activity
Lead sponsor: Asian Institute of Gastroenterology, India
Sponsor class: OTHER
First posted: 2023-02-16
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: 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.

Detailed description: Electrogastrography is a non-invasive method of recording GMA that is used to diagnose gastric dysrythmias in patients with intractable chronic nausea and vomiting, gastroparesis and gastroesophageal reflux.

Bariatric Techniques: 3 categories 1)restrictive,2) mal absorptive 3)mixed Bariatric endoscopy techniques have emerged as safe and effective treatment that include restrictive endoscopic techniques: Intragastric balloons or endoscopic sleeve gastroplasty(ESG),primary surgery obesity endoluminal (POSE) or Endo-sleeve (GESP or POSE 2.0) procedures; malabsorptive techniques :endoluminal bypass (endobarrier),duodenal mucosa resurfacing; extraction methods (Aspire); electrical stimulation : gastric pacemaker, vagal blockage and other procedures.

Weight loss and long-term maintenance may be conditioned by changes in GMA, as well as by anatomical modifications induced by the bariatric procedure.

Since anatomical modifications of the stomach by the BE procedures are related to weight loss, The purpose is to determine whether different procedures to reduce gastric capacity will result in substantial changes in GMA and in the water load volume ingested. No studies that have studied obese population before and after such BE procedures are available.

Therefore, whether obese patients have the GMA that is similar to those with functional dyspepsia and normal weight . Also, the usefulness of electrogastrography as a new tool to customize choice of Bariatric therapies by determining success or failure based on GMA and WLST results has not been studied. GMA measures the normal or depleted gastric ICCs and the WLST measures gastric capacity, objective measures that may be important to predict success of Bariatric procedures and thus to help with patient selection to maximize efficacy and minimize side effects.

Demonstrate the usefulness of EGG meizuring the GMA by identifying subtypes with the Water Load Satiety Test (WLST) in obese adults to predict individual successful responses to BE treatments: Intragastric Balloon (IGB) placement and Apollo Endoscopic Sleeve Gastroplasty (ESG) method

Eligibility criteria: 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

Primary outcomes:
measure: Changes in EGG parameters like WLST (water load satiety test) GMA Gastric myoelectric activity),Predominant frequency of stomach.
timeFrame: 1st or 3rd month of baritaric surgery
measure: Changes in EGG parameters like WLST (water load satiety test) GMA Gastric myoelectric activity),Predominant frequency of stomach at end of the follow up.
timeFrame: 18-24 month
Secondary outcomes:
measure: EGG as a diagnostic tool to measure WLST (water load satiety test) GMA Gastric myoelectric activity),Predominant frequency of stomach.
timeFrame: 12-18 months
Other outcomes:
Locations:
city: Hyderabad
country: India
facility: AIG Hospitals
state: Telangana
Study officials:
affiliation: Senior consultant
name: Rakesh Kalpala, MBBS,MD,DM
role: STUDY_DIRECTOR
References:
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.
citation: 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.