EGG Test as a Predictor for an Individual Response to Treatment by Various Bariatric Procedures

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05731531
• Other study ID #: AIG/IEC-BH&R32/07.2022-02
• Status: Recruiting
• Phase: N/A
• Start date: November 1, 2022
• Est. completion date: December 2024

Study information

• Verified date: February 2023
• Source: Asian Institute of Gastroenterology, India
• Contact: Neeraj Singla, MBBS,MD,DM
• Phone: 7013454913
• Email: docneersk[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Bariatric Surgery
• Gastric Motor Dysfunction
• Gastroparesis

Intervention

Device:
• ELECTROGASTROGRAPHY
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.

Locations

Country	Name	City	State
India	AIG Hospitals	Hyderabad	Telangana

Sponsors (1)

Lead Sponsor	Collaborator
Asian Institute of Gastroenterology, India

Country where clinical trial is conducted

India, 

References & Publications (2)

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

Outcome

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