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

NCT05731531 | Unknown DMC FDA Device

• 1 other identifier: AIG/IEC-BH&R32/07.2022-02
• Study Type: interventional
• Target: 250
• Locations: 1 country
• Sites: 1

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.

Conditions

Bariatric Surgery; Gastric Motor Dysfunction; Gastroparesis

Keywords

Bariatric surgery; Electrogastrography; Gastric Myoelectric activity

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (1)

• EGG as a diagnostic tool to measure WLST (water load satiety test) GMA Gastric myoelectric activity),Predominant frequency of stomach.

  12-18 months

Study Arms (5)

Group A

OTHER

Group of 50 patients who undergo BIG placement

Device: ELECTROGASTROGRAPHY

Group B

OTHER

Group of 50 patients who undergo endoscopic sleeve gastroplasty

Device: ELECTROGASTROGRAPHY

Group C

OTHER

Group of 50 patients who undergo Surgical sleeve gastrectomy

Device: ELECTROGASTROGRAPHY

Group D

OTHER

Group of 50 patients who undergo RYGB

Device: ELECTROGASTROGRAPHY

Group E

OTHER

Group of 50 healthy subjects

Device: ELECTROGASTROGRAPHY

Interventions

ELECTROGASTROGRAPHY DEVICE

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.

Group A; Group B; Group C; Group D; Group E

Eligibility Criteria

• Age: 18 Years - 65 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Asian Institute of Gastroenterology, India: lead

Study Sites (1)

AIG Hospitals

Hyderabad, Telangana, 500032, India

RECRUITING

Related Publications (2)

• 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.

  PMID: 34959819 BACKGROUND

• 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.

  PMID: 27989851 BACKGROUND

MeSH Terms

Conditions

Gastroparesis

Condition Hierarchy (Ancestors)

Stomach Diseases; Gastrointestinal Diseases; Digestive System Diseases; Paralysis; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Rakesh Kalpala, MBBS,MD,DM

  Senior consultant

  STUDY DIRECTOR

Central Study Contacts

Neeraj Singla, MBBS,MD,DM

CONTACT

7013454913; docneersk@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director Endoscopy (center for obesity and metabolic therapy)

Study Record Dates

• First Submitted: November 14, 2022
• First Posted: February 16, 2023
• Study Start: November 1, 2022
• Primary Completion: December 1, 2023
• Study Completion: December 1, 2024
• Last Updated: February 16, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)