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

Primary Purpose

Bariatric Surgery, Gastric Motor Dysfunction, Gastroparesis

Status
Recruiting
Phase
Not Applicable
Locations
India
Study Type
Interventional
Intervention
ELECTROGASTROGRAPHY
Sponsored by
Asian Institute of Gastroenterology, India
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Bariatric Surgery focused on measuring Bariatric surgery, Electrogastrography, Gastric Myoelectric activity

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • AIG HospitalsRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Other

Other

Other

Other

Other

Arm Label

Group A

Group B

Group C

Group D

Group E

Arm Description

Group of 50 patients who undergo BIG placement

Group of 50 patients who undergo endoscopic sleeve gastroplasty

Group of 50 patients who undergo Surgical sleeve gastrectomy

Group of 50 patients who undergo RYGB

Group of 50 healthy subjects

Outcomes

Primary Outcome Measures

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
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

Secondary Outcome Measures

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

Full Information

First Posted
November 14, 2022
Last Updated
February 7, 2023
Sponsor
Asian Institute of Gastroenterology, India
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1. Study Identification

Unique Protocol Identification Number
NCT05731531
Brief Title
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

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 1, 2022 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Asian Institute of Gastroenterology, India

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bariatric Surgery, Gastric Motor Dysfunction, Gastroparesis
Keywords
Bariatric surgery, Electrogastrography, Gastric Myoelectric activity

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
250 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group A
Arm Type
Other
Arm Description
Group of 50 patients who undergo BIG placement
Arm Title
Group B
Arm Type
Other
Arm Description
Group of 50 patients who undergo endoscopic sleeve gastroplasty
Arm Title
Group C
Arm Type
Other
Arm Description
Group of 50 patients who undergo Surgical sleeve gastrectomy
Arm Title
Group D
Arm Type
Other
Arm Description
Group of 50 patients who undergo RYGB
Arm Title
Group E
Arm Type
Other
Arm Description
Group of 50 healthy subjects
Intervention Type
Device
Intervention Name(s)
ELECTROGASTROGRAPHY
Intervention Description
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.
Primary Outcome Measure Information:
Title
Changes in EGG parameters like WLST (water load satiety test) GMA Gastric myoelectric activity),Predominant frequency of stomach.
Description
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
Time Frame
1st or 3rd month of baritaric surgery
Title
Changes in EGG parameters like WLST (water load satiety test) GMA Gastric myoelectric activity),Predominant frequency of stomach at end of the follow up.
Description
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
Time Frame
18-24 month
Secondary Outcome Measure Information:
Title
EGG as a diagnostic tool to measure WLST (water load satiety test) GMA Gastric myoelectric activity),Predominant frequency of stomach.
Description
EGG is a feasible diagnostic tool in obese population with reproducible and predictible results
Time Frame
12-18 months

10. Eligibility

Sex
All
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Neeraj Singla, MBBS,MD,DM
Phone
7013454913
Email
docneersk@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rakesh Kalpala, MBBS,MD,DM
Organizational Affiliation
Senior consultant
Official's Role
Study Director
Facility Information:
Facility Name
AIG Hospitals
City
Hyderabad
State/Province
Telangana
ZIP/Postal Code
500032
Country
India
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
34959819
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.
Results Reference
background
PubMed Identifier
27989851
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.
Results Reference
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EGG Test as a Predictor for an Individual Response to Treatment by Various Bariatric Procedures

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