EGG Test as a Predictor for an Individual Response to Treatment by Various Bariatric Procedures
Gastric Myoelectric Activity With Water Load Satiety Test as a Predictor of Individual Successful Response to Treatment by Various Bariatric Procedures.
Studieoversigt
Status
Intervention / Behandling
Detaljeret beskrivelse
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
Undersøgelsestype
Tilmelding (Forventet)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiekontakt
- Navn: Neeraj Singla, MBBS,MD,DM
- Telefonnummer: 7013454913
- E-mail: docneersk@gmail.com
Studiesteder
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Telangana
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Hyderabad, Telangana, Indien, 500032
- Rekruttering
- AIG Hospitals
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
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
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Diagnostisk
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Andet: Group A
Group of 50 patients who undergo BIG placement
|
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.
|
|
Andet: Group B
Group of 50 patients who undergo endoscopic sleeve gastroplasty
|
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.
|
|
Andet: Group C
Group of 50 patients who undergo Surgical sleeve gastrectomy
|
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.
|
|
Andet: Group D
Group of 50 patients who undergo RYGB
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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.
|
|
Andet: Group E
Group of 50 healthy subjects
|
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.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Changes in EGG parameters like WLST (water load satiety test) GMA Gastric myoelectric activity),Predominant frequency of stomach.
Tidsramme: 1st or 3rd month of baritaric surgery
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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
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1st or 3rd month of baritaric surgery
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Changes in EGG parameters like WLST (water load satiety test) GMA Gastric myoelectric activity),Predominant frequency of stomach at end of the follow up.
Tidsramme: 18-24 month
|
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
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18-24 month
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
EGG as a diagnostic tool to measure WLST (water load satiety test) GMA Gastric myoelectric activity),Predominant frequency of stomach.
Tidsramme: 12-18 måneder
|
EGG er et gennemførligt diagnostisk værktøj i overvægtige populationer med reproducerbare og forudsigelige resultater
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12-18 måneder
|
Samarbejdspartnere og efterforskere
Efterforskere
- Studieleder: Rakesh Kalpala, MBBS,MD,DM, Senior consultant
Publikationer og nyttige links
Generelle publikationer
- 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.
- 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.
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Forventet)
Studieafslutning (Forventet)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- AIG/IEC-BH&R32/07.2022-02
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Kliniske forsøg med Gastroparese
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The Cleveland ClinicAktiv, ikke rekrutterendeGastroparesis-lignende symptomerForenede Stater