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临床试验/NCT05731531
NCT05731531Unknown不适用

Gastric Myoelectric Activity With Water Load Satiety Test as a Predictor of Individual Successful Response to Treatment by Various Bariatric Procedures.

Asian Institute of Gastroenterology, India1 个研究点 分布在 1 个国家目标入组 250 人开始时间: 2022年11月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
发起方
入组人数
250
试验地点
1
主要终点
Changes in EGG parameters like WLST (water load satiety test) GMA Gastric myoelectric activity),Predominant frequency of stomach.

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •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.

排除标准

  • •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

研究组 & 干预措施

Group A

Other

Group of 50 patients who undergo BIG placement

干预措施: ELECTROGASTROGRAPHY (Device)

Group B

Other

Group of 50 patients who undergo endoscopic sleeve gastroplasty

干预措施: ELECTROGASTROGRAPHY (Device)

Group C

Other

Group of 50 patients who undergo Surgical sleeve gastrectomy

干预措施: ELECTROGASTROGRAPHY (Device)

Group D

Other

Group of 50 patients who undergo RYGB

干预措施: ELECTROGASTROGRAPHY (Device)

Group E

Other

Group of 50 healthy subjects

干预措施: ELECTROGASTROGRAPHY (Device)

结局指标

主要结局

Changes in EGG parameters like WLST (water load satiety test) GMA Gastric myoelectric activity),Predominant frequency of stomach.

时间窗: 1st or 3rd month of baritaric surgery

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.

时间窗: 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

次要结局

  • EGG as a diagnostic tool to measure WLST (water load satiety test) GMA Gastric myoelectric activity),Predominant frequency of stomach.(12-18 months)

研究者

发起方
Asian Institute of Gastroenterology, India
申办方类型
Other
责任方
Principal Investigator
主要研究者

Rakesh Kalapala

Director Endoscopy (center for obesity and metabolic therapy)

Asian Institute of Gastroenterology, India

研究点 (1)

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