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临床试验/NCT07334639
NCT07334639尚未招募不适用

Metabolic Changes Associated With Weight Gain After Treatment of Achalasia

Assaf-Harofeh Medical Center2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2026年1月15日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
30
试验地点
2
主要终点
Increase in Hepatic steatosis

研究概览

简要总结

This goal of the study is to assess the effect of weight gain in patients with achalasia after they are treated. The main question to be answered is if weight gain after achalasia treatment is associated with worsening metabolic status. Patients will be compared between their baseline status at the time of treatment and 1 year after treatment. Participants will have metabolic tests performed at these 2 times including blood tests.

详细描述

Background Achalasia is a disease characterized by the loss of the myenteric neurons that coordinate esophageal peristalsis and lower esophageal sphincter (LES) relaxation.1 As a result, there is aperistalsis of the esophagus and impaired LES relaxation after deglutition. The primary symptoms are dysphagia, regurgitation, and chest pain.

Weight loss is also common.2 Studies have shown weight loss occurring in between 35-69% of achalasia patients.3,4 One study reported that patients with Type II Achalasia were more likely to have weight loss than the other subtypes.5 Studies have also shown that patients with achalasia, even when not underweight, are at risk of malnutrition.6 Recently, studies have begun assessing the weight gain that occurs after successful treatment of achalasia.7-10 These studies have evaluated achalasia patients after laparoscopic Heller myotomy (LHM),7 peroral endoscopic myotomy (POEM),8,9 or a combination of treatment modalities.10 They have consistently shown significant weight gain after treatment, with many patients becoming overweight or obese.

However, the impact of this weight gain has not been objectively evaluated. Thus, to our knowledge, no studies have evaluated the cardiovascular or metabolic effects of this post-treatment weight gain.

Goals Therefore, we aim to evaluate the metabolic effects of post-treatment weight gain in in a cohort of achalasia patients undergoing treatment by assessing the relationship between weight gain and glycemic control, cholesterol levels, blood pressure, and hepatic steatosis.

Methods A prospective pilot study will be performed at both Shamir Medical Center and Hadassah Medical Center. All adult patients diagnosed with achalasia and undergoing either POEM or LHM for treatment of achalasia will be included.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

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

入选标准

  • Proven achalasia
  • Undergoing LHM or POEM for treatment

排除标准

  • Under age 18
  • Does no consent

研究组 & 干预措施

Achalasia patients

Patients with achalasia who undergoing treatment with either per oral endoscopic myotomy (POEM) or laparoscopic Heller myotomy (LHM). Each participant's metabolic status will be evaluated at the time of treatment and one year later.

结局指标

主要结局

Increase in Hepatic steatosis

时间窗: 1 year

The degree of hepatic steatosis assessed on FibroScan at baseline compared to 1 year later

次要结局

  • fasting glucose(1 year)
  • Hgb A1c(1 year)
  • Cholesterol(1 year)
  • Triglycerides(1 year)
  • Weight(1 year)
  • waist circumference(1 year)
  • Body fat(1 year)
  • LFTs(1 year)
  • Blood pressure(1 year)
  • Eckhardt score(1 year)

研究者

申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Daniel Cohen

Gastroenterologist

Assaf-Harofeh Medical Center

研究点 (2)

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