Metabolic Changes Associated With Weight Gain After Treatment of Achalasia

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Achalasia, Esophageal

Detailed Description

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.

The cases of achalasia will be reviewed thoroughly for demographic, clinical, laboratory, and manometric information.

Additionally, prior to POEM, the patient will be evaluated for:

• height, weight, and BMI;
• resting blood pressure;
• laboratory data including fasting glucose, Hgb A1c level, cholesterol panel, triglycerides, and liver function tests;
• Fibroscan (to measure hepatic steatosis and fibrosis).
• Eckhardt score
• Waist circumference
• Body fat percentage POEM or LHM will then be performed as indicated for achalasia treatment. One year after treatment, the initial testing will be repeated (including weight, blood pressure, fasting laboratory data, waist circumference, body fat percentage, and Fibroscan).

Statistical analyses Each patient's follow-up results will be compared to their pre-treatment results. Outcomes will include changes in levels of hepatic steatosis, waist circumference, body fat percentage, fasting glucose, Hgb A1c, cholesterol, liver function tests, and triglycerides compared to baseline, and the relationship in these changes to any weight gained. The primary outcome will be the change in hepatic steatosis on Fibroscan testing.

Continuous variables with a normal distribution will be reported as mean with standard deviation (SD), while those with a skewed distribution will be reported as median with interquartile range (IQR). Comparisons of categorical variables will be performed using the Chi-square test and Fisher's Exact test. Comparisons involving continuous variables will be performed using the Mann-Whitney U test. For all statistical calculations, a p-value <0.05 will be considered statistically significant.

• Study Type: Observational
• Enrollment (Estimated): 30

Contacts and Locations

• Study Contact: Name: Daniel Cohen, MD; Phone Number: 972-8-9779362; Email: docdannycohen@yahoo.com

Study Locations

• Israel
  • Jerusalem, Israel
    • Hadassah Medical Center
    • Contact: Sergei Vosko, MD; Phone Number: 972-3-9764260; Email: sergeivosko@gmail.com
  • Ẕerifin, Israel
    • Shamir medical center
    • Contact: Daniel Cohen, MD; Phone Number: 972-8-9779362; Email: docdannycohen@yahoo.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients diagnosed with achalasia and undergoing therapy with either POEM or LHM

Description

Inclusion Criteria:

• Proven achalasia
• Undergoing LHM or POEM for treatment

Exclusion Criteria:

• Under age 18
• Does no consent

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Increase in Hepatic steatosis	The degree of hepatic steatosis assessed on FibroScan at baseline compared to 1 year later	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
fasting glucose	Change in fasting glucose between baseline and 1 year later	1 year
Hgb A1c	Change in Hgb A1c level between baseline and 1 year later	1 year
Cholesterol	Change in cholesterol between baseline and 1 year later	1 year
Triglycerides	Change in triglycerides between baseline and 1 year later	1 year
Weight	Change in weight between baseline and 1 year later	1 year
waist circumference	Change in waist circumference between baseline and 1 year later	1 year
Body fat	Change in body fat percentage between baseline and 1 year later	1 year
LFTs	Change in liver function tests between baseline and 1 year later	1 year
Blood pressure	Change in resting blood pressure between baseline and 1 year later. Both the systolic and diastolic values will be assessed.	1 year
Eckhardt score	Change in Eckhardt score between baseline and 1 year later. The Eckhardt score goes from 0 to 12 with higher numbers meaning more severe symptoms.	1 year

Collaborators and Investigators

• Sponsor: Assaf-Harofeh Medical Center
• Collaborators: Hadassah Medical Organization

Publications and helpful links

General Publications

• Pandolfino JE, Gawron AJ. Achalasia: a systematic review. JAMA. 2015 May 12;313(18):1841-52. doi: 10.1001/jama.2015.2996.
• Patel DA, Vaezi MF. Achalasia and Nutrition: Is it Simple Physics or Biology. Pract Gastro. 2016 Nov;40(11):42-48.

Study record dates

Study Major Dates

• Study Start (Estimated): January 15, 2026
• Primary Completion (Estimated): January 1, 2028
• Study Completion (Estimated): January 1, 2029

Study Registration Dates

• First Submitted: December 31, 2025
• First Submitted That Met QC Criteria: December 31, 2025
• First Posted (Estimated): January 12, 2026

Study Record Updates

• Last Update Posted (Actual): January 13, 2026
• Last Update Submitted That Met QC Criteria: January 11, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: obesity; metabolic syndrome; weight gain; achalasia; hepatic steatosis
• Additional Relevant MeSH Terms: Nutrition Disorders; Metabolic Diseases; Overnutrition; Body Weight; Body Weight Changes; Digestive System Diseases; Gastrointestinal Diseases; Glucose Metabolism Disorders; Liver Diseases; Esophageal Diseases; Insulin Resistance; Hyperinsulinism; Overweight; Esophageal Motility Disorders; Deglutition Disorders; Pathological Conditions, Signs and Symptoms; Nutritional and Metabolic Diseases; Signs and Symptoms; Obesity; Metabolic Syndrome; Fatty Liver; Weight Gain; Esophageal Achalasia
• Other Study ID Numbers: 0290-25-ASF

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: The confidential information will only be used for this study.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No