Metabolic Changes Associated With Weight Gain After Treatment of Achalasia

NCT07334639 | Not Yet Recruiting

• 1 other identifier: 0290-25-ASF
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Achalasia, Esophageal

Keywords

achalasia; weight gain; obesity; metabolic syndrome; hepatic steatosis

Outcome Measures

Primary Outcomes (1)

• Increase in Hepatic steatosis

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

  1 year

Secondary Outcomes (10)

• fasting glucose

  1 year

• Hgb A1c

  1 year

• Cholesterol

  1 year

• Triglycerides

  1 year

• Weight

  1 year

Study Arms (1)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• Proven achalasia
• Undergoing LHM or POEM for treatment

You may not qualify if:

• Under age 18
• Does no consent

Sponsors & Collaborators

• Assaf-Harofeh Medical Center: lead
• Hadassah Medical Organization: collaborator

Study Sites (2)

Hadassah Medical Center

Jerusalem, Israel

Location

Shamir Medical Center

Ẕerifin, Israel

Location

Related Publications (2)

• Patel DA, Vaezi MF. Achalasia and Nutrition: Is it Simple Physics or Biology. Pract Gastro. 2016 Nov;40(11):42-48.

  BACKGROUND

• Pandolfino JE, Gawron AJ. Achalasia: a systematic review. JAMA. 2015 May 12;313(18):1841-52. doi: 10.1001/jama.2015.2996.

  PMID: 25965233 BACKGROUND

MeSH Terms

Conditions

Esophageal Achalasia; Weight Gain; Obesity; Metabolic Syndrome; Fatty Liver

Condition Hierarchy (Ancestors)

Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Body Weight Changes; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Liver Diseases

Central Study Contacts

Daniel Cohen, MD

CONTACT

972-8-9779362; docdannycohen@yahoo.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Gastroenterologist

Study Record Dates

• First Submitted: December 31, 2025
• First Posted: January 12, 2026
• Study Start: January 15, 2026
• Primary Completion (Estimated): January 1, 2028
• Study Completion (Estimated): January 1, 2029
• Last Updated: January 13, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

IL (2)