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Not yet recruitingNCT07334639Updated Jan 13, 2026

Metabolic Changes Associated With Weight Gain After Treatment of Achalasia

An observational study in Achalasia, Esophageal, sponsored by Assaf-Harofeh Medical Center. Not yet recruiting at 2 sites in Israel. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-01-13.

Sponsored by Assaf-Harofeh Medical Center · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
30
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Achalasia, Esophageal

Keywords

  • achalasia
  • weight gain
  • obesity
  • metabolic syndrome
  • hepatic steatosis
03

In context

Esophageal Achalasia

143 studies on the registry are indexed under Esophageal Achalasia; 44 are open to participants now.

This study's planned enrollment of 30 is below the median of 111 across 41 observational studies indexed under Esophageal Achalasia.

Browse Esophageal Achalasia studies →

Lead sponsor

Assaf-Harofeh Medical Center is the lead sponsor of 267 studies on the registry; 43 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Proven achalasia
  • Undergoing LHM or POEM for treatment

Exclusion criteria

Exclusion Criteria:

  • Under age 18
  • Does no consent
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
30 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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.

06

What researchers measure

Primary outcomes

  1. Increase in Hepatic steatosis

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

    Time frame: 1 year

Secondary outcomes

  1. fasting glucose

    Change in fasting glucose between baseline and 1 year later

    Time frame: 1 year

  2. Hgb A1c

    Change in Hgb A1c level between baseline and 1 year later

    Time frame: 1 year

  3. Cholesterol

    Change in cholesterol between baseline and 1 year later

    Time frame: 1 year

  4. Triglycerides

    Change in triglycerides between baseline and 1 year later

    Time frame: 1 year

  5. Weight

    Change in weight between baseline and 1 year later

    Time frame: 1 year

  6. waist circumference

    Change in waist circumference between baseline and 1 year later

    Time frame: 1 year

  7. Body fat

    Change in body fat percentage between baseline and 1 year later

    Time frame: 1 year

  8. LFTs

    Change in liver function tests between baseline and 1 year later

    Time frame: 1 year

  9. Blood pressure

    Change in resting blood pressure between baseline and 1 year later. Both the systolic and diastolic values will be assessed.

    Time frame: 1 year

  10. 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.

    Time frame: 1 year

07

Study locations

2 sites
08

References and documents

Publications

  • Patel DA, Vaezi MF. Achalasia and Nutrition: Is it Simple Physics or Biology. Pract Gastro. 2016 Nov;40(11):42-48.
  • Pandolfino JE, Gawron AJ. Achalasia: a systematic review. JAMA. 2015 May 12;313(18):1841-52. doi: 10.1001/jama.2015.2996. PubMed 25965233 ↗

Individual participant data

Plan to share: No — The confidential information will only be used for this study.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 13, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07334639
Responsible party
Daniel Cohen (Gastroenterologist, Assaf-Harofeh Medical Center) — Principal investigator
First posted
Jan 12, 2026
Start date
Jan 15, 2026 (estimated)
Primary completion
Jan 1, 2028 (estimated)
Completion
Jan 1, 2029 (estimated)
Last update
Jan 13, 2026

Study contacts

Daniel Cohen, MD
Contact
docdannycohen@yahoo.com
972-8-9779362

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Jan 2026. You cannot join it, but the record below documents what was studied.

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