AzTrials
AzTrials

Achalasia, EsophagealNCT07334639

Metabolic Changes Associated With Weight Gain After Treatment of Achalasia

An observational study of Achalasia, Esophageal, run by Assaf-Harofeh Medical Center at 2 sites in Israel.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Achalasia, Esophageal
Type of treatment
Pill or oral medicine
How many people
30 participants
Where
2 sitesIsrael
Study dates
15 Jan 2026to 1 Jan 2029
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Patients diagnosed with achalasia and undergoing therapy with either POEM or LHM

Who may be able to join

  • Proven achalasia
  • Undergoing LHM or POEM for treatment

Who cannot join

  • Under age 18
  • Does no consent

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Daniel Cohen, MD contact

972-8-9779362

docdannycohen@yahoo.com

Israel2 sites
  • Hadassah Medical Center

    Jerusalem

    Sergei Vosko, MD, 972-3-9764260, sergeivosko@gmail.com

  • Shamir Medical Center

    Tsrifin

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

Other trials in Israel

About this study

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.

Keywords
achalasia, weight gain, obesity, metabolic syndrome, hepatic steatosis
Medical subject headings
Esophageal Achalasia, Weight Gain, Obesity, Metabolic Syndrome, Fatty Liver

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT07334639
Study groupRoleWhat they receive
Achalasia patientsPatients 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 being measured

The primary outcome is the main question the study is designed to answer.

  1. Increase in Hepatic steatosis

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

    Measured: 1 year

Secondary outcomes (10)
  1. fasting glucose

    Change in fasting glucose between baseline and 1 year later

    Measured: 1 year

  2. Hgb A1c

    Change in Hgb A1c level between baseline and 1 year later

    Measured: 1 year

  3. Cholesterol

    Change in cholesterol between baseline and 1 year later

    Measured: 1 year

  4. Triglycerides

    Change in triglycerides between baseline and 1 year later

    Measured: 1 year

  5. Weight

    Change in weight between baseline and 1 year later

    Measured: 1 year

  6. waist circumference

    Change in waist circumference between baseline and 1 year later

    Measured: 1 year

  7. Body fat

    Change in body fat percentage between baseline and 1 year later

    Measured: 1 year

  8. LFTs

    Change in liver function tests between baseline and 1 year later

    Measured: 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.

    Measured: 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.

    Measured: 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Jan 2026
  2. Study start15 Jan 2026 (estimated)
  3. Primary completion1 Jan 2028 (estimated)
  4. Study completion1 Jan 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07334639
Sponsor's protocol ID
0290-25-ASF
Status last verified
Jan 2026
First submitted
31 Dec 2025
Last updated
13 Jan 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: The confidential information will only be used for this study.

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

Questions about this trial

What is this clinical trial studying?

An observational study of Achalasia, Esophageal, run by Assaf-Harofeh Medical Center at 2 sites in Israel.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 13 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Daniel Cohen, MD (972-8-9779362, docdannycohen@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Increase in Hepatic steatosis (time frame: 1 year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07334639, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jan 2026.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in