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.
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.
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
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.
- Conditions
- Achalasia, Esophageal
- 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 group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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)
fasting glucose
Change in fasting glucose between baseline and 1 year later
Measured: 1 year
Hgb A1c
Change in Hgb A1c level between baseline and 1 year later
Measured: 1 year
Cholesterol
Change in cholesterol between baseline and 1 year later
Measured: 1 year
Triglycerides
Change in triglycerides between baseline and 1 year later
Measured: 1 year
Weight
Change in weight between baseline and 1 year later
Measured: 1 year
waist circumference
Change in waist circumference between baseline and 1 year later
Measured: 1 year
Body fat
Change in body fat percentage between baseline and 1 year later
Measured: 1 year
LFTs
Change in liver function tests between baseline and 1 year later
Measured: 1 year
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
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.
- First posted12 Jan 2026
- Study start15 Jan 2026 (estimated)
- Primary completion1 Jan 2028 (estimated)
- Study completion1 Jan 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Achalasia, EsophagealStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Assaf-Harofeh Medical Center
- Sponsor type
- Other government
- Collaborators
- Hadassah Medical Organization
- Responsible party
- Principal investigator, Daniel Cohen, Assaf-Harofeh Medical Center
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
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Metabolic Changes Associated With Weight Gain After Treatment of Achalasia
- ClinicalTrials.gov ID
- NCT07334639
- Acronym / sponsor ID
- 0290-25-ASF
- Conditions
- Achalasia, Esophageal
- Keywords
- achalasia, weight gain, obesity, metabolic syndrome, hepatic steatosis
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Assaf-Harofeh Medical CenterOther government
- Collaborators
- Hadassah Medical Organization
- Study start
- 15 Jan 2026 (estimated)
- Primary completion
- 1 Jan 2028 (estimated)
- Study completion
- 1 Jan 2029 (estimated)
- First posted
- 12 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients diagnosed with achalasia and undergoing therapy with either POEM or LHM
Key inclusion criteria (2 listed)
- Proven achalasia
- Undergoing LHM or POEM for treatment
Key exclusion criteria (2 listed)
- Under age 18
- Does no consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Increase in Hepatic steatosis
Time frame: 1 year
The degree of hepatic steatosis assessed on FibroScan at baseline compared to 1 year later
10 secondary outcomes
fasting glucose
Time frame: 1 year
Hgb A1c
Time frame: 1 year
Cholesterol
Time frame: 1 year
Triglycerides
Time frame: 1 year
Weight
Time frame: 1 year
waist circumference
Time frame: 1 year
Body fat
Time frame: 1 year
LFTs
Time frame: 1 year
Blood pressure
Time frame: 1 year
Eckhardt score
Time frame: 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2026.
- BackgroundPatel DA, Vaezi MF. Achalasia and Nutrition: Is it Simple Physics or Biology. Pract Gastro. 2016 Nov;40(11):42-48.
- Background: PubMed 25965233Pandolfino JE, Gawron AJ. Achalasia: a systematic review. JAMA. 2015 May 12;313(18):1841-52. doi: 10.1001/jama.2015.2996.
- Individual participant dataSharing planned: No. The confidential information will only be used for this study.
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Achalasia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
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.