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Metabolic Changes Associated With Weight Gain After Treatment of Achalasia

Metabolic Changes Associated With Weight Gain After Treatment of Achalasia

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07334639
Enrollment
30
Registered
2026-01-12
Start date
2026-01-15
Completion date
2029-01-01
Last updated
2026-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Achalasia, Esophageal

Keywords

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

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.

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.

Interventions

None listed

Sponsors

Hadassah Medical Organization
CollaboratorOTHER
Assaf-Harofeh Medical Center
Lead SponsorOTHER_GOV

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Proven achalasia * Undergoing LHM or POEM for treatment

Exclusion criteria

* Under age 18 * Does no consent

Design outcomes

Primary

MeasureTime frameDescription
Increase in Hepatic steatosis1 yearThe degree of hepatic steatosis assessed on FibroScan at baseline compared to 1 year later

Secondary

MeasureTime frameDescription
Hgb A1c1 yearChange in Hgb A1c level between baseline and 1 year later
Cholesterol1 yearChange in cholesterol between baseline and 1 year later
Triglycerides1 yearChange in triglycerides between baseline and 1 year later
Weight1 yearChange in weight between baseline and 1 year later
fasting glucose1 yearChange in fasting glucose between baseline and 1 year later
Body fat1 yearChange in body fat percentage between baseline and 1 year later
LFTs1 yearChange in liver function tests between baseline and 1 year later
Blood pressure1 yearChange in resting blood pressure between baseline and 1 year later. Both the systolic and diastolic values will be assessed.
Eckhardt score1 yearChange in Eckhardt score between baseline and 1 year later. The Eckhardt score goes from 0 to 12 with higher numbers meaning more severe symptoms.
waist circumference1 yearChange in waist circumference between baseline and 1 year later

Countries

Israel

Contacts

Primary ContactDaniel Cohen, MD
docdannycohen@yahoo.com972-8-9779362

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026