Clinical Trials Directory

Trials / Enrolling By Invitation

Enrolling By InvitationNCT03063463

Mechanisms of Weight Loss in Patients Diagnosed With Achalasia

Mechanisms of Weight Loss in Patients Diagnosed With Achalasia: A Prospective Observational Study

Status
Enrolling By Invitation
Phase
Study type
Observational
Enrollment
50 (estimated)
Sponsor
Vanderbilt University Medical Center · Academic / Other
Sex
All
Age
18 Years – 75 Years
Healthy volunteers
Not accepted

Summary

Currently there are no existing data to determine why some achalasia patients lose weight while others do not. The purpose of this study is to gather data from patients diagnosed with achalasia to determine if differences may be identified between those who lose weight and those who do not that would help us better understand the mechanism of weight loss in this population.

Detailed description

Patients either diagnosed with or being evaluated for achalasia and scheduled for standard clinic visits with the principal investigator as part of their routine care will be considered for participation in this study. Blood work, vital signs, and 24-hour dietary recall will be collected over a period of one year. These data will lay the foundation for future scientific endeavors to : a) assess requirements for dietary and/or nutritional supplements; b) formulate an achalasia diet; c) develop clinical practice standards; and d) design an intervention study.

Conditions

Interventions

TypeNameDescription
PROCEDUREpneumatic dilationPneumatic dilation of the lower esophageal sphincter (LES) consists of inserting a guide wire under visual control into the stomach and to pass the balloon over the guide wire. The balloon is inflated, disrupting the muscle fibers of the sphincter.
PROCEDUREsurgical myotomyThis procedure destroys the muscles at the gastroesophageal junction, allowing the valve (LES) between the esophagus and stomach to remain open.

Timeline

Start date
2017-02-15
Primary completion
2026-06-01
Completion
2026-06-01
First posted
2017-02-24
Last updated
2025-05-16

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT03063463. Inclusion in this directory is not an endorsement.