Mechanisms of Weight Loss in Patients Diagnosed With Achalasia

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

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Achalasia
• Intervention / Treatment: Procedure: pneumatic dilation; Procedure: surgical myotomy

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.

• Study Type: Observational
• Enrollment (Anticipated): 50

Contacts and Locations

Study Locations

• United States
  • Tennessee
    • Nashville, Tennessee, United States, 37212
      • Vanderbilt University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients either diagnosed with or being evaluated for achalasia and scheduled for standard clinic visits with the principal investigator or a sub-investigator as part of their routine care.

Description

Inclusion Criteria:

1. Subject is able to provide written informed consent to participate in the study before completing any study-related procedures
2. Subject is male or female aged 18-75 years, inclusive at time of consent.
3. Subject has a documented diagnosis of achalasia based on high resolution manometry and endoscopy report.
4. Subject has been or will be scheduled to undergo either EGD with pneumatic dilation or surgical myotomy as routine care for treatment of achalasia.
5. Subject is willing and has an understanding and ability to fully comply with study procedures and restrictions defined in this protocol.

Exclusion Criteria:

1. Subject has any condition or abnormality, current or past that, in the opinion of the principal investigator, would compromise the safety of the subject or interfere with or complicate the assessment of signs or symptoms of achalasia. Such conditions may include psychiatric problems; neurologic deficits or disease; developmental delay; lung transplant; or previous gastroesophageal surgery.
2. Subject has had previous pneumatic dilation of treatment of achalasia.
3. Subject has had botulinum toxin (botox) injection for treatment of achalasia.
4. Subject has a history or high risk of noncompliance with treatment or regular clinic visits.

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Pneumatic Dilation; Subject with achalasia undergoing routine care EGD (Esophagogastroduodenoscopy) with pneumatic dilation	Procedure: pneumatic dilation; Pneumatic 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.
Surgical Myotomy; Subject with achalasia undergoing routine care EGD with surgical myotomy	Procedure: surgical myotomy; This procedure destroys the muscles at the gastroesophageal junction, allowing the valve (LES) between the esophagus and stomach to remain open.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Body weight	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 determine if differences may be identified between those who lose weight and those who do not. Body weight will be monitored at study visits throughout the study.	One year

Collaborators and Investigators

• Sponsor: Vanderbilt University Medical Center
• Investigators: Principal Investigator: Michael Vaezi, MD,PhD, Vanderbilt University Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): February 15, 2017
• Primary Completion (Anticipated): June 1, 2024
• Study Completion (Anticipated): June 1, 2024

Study Registration Dates

• First Submitted: February 21, 2017
• First Submitted That Met QC Criteria: February 21, 2017
• First Posted (Actual): February 24, 2017

Study Record Updates

• Last Update Posted (Estimate): May 11, 2023
• Last Update Submitted That Met QC Criteria: May 10, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Body Weight; Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Body Weight Changes; Weight Loss; Esophageal Achalasia
• Other Study ID Numbers: 161769

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No