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Trial record 14 of 24 for:    Recruiting, Not yet recruiting, Available Studies | "Esophageal Achalasia"

Mechanisms of Weight Loss in Patients Diagnosed With Achalasia

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ClinicalTrials.gov Identifier: NCT03063463
Recruitment Status : Recruiting
First Posted : February 24, 2017
Last Update Posted : June 19, 2018
Sponsor:
Information provided by (Responsible Party):
Michael Vaezi, Vanderbilt University Medical Center

Brief 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.

Condition or disease Intervention/treatment
Achalasia 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
Estimated Enrollment : 50 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Mechanisms of Weight Loss in Patients Diagnosed With Achalasia: A Prospective Observational Study
Actual Study Start Date : February 15, 2017
Estimated Primary Completion Date : February 2019
Estimated Study Completion Date : February 2020

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. Body weight [ Time Frame: One year ]
    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.


Biospecimen Retention:   Samples With DNA
Serum sample will be collected for future genomic analysis.


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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 as part of their routine care.
Criteria

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 18-70 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03063463


Contacts
Contact: Amy Motley 615-322-6281 amy.motley@vanderbilt.edu
Contact: Tina Higginbotham 615-322-4643 tina.higginbotham@vanderbilt.edu

Locations
United States, Tennessee
Vanderbilt University Medical Center Recruiting
Nashville, Tennessee, United States, 37212
Contact: Amy Motley    615-322-6281    amy.motley@vanderbilt.edu   
Contact: Tina Higginbotham    615-322-4643    tina.higginbotham@vanderbilt.edu   
Principal Investigator: Michael Vaezi, MD, PhD         
Sponsors and Collaborators
Vanderbilt University Medical Center
Investigators
Principal Investigator: Michael Vaezi, MD,PhD Vanderbilt University Medical Center

Responsible Party: Michael Vaezi, Principal Investigator, Vanderbilt University Medical Center
ClinicalTrials.gov Identifier: NCT03063463     History of Changes
Other Study ID Numbers: 161769
First Posted: February 24, 2017    Key Record Dates
Last Update Posted: June 19, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Weight Loss
Esophageal Achalasia
Body Weight Changes
Body Weight
Signs and Symptoms
Esophageal Motility Disorders
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases