Mechanisms of Weight Loss in Patients Diagnosed With Achalasia



Status:Recruiting
Conditions:Gastrointestinal
Therapuetic Areas:Gastroenterology
Healthy:No
Age Range:18 - 75
Updated:3/28/2019
Start Date:February 15, 2017
End Date:June 2020
Contact:Amy Motley
Email:amy.motley@vumc.org
Phone:615-322-6281

Use our guide to learn which trials are right for you!

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.

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.

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.
We found this trial at
1
site
1211 Medical Center Dr
Nashville, Tennessee 37232
(615) 322-5000
Principal Investigator: Michael Vaezi, MD, PhD
Phone: 615-322-6281
Vanderbilt Univ Med Ctr Vanderbilt University Medical Center (VUMC) is a comprehensive healthcare facility dedicated...
?
mi
from
Nashville, TN
Click here to add this to my saved trials