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NCT03221543 Clinical Trial

Resting Metabolic Rate Testing in Bariatric Surgery Patients

Weight Loss Clinical Trial

Official title:
The Role of Pre-Surgical Metabolic Testing for Procedure Selection in Bariatric Surgery

Clinical Trial Details — Status: Enrolling by invitation

Administrative data
NCT number NCT03221543
Other study ID # IRB 017-125
Secondary ID
Status Enrolling by invitation
Phase N/A
First received
Last updated
Start date July 31, 2017
Est. completion date December 1, 2027

Study information
Verified date June 2020
Source Baylor Research Institute
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study evaluates if measuring resting metabolic rate (the number of calories the body burns at rest) before surgery can help predict successful weight loss after surgery.

Description:

This is a prospective study enrolling patients from the Baylor Weight Loss Surgery Center who have met all of the requirements to proceed with primary bariatric surgery. Patients will undergo pre-operative and post-operative metabolic testing (6 months, and 1 year after surgery) using a portable calorimeter with eventual follow up of medical record at 5 years. Data from up to 50 patients will be collected. The main objectives are to examine if the pre-operative resting metabolic rate can accurately predict successful weight loss after bariatric surgery and if it can be used to guide the selection of the type of bariatric surgery that would be most successful for the patient.

Recruitment information / eligibility
Status Enrolling by invitation
Enrollment 50
Est. completion date December 1, 2027
Est. primary completion date August 1, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- All patients scheduled for a primary bariatric surgery

- 18 years of age to no upper limit

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• ReeVue Indirect Calorimeter
The ReeVue Indirect Calorimeter will be used in this study to measure the resting metabolic rate. The test takes approximately ten minutes to complete. The subject should prepare for the test by avoiding stimulants and exercise on the day of the test, as well as eating meals four hours before the test. The subject will be seated during the test. They will be given a nose clip that looks like a clothes pin to be placed on their nose. A plastic mouth piece that allows all of the air they breathe to come in through the top of the mouth piece and the air they breathe out to go into the ReeVue Calorimeter will also be provided. The subject will remain in this position for ten minutes until the testing is complete.

Locations
Country Name City State
United States Baylor Weight Loss Surgery Center Dallas Texas

Sponsors (1)
Lead Sponsor Collaborator
Baylor Research Institute

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Examine percent total weight loss Weigh subjects using a scale 1 year
Secondary Change in resting metabolic rate Obtain resting metabolic rate using the Reevue Indirect Calorimeter 1 year
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