Resting Metabolic Rate Testing in Bariatric Surgery Patients
Primary Purpose
Weight Loss, Bariatric Surgery Candidate
Status
Enrolling by invitation
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
ReeVue Indirect Calorimeter
Sponsored by
About this trial
This is an interventional treatment trial for Weight Loss
Eligibility Criteria
Inclusion Criteria:
- All patients scheduled for a primary bariatric surgery
- 18 years of age to no upper limit
Sites / Locations
- Baylor Weight Loss Surgery Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Resting Metabolic Rate Testing
Arm Description
All subjects will have the resting metabolic rate test. The ReeVue Indirect Calorimeter from Korr Medical will be used to obtain the resting metabolic rate.
Outcomes
Primary Outcome Measures
Examine percent total weight loss
Weigh subjects using a scale
Secondary Outcome Measures
Change in resting metabolic rate
Obtain resting metabolic rate using the Reevue Indirect Calorimeter
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03221543
Brief Title
Resting Metabolic Rate Testing in Bariatric Surgery Patients
Official Title
The Role of Pre-Surgical Metabolic Testing for Procedure Selection in Bariatric Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
June 2020
Overall Recruitment Status
Enrolling by invitation
Study Start Date
July 31, 2017 (Actual)
Primary Completion Date
August 1, 2022 (Anticipated)
Study Completion Date
December 1, 2027 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Baylor Research Institute
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
Detailed 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Weight Loss, Bariatric Surgery Candidate
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Resting Metabolic Rate Testing
Arm Type
Experimental
Arm Description
All subjects will have the resting metabolic rate test. The ReeVue Indirect Calorimeter from Korr Medical will be used to obtain the resting metabolic rate.
Intervention Type
Device
Intervention Name(s)
ReeVue Indirect Calorimeter
Intervention Description
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.
Primary Outcome Measure Information:
Title
Examine percent total weight loss
Description
Weigh subjects using a scale
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Change in resting metabolic rate
Description
Obtain resting metabolic rate using the Reevue Indirect Calorimeter
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
All patients scheduled for a primary bariatric surgery
18 years of age to no upper limit
Facility Information:
Facility Name
Baylor Weight Loss Surgery Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
12. IPD Sharing Statement
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Resting Metabolic Rate Testing in Bariatric Surgery Patients
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