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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
Baylor Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Weight Loss

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

First Posted
July 12, 2017
Last Updated
July 29, 2020
Sponsor
Baylor Research Institute
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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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