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Resting Metabolic Rate Testing in Bariatric Surgery Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03221543
Recruitment Status : Recruiting
First Posted : July 18, 2017
Last Update Posted : August 2, 2017
Sponsor:
Information provided by (Responsible Party):
Baylor Research Institute

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.

Condition or disease Intervention/treatment Phase
Weight Loss Bariatric Surgery Candidate Device: ReeVue Indirect Calorimeter Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Role of Pre-Surgical Metabolic Testing for Procedure Selection in Bariatric Surgery
Actual Study Start Date : July 31, 2017
Estimated Primary Completion Date : August 1, 2022
Estimated Study Completion Date : December 1, 2027

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Resting Metabolic Rate Testing
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.
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.




Primary Outcome Measures :
  1. Examine percent total weight loss [ Time Frame: 1 year ]
    Weigh subjects using a scale


Secondary Outcome Measures :
  1. Change in resting metabolic rate [ Time Frame: 1 year ]
    Obtain resting metabolic rate using the Reevue Indirect Calorimeter



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • All patients scheduled for a primary bariatric surgery
  • 18 years of age to no upper limit

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): NCT03221543


Locations
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United States, Texas
Baylor Weight Loss Surgery Center Recruiting
Dallas, Texas, United States, 75231
Contact: Estrellita Ontiveros, MA    214-820-5283    estrellita.ontiveros@bswhealth.org   
Principal Investigator: Daniel Davis, DO         
Sponsors and Collaborators
Baylor Research Institute

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Responsible Party: Baylor Research Institute
ClinicalTrials.gov Identifier: NCT03221543    
Other Study ID Numbers: IRB 017-125
First Posted: July 18, 2017    Key Record Dates
Last Update Posted: August 2, 2017
Last Verified: August 2017

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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
Additional relevant MeSH terms:
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Weight Loss
Body Weight Changes
Body Weight
Signs and Symptoms