Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

Tracking Information
First Submitted Date  ICMJE July 12, 2017
First Posted Date  ICMJE July 18, 2017
Last Update Posted Date August 2, 2017
Actual Study Start Date  ICMJE July 31, 2017
Estimated Primary Completion Date August 1, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 17, 2017)
Examine percent total weight loss [ Time Frame: 1 year ]
Weigh subjects using a scale
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 17, 2017)
Change in resting metabolic rate [ Time Frame: 1 year ]
Obtain resting metabolic rate using the Reevue Indirect Calorimeter
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Resting Metabolic Rate Testing in Bariatric Surgery Patients
Official Title  ICMJE The Role of Pre-Surgical Metabolic Testing for Procedure Selection in Bariatric Surgery
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Weight Loss
  • Bariatric Surgery Candidate
Intervention  ICMJE 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.
Study Arms  ICMJE 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.
Intervention: Device: ReeVue Indirect Calorimeter
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: July 17, 2017)
50
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 1, 2027
Estimated Primary Completion Date August 1, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • All patients scheduled for a primary bariatric surgery
  • 18 years of age to no upper limit
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03221543
Other Study ID Numbers  ICMJE IRB 017-125
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Baylor Research Institute
Study Sponsor  ICMJE Baylor Research Institute
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Baylor Research Institute
Verification Date August 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP