Ignite Creation Date:
2025-12-24 @ 7:36 PM
Ignite Modification Date:
2026-01-05 @ 5:17 PM
Study NCT ID:
NCT03035903
Status:
COMPLETED
Last Update Posted:
2018-06-06
First Post:
2017-01-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Energy Cost for Holding a MedGem® Indirect Calorimeter
Sponsor:
Pennington Biomedical Research Center
Organization:
Study Overview
Official Title:
Energy Cost for Holding a MedGem® Indirect Calorimeter
Status:
COMPLETED
Status Verified Date:
2018-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
MEDGEM
Brief Summary:
The goal of this clinical protocol is to perform a randomized crossover study to determine the energy cost of holding the MedGem® device above a person's normal resting metabolic rate (RMR) compared to not holding the MedGem® device.
Detailed Description:
Forty (40) subjects will be randomized to two (2) RMR measurements separated by a 40-minute rest (washout) period. The two RMR evaluation periods are as follows:
1. RMR with MedGem® Indirect Calorimeter
2. RMR without MedGem® Indirect Calorimeter
Study recruitment will be performed at PBRC. Screening, consenting, and all study procedures will be performed within a single study visit at PBRC within the Inpatient Unit. All subjects will be introduced to the ventilated hood to determine presence of claustrophobia prior to enrollment (i.e., signing of the consent form).
1. RMR with MedGem® Indirect Calorimeter
2. RMR without MedGem® Indirect Calorimeter
Study recruitment will be performed at PBRC. Screening, consenting, and all study procedures will be performed within a single study visit at PBRC within the Inpatient Unit. All subjects will be introduced to the ventilated hood to determine presence of claustrophobia prior to enrollment (i.e., signing of the consent form).
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: