Validation of the Quark RMR Calorimeter (Cosmed) Versus D... | NCT00848471

Studies
Validation of the Quark RMR Calorimeter (Cosmed) Versus Deltatrac II (GE Health Care Clinical Systems)

NCT00848471

Sponsor

Hospices Civils de Lyon

Status

Unknown status

Last Update Posted

Aug 19, 2009Estimated

Enrollment

30Estimated

Phase

Not Applicable

Conditions

Healthy
Obesity

Interventions

Quark RMR
Deltatrac II

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2009

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2009

Primary Completion Date

Dec 2009Estimated

Completion Date

Dec 2009Estimated

First Submitted Date

Feb 19, 2009

First Submission Date that Met QC Criteria

Feb 19, 2009

First Posted Date

Feb 20, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 18, 2009

Last Update Posted Date

Aug 19, 2009Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Not provided

Lead Sponsor

Hospices Civils de LyonOTHER

Collaborators

Name	Class
Centre de Recherche en Nutrition Humaine Rhone-Alpe	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Measurement of energy expenditure at rest (12 hours fasting) and in dynamic phase after a meal (600kcal) to compare the results of the two calorimeters in standardized conditions for the validation of quark RMR versus Deltatrac II

Detailed Description

Clinically, energy expenditure is usually estimated using predictive equations, such as the Harris-Benedict equation, which consider the patient's weight, height, age and sex to determine energy needs. However these have been shown to be unsystematically incorrect and may vary by 70-140% when compared with indirect and direct calorimetry measurements.

That is why the most popular method of measurement of energy expenditure in research is via indirect calorimetry using a metabolic cart. Indirect calorimetry is the measurement of the volume of oxygen consumption and carbon dioxide production.

Actually, there are few numbers of indirect calorimeters available commercialy. The Deltatrac II metabolic cart was the gold standard. It has been extensively used in clinical research both for resting metabolic rate and substrate oxidation measurement during postprandial or an insulin clamp. The Quark RMR is also a metabolic cart too which was launched on the market to compete with the others calorimeters measuring resting metabolic rate.

As the Quark RMR and Deltatrac II use the same measure device (paramagnetic analyser for oxygen detection, infrared absorption for carbon dioxide detection) with the same sensitivity and time response according to constructor's data, we want to compare these two calorimeters for the measurement of energy expenditure and substrate oxidation at rest and during a meal in standardized conditions.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

30Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Experimental	Quark RMR calorimeter (Cosmed)	Device: Quark RMR
2	Active Comparator	Deltatrac II (GE health Care Clinical Systems)	Device: Deltatrac II

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Quark RMR	Device	Quark RMR calorimeter (Cosmed)	1
Deltatrac II

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
To compare the results obtained for the Deltatrac II and the Quark RMR for the measure of energy expenditure at rest in standardized conditions		At the end of the study

Secondary Outcomes

Measure	Description	Time Frame
To compare the results obtained for the Deltatrac II and the Quark RMR for the measure of energy expenditure after a food intake of 600kcal		At the end of the study

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

18 to 60 years old
BMI between 20 and 35 kg/m²
Weight stable for at least 2 months
Safety subject during medical consultation
Normal TSH -CRP -glycemia - creatinin

Exclusion Criteria:

Medical or surgical history which may affect energy expenditure (renal -cardiovascular -hepatic- endocrine-inflamatory diseases)
Drug use that could affect energy expenditure (steroids, nicotine substitutes, thyroid hormones)
Eating disorder
Intensive sportive activity (Baecke's score >5)
Subjects who Smoke
Claustrophobic subjects
Pregnant women

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

60 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Secretary, Centre de Recherche en Nutrition Rhône Alpes	Contact	04.72.11.07.08		secretariat.crnh@chu-lyon.fr

Overall Officials

Name	Affiliation	Role
Martine LAVILLE, M.D	Hôpital Edouard Herriot	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Centre de Recherche en Nutrition Rhône Alpes, Hôpital Edouard Herriot	Recruiting	Lyon	Rhone-Alps	69424	France

Condition Browse Module

MeSH Terms

ID	Term
D009765	Obesity

Ancestor Terms

ID	Term
D050177	Overweight
D044343	Overnutrition
D009748	Nutrition Disorders
D009750	Nutritional and Metabolic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided