A Comparison of Two Methods of Measuring Hepatic Fatty Acid Oxidation - Full Text View

Sponsored by:	Merck
Information provided by:	Merck
ClinicalTrials.gov Identifier:	NCT00860392

Purpose

This study will compare two approaches to the measurement of fatty acid oxidation (ketone body flux and ketone body concentration) and determine which method demonstrates superior sensitivity and variability in the detection of moderate increases in ketogenesis rates.

Condition	Intervention	Phase
Diabetes	Drug: Stable isotope tracer (13-C(4)-BHB)	Phase I

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Diagnostic, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Pharmacodynamics Study
Official Title:	A Comparison of Measurements of Ketone Body Flux Versus Ketone Body Concentration as a Pharmacodynamic Marker of Hepatic Fatty Acid Oxidation

Further study details as provided by Merck:

Primary Outcome Measures:

Effects of increase in serum free fatty acid levels on ketogenesis as measured using a isotopic tracer and serum ketone body concentration in healthy lean subjects [ Time Frame: 5 hours ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Effects of increase in serum free fatty acid levels on ketogenesis as measured using a isotopic tracer and serum ketone body concentration in obese subjects [ Time Frame: 5 hours ] [ Designated as safety issue: No ]

Estimated Enrollment:	16
Study Start Date:	March 2009
Estimated Study Completion Date:	June 2009
Estimated Primary Completion Date:	May 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Biomarker evaluation	Drug: Stable isotope tracer (13-C(4)-BHB) A stable isotope tracer (13-C(4)-BHB), a commercially available lipid emulsion, and heparin will be administered intravenously. Ketone body concentrations will be measured before beginning the infusion, at approx. 135 minutes, and at approx. 255 minutes.

Eligibility

Ages Eligible for Study:	18 Years to 55 Years
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Subject has a Body Mass Index of 18-25 kg/m2 OR 29-40 kg/m2
Subject has been a nonsmoker or has not used nicotine for the past 6 months

Exclusion Criteria:

Subject has a history of diabetes mellitus
Subject has a history of stroke, chronic seizures, or other neurological disorder
Subject has a history of cancer, except certain skin cancers
Subject consumes more than 3 alcoholic beverages per day
Subject consumes more than 6 servings of caffeinated beverages per day
Subject has multiple and/or severe allergies to food or drugs
Subject has allergy or sensitivity to eggs or soy
Subject regularly uses illicit drugs or has a history of drug or alcohol abuse

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00860392

Locations

Belgium
Merck Sharp & Dohme B.V.	Recruiting
Bruxelles, Belgium, 1180
Contact: Nathalie Schrameijer 32-2-373-4310

Sponsors and Collaborators

Merck

Investigators

Study Director:

Medical Monitor

Merck

More Information

No publications provided

Responsible Party:	Merck & Co., Inc. ( Executive Vice President, Clinical and Quantitative Sciences )
Study ID Numbers:	2009_560, 110
Study First Received:	March 11, 2009
Last Updated:	April 1, 2009
ClinicalTrials.gov Identifier:	NCT00860392 History of Changes
Health Authority:	Belgium: Directorate general for the protection of Public health: Medicines

Study placed in the following topic categories:

Diabetes Mellitus
Heparin
Calcium heparin

ClinicalTrials.gov processed this record on May 07, 2009