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A Comparison of Measurements of Ketone Body Flux Versus Ketone Body Concentration as a Pharmacodynamic Marker of Hepatic Fatty Acid Oxidation (0000-110)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00860392
First Posted: March 12, 2009
Last Update Posted: November 27, 2017
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. Read our disclaimer for details.
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
March 11, 2009
March 12, 2009
November 27, 2017
March 2, 2009
July 8, 2009   (Final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00860392 on ClinicalTrials.gov Archive Site
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 ]
Same as current
Not Provided
Not Provided
 
A Comparison of Measurements of Ketone Body Flux Versus Ketone Body Concentration as a Pharmacodynamic Marker of Hepatic Fatty Acid Oxidation (0000-110)
A Comparison of Measurements of Ketone Body Flux Versus Ketone Body Concentration as a Pharmacodynamic Marker of Hepatic Fatty Acid Oxidation
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.
Not Provided
Interventional
Phase 1
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Diabetes
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.
Experimental: 1
Biomarker evaluation
Intervention: Drug: Stable isotope tracer (13-C(4)-BHB)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
24
July 8, 2009
July 8, 2009   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: Male
18 Years to 55 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
Not Provided
Belgium
 
NCT00860392
0000-110
2009_560
No
Not Provided
Not Provided
Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
Not Provided
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
November 2017

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