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

Diabetes Clinical Trial

Official title:

A Comparison of Measurements of Ketone Body Flux Versus Ketone Body Concentration as a Pharmacodynamic Marker of Hepatic Fatty Acid Oxidation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00860392
• Other study ID #: 0000-110
• Secondary ID: 2009_560
• Status: Completed
• Phase: Phase 1
• First received: March 11, 2009
• Last updated: November 23, 2017
• Start date: March 2, 2009
• Est. completion date: July 8, 2009

Study information

• Verified date: November 2017
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: July 8, 2009
• Est. primary completion date: July 8, 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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		5 hours
Secondary	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		5 hours