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 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.

Completed

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Key information

Conditions

Diabetes Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–55 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Stable isotope tracer (13-C(4)-BHB)

Drug

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.

Primary outcomes

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

Secondary outcomes

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

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study title

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

Important dates

Study start: 2009
Primary completion: 2009
Study completion: 2009
First posted: Mar 12, 2009
Registry last updated: Nov 27, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed