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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)

NCT ID: NCT00860392

Last Updated: 2017-11-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-03-02

Study Completion Date

2009-07-08

Brief Summary

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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.

Detailed Description

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Conditions

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Diabetes

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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1

Biomarker evaluation

Group Type EXPERIMENTAL

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

Intervention Type 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.

Interventions

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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.

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Medical Monitor

Role: STUDY_DIRECTOR

Merck Sharp & Dohme LLC

Countries

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Belgium

Other Identifiers

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2009_560

Identifier Type: -

Identifier Source: secondary_id

0000-110

Identifier Type: -

Identifier Source: org_study_id