NCT00860392

Brief 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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at P25-P50 for phase_1 diabetes

Timeline
Completed

Started Mar 2009

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 2, 2009

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

March 11, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 12, 2009

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 8, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 8, 2009

Completed
Last Updated

November 27, 2017

Status Verified

November 1, 2017

Enrollment Period

4 months

First QC Date

March 11, 2009

Last Update Submit

November 23, 2017

Conditions

Diabetes

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • 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

Study Arms (1)

1

EXPERIMENTAL

Biomarker evaluation

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

Interventions

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.

1

Eligibility Criteria

Age18 Years - 55 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Medical Monitor

    Merck Sharp & Dohme LLC

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 11, 2009

First Posted

March 12, 2009

Study Start

March 2, 2009

Primary Completion

July 8, 2009

Study Completion

July 8, 2009

Last Updated

November 27, 2017

Record last verified: 2017-11