NCT02065817

Brief Summary

This is a pilot study to determine the optimum time and dose to draw blood samples using a tracer for HDL kinetics.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
7

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2014

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2014

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

February 13, 2014

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 19, 2014

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2015

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

January 7, 2016

Status Verified

January 1, 2016

Enrollment Period

1.7 years

First QC Date

February 13, 2014

Last Update Submit

January 5, 2016

Conditions

Lipid Metabolism

Keywords

LipidApolipoproteinsCardiovascular disease risks

Outcome Measures

Primary Outcomes (1)

  • Incorporation of orally administered 13C3 cholesterol into plasma cholesterol

    13C3 cholesterol, which is labeled with a stable isotope, will be administered orally. Blood samples will be taken every 4-6 hours for 72 hours for the measurement of stable isotopic enrichment in cholesterol using gas chromatography-mass spectrometry. The study has a dual purpose: to determine the optimum oral dose of isotope, and to determine the time of peak enrichment in plasma cholesterol.

    72 hours

Study Arms (1)

Tracer

EXPERIMENTAL
Other: stable isotope of cholesterol

Interventions

stable isotope of cholesterolOTHER
Tracer

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy men and women ages 18 - 50

You may not qualify if:

  • Cardiovascular disease
  • Metabolic disease
  • Hematologic disorder
  • Liver or kidney disease
  • phenylketonuria
  • Currently taking lipid lowering medications or any other drugs that could affect lipid metabolism

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

Study Officials

  • John M Miles, MD

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PI

Study Record Dates

First Submitted

February 13, 2014

First Posted

February 19, 2014

Study Start

February 1, 2014

Primary Completion

November 1, 2015

Study Completion

December 1, 2015

Last Updated

January 7, 2016

Record last verified: 2016-01

Locations

US(1)