Lipid MetabolismNCT02065817
Dose of Labeled Cholesterol for Kinetics: A Pilot Study
A study testing stable isotope of cholesterol in people with Lipid Metabolism, run by Mayo Clinic at 1 site in United States.
Trial summary
This is a pilot study to determine the optimum time and dose to draw blood samples using a tracer for HDL kinetics. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Lipid Metabolism
- What is being tested?
- stable isotope of cholesterol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2014to Dec 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy men and women ages 18 - 50
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
About this study
Official title: Dose of Labeled Cholesterol and Phenylalanine for HDL Kinetics: A Pilot Study
This is a pilot study to determine the optimum time and dose to draw blood samples using a tracer for HDL kinetics.
- Conditions
- Lipid Metabolism
- Being tested
- stable isotope of cholesterol
- Keywords
- Lipid, Apolipoproteins, Cardiovascular disease risks
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
stable isotope of cholesterolOther
| Study group | Role | What they receive |
|---|---|---|
| Tracer | Experimental | Not described Receives: Other: stable isotope of cholesterol |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2014 (estimated)
- Study startFeb 2014
- Primary completionNov 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lipid MetabolismStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ananda Basu, Mayo Clinic
- Investigators
- John M Miles, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02065817
- Sponsor's protocol ID
- 13-004890
- Status last verified
- Jan 2016
- First submitted
- 13 Feb 2014
- Last updated
- 7 Jan 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dose of Labeled Cholesterol and Phenylalanine for HDL Kinetics: A Pilot Study
- ClinicalTrials.gov ID
- NCT02065817
- Acronym / sponsor ID
- 13-004890
- Conditions
- Lipid Metabolism
- Keywords
- Lipid, Apolipoproteins, Cardiovascular disease risks
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- Feb 2014
- Primary completion
- Nov 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 19 Feb 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a pilot study to determine the optimum time and dose to draw blood samples using a tracer for HDL kinetics.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Tracer | Experimental | Other: stable isotope of cholesterol |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Healthy men and women ages 18 - 50
Key exclusion criteria (6 listed)
- Cardiovascular disease
- Metabolic disease
- Hematologic disorder
- Liver or kidney disease
- phenylketonuria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| stable isotope of cholesterol | Other | Tracer |
Primary outcome
Incorporation of orally administered 13C3 cholesterol into plasma cholesterol
Time frame: 72 hours
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jan 2016.
Related trials for Lipid Metabolism
RecruitingObservational study
Asprosin and miRNA Expression in Young Women With Metabolic Syndrome
Metabolic Syndrome, Insulin Resistance
RecruitingPhase 2
A Study of Solbinsiran (LY3561774) in Participants With Severe Hypertriglyceridemia
Severe Hypertriglyceridemia
Active, not recruitingPhase 1/2
Gene Transfer Clinical Trial for Infantile and Late Infantile Krabbe Disease Treated Previously With HSCT
Krabbe Disease
Not yet recruiting
Multimodal AI-Driven Out-of-Hospital Management for Hypertension and Cardiometabolic Risk
Hypertension, Hyperglycemia
RecruitingObservational study
Clinical and Neuropsychological Investigations in Batten Disease
Neuronal Ceroid Lipofuscinosis, Neuronal Ceroid Lipofuscinosis CLN1
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John M Miles, MD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing stable isotope of cholesterol in people with Lipid Metabolism, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incorporation of orally administered 13C3 cholesterol into plasma cholesterol (time frame: 72 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jan 2016.