DyslipidemiaNCT01333436
A Study to Evaluate Fasting/Postprandial Serum Apolipoprotein B-48 (ApoB-48) Levels in Diabetic Participants With Normal to Moderately High Low Density Lipoprotein-C (LDL-C) Levels (MK-0653A-259 AM1)
A study testing Test Meal in people with Dyslipidemia and Hypercholesterolemia, run by Organon and Co at 1 site in South Korea.
Trial summary
This study will evaluate whether fasting/postprandial serum ApoB-48 levels are increased in diabetic participants compared to nondiabetic participants with the same range of serum LDL-C levels, and whether ApoB-48 levels can be used, along with LDL-C levels, to identify potential cardiovascular disease risk. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Dyslipidemia, Hypercholesterolemia
- What is being tested?
- Test Meal
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 93 participants
- Where
- 1 siteSouth Korea
- Study dates
- 20 Jul 2011to 12 May 2012
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Participant has an LDL-C ranging from ≥100 mg/dL to <160 mg/dL.
- Patient has a triglyceride (TG) level of ≤500 mg/dL.
Who cannot join
- Participant treated with a lipid-lowering agent in the 6 weeks prior to Visit 1 (screening period).
- Participant has active liver disease or persistent unexplained serum transaminase elevations (≥2 x the upper limit of normal [ULN])
- Participant has increased creatine kinase (CK) (≥2 x ULN).
- Participant has a history of type 1 diabetes mellitus, ketoacidosis, or gestational diabetes mellitus.
- Participant has a history of alcohol and/or drug abuse.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Multicenter, Cross-sectional Study to Evaluate Plasma ApoB-48 Concentration Among Korean Diabetic Patients (With Normal to Moderately High LDL-C Levels)
This study will evaluate whether fasting/postprandial serum ApoB-48 levels are increased in diabetic participants compared to nondiabetic participants with the same range of serum LDL-C levels, and whether ApoB-48 levels can be used, along with LDL-C levels, to identify potential cardiovascular disease risk.
- Conditions
- Dyslipidemia, Hypercholesterolemia
- Being tested
- Test Meal
- Medical subject headings
- Dyslipidemias, Hypercholesterolemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Test MealOther
During Visit 2, a test meal will be supplied by the Sponsor of approximately 944 kcal (57% fat, 31% carbohydrate, and 12% protein), and postprandial blood draws will be done at 1, 2, 3, 4, and 6 hours after the meal.
| Study group | Role | What they receive |
|---|---|---|
| Diabetic participants | Experimental | Diabetic participants with normal to moderately high LDL-C Receives: Other: Test Meal |
| Nondiabetic participants | Experimental | Non-diabetic participants with normal to moderately high LDL-C Receives: Other: Test Meal |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postprandial Incremental Area Under the Curve From 0-6 Hours (iAUC)[0-6] of Apolipoprotein B-48 (ApoB-48)
ApoB-48 levels were measured at 1, 2, 3, 4, and 6 hours after the administration of the test meal.
Measured: up to 6 hours after Test Meal
Secondary outcomes (2)
Postprandial Mean ApoB-48 Peak Levels
ApoB-48 levels measured at 1, 2, 3, 4, and 6 hours after the administration of test meal. Peak was the highest ApoB-48 level recorded during this timeframe.
Measured: up to 6 hours after Test Meal
Fasting ApoB-48 Levels
ApoB-48 levels measured after at least a 12-hour fast and prior to administration of test meal (Hour 0).
Measured: Baseline (Hour 0)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2011 (estimated)
- Study start20 Jul 2011
- Primary completion12 May 2012
- Study completion12 May 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DyslipidemiaStudies of the same condition, open and under way.
- 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
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 93 participants (actual)
Sponsor and investigators
- Lead sponsor
- Organon and Co
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01333436
- Sponsor's protocol ID
- 0653A-259
- Status last verified
- Feb 2022
- First submitted
- 24 Mar 2011
- Last updated
- 13 May 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Park CY, Park JY, Choi J, Kim DJ, Park KS, Yoon KH, Lee MK, Park SW. Increased postprandial apolipoprotein B-48 level after a test meal in diabetic patients: A multicenter, cross-sectional study. Metabolism. 2016 Jun;65(6):843-51. doi: 10.1016/j.metabol.2016.02.008. Epub 2016 Feb 23.
PubMed 27173463
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Cross-sectional Study to Evaluate Plasma ApoB-48 Concentration Among Korean Diabetic Patients (With Normal to Moderately High LDL-C Levels)
- ClinicalTrials.gov ID
- NCT01333436
- Acronym / sponsor ID
- 0653A-259
- Conditions
- Dyslipidemia, Hypercholesterolemia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 93 participants (actual)
- Lead sponsor
- Organon and CoIndustry (pharma, biotech, devices)
- Study start
- 20 Jul 2011 (actual)
- Primary completion
- 12 May 2012 (actual)
- Study completion
- 12 May 2012 (actual)
- First posted
- 12 Apr 2011 (estimated)
- Results
- Posted 9 Apr 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will evaluate whether fasting/postprandial serum ApoB-48 levels are increased in diabetic participants compared to nondiabetic participants with the same range of serum LDL-C levels, and whether ApoB-48 levels can be used, along with LDL-C levels, to identify potential cardiovascular disease risk.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Diabetic participants | Experimental | Other: Test MealDiabetic participants with normal to moderately high LDL-C |
| Nondiabetic participants | Experimental | Other: Test MealNon-diabetic participants with normal to moderately high LDL-C |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Participant has an LDL-C ranging from ≥100 mg/dL to <160 mg/dL.
- Patient has a triglyceride (TG) level of ≤500 mg/dL.
Key exclusion criteria (5 listed)
- Participant treated with a lipid-lowering agent in the 6 weeks prior to Visit 1 (screening period).
- Participant has active liver disease or persistent unexplained serum transaminase elevations (≥2 x the upper limit of normal [ULN])
- Participant has increased creatine kinase (CK) (≥2 x ULN).
- Participant has a history of type 1 diabetes mellitus, ketoacidosis, or gestational diabetes mellitus.
- Participant has a history of alcohol and/or drug abuse.
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 |
|---|---|---|
| Test MealDuring Visit 2, a test meal will be supplied by the Sponsor of approximately 944 kcal (57% fat, 31% carbohydrate, and 12% protein), and postprandial blood draws will be done at 1, 2, 3, 4, and 6 hours after the meal. | Other | Diabetic participants, Nondiabetic participants |
Primary outcome
Postprandial Incremental Area Under the Curve From 0-6 Hours (iAUC)[0-6] of Apolipoprotein B-48 (ApoB-48)
Time frame: up to 6 hours after Test Meal
ApoB-48 levels were measured at 1, 2, 3, 4, and 6 hours after the administration of the test meal.
2 secondary outcomes
Postprandial Mean ApoB-48 Peak Levels
Time frame: up to 6 hours after Test Meal
Fasting ApoB-48 Levels
Time frame: Baseline (Hour 0)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 27173463Park CY, Park JY, Choi J, Kim DJ, Park KS, Yoon KH, Lee MK, Park SW. Increased postprandial apolipoprotein B-48 level after a test meal in diabetic patients: A multicenter, cross-sectional study. Metabolism. 2016 Jun;65(6):843-51. doi: 10.1016/j.metabol.2016.02.008. Epub 2016 Feb 23.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Test Meal in people with Dyslipidemia and Hypercholesterolemia, run by Organon and Co at 1 site in South Korea.
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 2 inclusion and 5 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 13 May 2024. 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 South Korea. 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?
Yes. Results are posted in the registry (first posted 9 Apr 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Postprandial Incremental Area Under the Curve From 0-6 Hours (iAUC)[0-6] of Apolipoprotein B-48 (ApoB-48) (time frame: up to 6 hours after Test Meal). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01333436, which also lists 1 linked publication.
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 13 May 2024.