Back to resultsA 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)
Primary Purpose
Dyslipidemia, Hypercholesterolemia
Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Test Meal
Sponsored by
About this trial
This is an interventional diagnostic trial for Dyslipidemia
Eligibility Criteria
Inclusion criteria:
- Participant has an LDL-C ranging from ≥100 mg/dL to <160 mg/dL.
- Patient has a triglyceride (TG) level of ≤500 mg/dL.
Exclusion Criteria:
- 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.
Sites / Locations
- MSD Korea Ltd.
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Diabetic participants
Nondiabetic participants
Arm Description
Diabetic participants with normal to moderately high LDL-C
Non-diabetic participants with normal to moderately high LDL-C
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
Fasting ApoB-48 Levels
ApoB-48 levels measured after at least a 12-hour fast and prior to administration of test meal (Hour 0).
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01333436
Brief Title
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)
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)
Study Type
Interventional
2. Study Status
Record Verification Date
February 2022
Overall Recruitment Status
Completed
Study Start Date
July 20, 2011 (Actual)
Primary Completion Date
May 12, 2012 (Actual)
Study Completion Date
May 12, 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Organon and Co
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dyslipidemia, Hypercholesterolemia
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
93 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Diabetic participants
Arm Type
Experimental
Arm Description
Diabetic participants with normal to moderately high LDL-C
Arm Title
Nondiabetic participants
Arm Type
Experimental
Arm Description
Non-diabetic participants with normal to moderately high LDL-C
Intervention Type
Other
Intervention Name(s)
Test Meal
Intervention Description
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.
Primary Outcome Measure Information:
Title
Postprandial Incremental Area Under the Curve From 0-6 Hours (iAUC)[0-6] of Apolipoprotein B-48 (ApoB-48)
Description
ApoB-48 levels were measured at 1, 2, 3, 4, and 6 hours after the administration of the test meal.
Time Frame
up to 6 hours after Test Meal
Secondary Outcome Measure Information:
Title
Postprandial Mean ApoB-48 Peak Levels
Description
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.
Time Frame
up to 6 hours after Test Meal
Title
Fasting ApoB-48 Levels
Description
ApoB-48 levels measured after at least a 12-hour fast and prior to administration of test meal (Hour 0).
Time Frame
Baseline (Hour 0)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion criteria:
Participant has an LDL-C ranging from ≥100 mg/dL to <160 mg/dL.
Patient has a triglyceride (TG) level of ≤500 mg/dL.
Exclusion Criteria:
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.
Facility Information:
Facility Name
MSD Korea Ltd.
City
Seoul
ZIP/Postal Code
121-705
Country
Korea, Republic of
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
http://www.merck.com/clinical-trials/pdf/Merck%20Procedure%20on%20Clinical%20Trial%20Data%20Access%20Final_Updated%20July_9_2014.pdf
http://engagezone.msd.com/ds_documentation.php
Citations:
PubMed Identifier
27173463
Citation
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.
Results Reference
result
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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)
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