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)

Study Overview
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Brief Summary
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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.

Official Title
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A Multicenter, Cross-sectional Study to Evaluate Plasma ApoB-48 Concentration Among Korean Diabetic Patients (With Normal to Moderately High LDL-C Levels)

Conditions
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Dyslipidemia, Hypercholesterolemia

Intervention / Treatment
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* Other: Test Meal


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Diabetic participants<br>Diabetic participants with normal to moderately high LDL-C | Other: Test Meal<br>* 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.<br>|
| Experimental: Nondiabetic participants<br>Non-diabetic participants with normal to moderately high LDL-C | Other: Test Meal<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | up to 6 hours after Test Meal | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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). | Baseline (Hour 0) |