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)

Organon and Co93 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

Conditions

Dyslipidemia Hypercholesterolemia

Interventions

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.

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

MSD Korea Ltd.

Seoul, South Korea

Outcomes

Primary Outcomes

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.

Time frame: up to 6 hours after Test Meal

Secondary Outcomes

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.

Time frame: 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).

Time frame: Baseline (Hour 0)

Data from ClinicalTrials.gov

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