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)

Not Applicable

Completed

• Conditions: Dyslipidemia; Hypercholesterolemia
• Interventions: Other: Test Meal

• Registration Number: NCT01333436
• Lead Sponsor: Organon and Co

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-03-24
• Study First Submitted QC: 2011-04-08
• Study First Posted: 2011-04-12
• Study Start: 2011-07-20
• Primary Completion: 2012-05-12
• Study Completion: 2012-05-12
• Results First Submitted: 2013-02-27
• Results First Submitted QC: 2013-02-27
• Results First Posted: 2013-04-09
• Status Verified: 2022-02
• Last Update Submitted: 2024-05-08
• Last Update Posted: 2024-05-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 93

Inclusion Criteria

Not provided

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Nondiabetic participants	Test Meal	Non-diabetic participants with normal to moderately high LDL-C
Diabetic participants	Test Meal	Diabetic participants with normal to moderately high LDL-C

Primary Outcome Measures

Name	Time	Method
Postprandial Incremental Area Under the Curve From 0-6 Hours (iAUC)[0-6] of Apolipoprotein B-48 (ApoB-48)	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.

Secondary Outcome Measures

Name	Time	Method
Fasting ApoB-48 Levels	Baseline (Hour 0)	ApoB-48 levels measured after at least a 12-hour fast and prior to administration of test meal (Hour 0).
Postprandial Mean ApoB-48 Peak Levels	up to 6 hours after Test Meal	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.

Trial Locations

Locations (1)

MSD Korea Ltd.; 🇰🇷 Seoul, Korea, Republic of