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 Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

93 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-07-20

Study Completion Date

2012-05-12

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.

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Detailed Description

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Conditions

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Dyslipidemia Hypercholesterolemia

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Diabetic participants

Diabetic participants with normal to moderately high LDL-C

Group Type EXPERIMENTAL

Test Meal

Intervention Type OTHER

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.

Nondiabetic participants

Non-diabetic participants with normal to moderately high LDL-C

Group Type EXPERIMENTAL

Test Meal

Intervention Type OTHER

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.

Interventions

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Test Meal

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.

Intervention Type OTHER

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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes