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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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ClinicalTrials.gov Identifier: NCT01333436
Recruitment Status : Completed
First Posted : April 12, 2011
Results First Posted : April 9, 2013
Last Update Posted : May 5, 2017
Sponsor:
Information provided by (Responsible Party):

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.

Condition or disease Intervention/treatment
Dyslipidemia Hypercholesterolemia Other: Test Meal

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 93 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
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)
Actual Study Start Date : July 20, 2011
Primary Completion Date : May 12, 2012
Study Completion Date : May 12, 2012
Arms and Interventions

Arm Intervention/treatment
Experimental: Diabetic participants
Diabetic participants with normal to moderately high LDL-C
Other: 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.
Experimental: Nondiabetic participants
Non-diabetic participants with normal to moderately high LDL-C
Other: 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.


Outcome Measures

Primary Outcome Measures :
  1. Postprandial Incremental Area Under the Curve From 0-6 Hours (iAUC)[0-6] of Apolipoprotein B-48 (ApoB-48) [ Time Frame: 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 :
  1. Postprandial Mean ApoB-48 Peak Levels [ Time Frame: 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.

  2. Fasting ApoB-48 Levels [ Time Frame: Baseline (Hour 0) ]
    ApoB-48 levels measured after at least a 12-hour fast and prior to administration of test meal (Hour 0).


Eligibility Criteria

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01333436


Locations
Korea, Republic of
MSD Korea Ltd.
Seoul, Korea, Republic of, 121-705
Sponsors and Collaborators
Merck Sharp & Dohme Corp.
More Information

Publications:
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT01333436     History of Changes
Other Study ID Numbers: 0653A-259
First Posted: April 12, 2011    Key Record Dates
Results First Posted: April 9, 2013
Last Update Posted: May 5, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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


Additional relevant MeSH terms:
Hypercholesterolemia
Dyslipidemias
Hyperlipidemias
Lipid Metabolism Disorders
Metabolic Diseases