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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)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck
ClinicalTrials.gov Identifier:
NCT01333436
First received: March 24, 2011
Last updated: May 7, 2013
Last verified: May 2013
History of Changes
  Purpose

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 Intervention
Dyslipidemia
Hypercholesterolemia
 Other: Test Meal

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: 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)

Resource links provided by NLM:

MedlinePlus related topics: Cholesterol
U.S. FDA Resources

Further study details as provided by Merck:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    ApoB-48 levels were measured at 1, 2, 3, 4, and 6 hours after the administration of the test meal.


Secondary Outcome Measures:
  • Postprandial Mean ApoB-48 Peak Levels [ Time Frame: up to 6 hours after Test Meal ] [ Designated as safety issue: No ]
    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.

  • Fasting ApoB-48 Levels [ Time Frame: Baseline (Hour 0) ] [ Designated as safety issue: No ]
    ApoB-48 levels measured after at least a 12-hour fast and prior to administration of test meal (Hour 0).


Enrollment: 93
Study Start Date: July 2011
Study Completion Date: May 2012
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01333436

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

No publications provided

Responsible Party: Merck
ClinicalTrials.gov Identifier: NCT01333436     History of Changes
Other Study ID Numbers: 0653A-259
Study First Received: March 24, 2011
Results First Received: February 27, 2013
Last Updated: May 7, 2013
Health Authority: Korea: Institutional Review Board

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

ClinicalTrials.gov processed this record on May 19, 2013