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 Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT01333436
First received: March 24, 2011
Last updated: May 12, 2014
Last verified: May 2014
  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:


Further study details as provided by Merck Sharp & Dohme Corp.:

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 Sharp & Dohme Corp.
  More Information

No publications provided

Responsible Party: Merck Sharp & Dohme Corp.
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 12, 2014
Health Authority: Korea: Institutional Review Board

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

ClinicalTrials.gov processed this record on July 31, 2014