Skip to main content
OpenTrials
Completed

NCT Number: NCT01333436

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 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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Dyslipidemia Dyslipidemias Hypercholesterolemia Hyperlipidemias Lipid Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

MSD Korea Ltd.

Seoul, 121-705, South Korea

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Test meal

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.

Primary outcomes

  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 outcomes

  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).

Sponsors and collaborators

Lead sponsor

Organon and Co

Industry

Registry information

Official study title

A Multicenter, Cross-sectional Study to Evaluate Plasma ApoB-48 Concentration Among Korean Diabetic Patients (With Normal to Moderately High LDL-C Levels)

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Apr 12, 2011
Registry last updated
May 13, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.