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)

Hypercholesterolemia Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01333436
• Other study ID #: 0653A-259
• Status: Completed
• Phase: N/A
• Start date: July 20, 2011
• Est. completion date: May 12, 2012

Study information

• Verified date: February 2022
• Source: Organon and Co
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 93
• Est. completion date: May 12, 2012
• Est. primary completion date: May 12, 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Dyslipidemia
• Dyslipidemias
• Hypercholesterolemia

Intervention

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.

Locations

Country	Name	City	State
Korea, Republic of	MSD Korea Ltd.	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Organon and Co

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (1)

Park CY, Park JY, Choi J, Kim DJ, Park KS, Yoon KH, Lee MK, Park SW. Increased postprandial apolipoprotein B-48 level after a test meal in diabetic patients: A multicenter, cross-sectional study. Metabolism. 2016 Jun;65(6):843-51. doi: 10.1016/j.metabol.2 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postprandial Incremental Area Under the Curve From 0-6 Hours (iAUC)[0-6] of Apolipoprotein B-48 (ApoB-48)	ApoB-48 levels were measured at 1, 2, 3, 4, and 6 hours after the administration of the test meal.	up to 6 hours after Test Meal
Secondary	Postprandial Mean ApoB-48 Peak Levels	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.	up to 6 hours after Test Meal
Secondary	Fasting ApoB-48 Levels	ApoB-48 levels measured after at least a 12-hour fast and prior to administration of test meal (Hour 0).	Baseline (Hour 0)