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)

Organon

Status: Completed

Conditions: Hypercholesterolemia; Dyslipidemia

Treatments: Other: Test Meal

Study type: Interventional

Funder types: Industry

Identifiers

NCT01333436

0653A-259

Details and patient eligibility

About

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.

Enrollment: 93 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

93 participants in 2 patient groups

Diabetic participants

Experimental group

Description:

Diabetic participants with normal to moderately high LDL-C

Treatment:

Other: Test Meal

Nondiabetic participants

Experimental group

Description:

Non-diabetic participants with normal to moderately high LDL-C

Treatment:

Other: Test Meal