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)

NCT01333436 | Completed Results

• 1 other identifier: 0653A-259
• Study Type: interventional
• Target: 93
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Dyslipidemia; Hypercholesterolemia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Postprandial Mean ApoB-48 Peak Levels

  up to 6 hours after Test Meal

• Fasting ApoB-48 Levels

  Baseline (Hour 0)

Study Arms (2)

Diabetic participants

EXPERIMENTAL

Diabetic participants with normal to moderately high LDL-C

Other: Test Meal

Nondiabetic participants

EXPERIMENTAL

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

Other: Test Meal

Interventions

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.

Diabetic participants; Nondiabetic participants

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participant has an LDL-C ranging from ≥100 mg/dL to \<160 mg/dL.
• Patient has a triglyceride (TG) level of ≤500 mg/dL.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Organon and Co: lead

Study Sites (1)

MSD Korea Ltd.

Seoul, 121-705, South Korea

Location

Related 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.2016.02.008. Epub 2016 Feb 23.

  PMID: 27173463 RESULT

MeSH Terms

Conditions

Dyslipidemias; Hypercholesterolemia

Condition Hierarchy (Ancestors)

Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Hyperlipidemias

Results Point of Contact

• Title: Senior Vice President, Global Clinical Development
• Organization: Merck Sharp & Dohme Corp.

ClinicalTrialsDisclosure@merck.com

1-800-672-6372

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 24, 2011
• First Posted: April 12, 2011
• Study Start: July 20, 2011
• Primary Completion: May 12, 2012
• Study Completion: May 12, 2012
• Last Updated: May 13, 2024
• Results First Posted: April 9, 2013

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)