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)

Completed NA Results posted Last updated 13 May 2024

What this trial tests

NA trial testing Test Meal in Dyslipidemia in 93 participants. Completed in 12 May 2012.

Timeline

20 July 2011

Primary endpoint
12 May 2012

12 May 2012

Quick facts

Lead sponsor	Organon and Co
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	none
Primary purpose	diagnostic
Enrollment	93
Start date	20 July 2011
Primary completion	12 May 2012
Estimated completion	12 May 2012
Sites	1 location across South Korea

Drugs / interventions tested

• Test Meal — full drug profile →

Conditions studied

• Dyslipidemia — all drugs for Dyslipidemia →
• Hypercholesterolemia — all drugs for Hypercholesterolemia →

Sponsor

Organon and Co — full company profile →

Who can join

18 and older, any sex, with Dyslipidemia or Hypercholesterolemia. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Postprandial Incremental Area Under the Curve From 0-6 Hours (iAUC)[0-6] of Apolipoprotein B-48 (ApoB-48) Primary · 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.

Group	Value	95% CI
Diabetic Participants	63.4	± 42.4
Nondiabetic Participants	41.7	± 30.9

Postprandial Mean ApoB-48 Peak Levels Secondary · 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.

Group	Value	95% CI
Diabetic Participants	24.8	± 15.7
Nondiabetic Participants	19.3	± 11.9

Fasting ApoB-48 Levels Secondary · Baseline (Hour 0)

ApoB-48 levels measured after at least a 12-hour fast and prior to administration of test meal (Hour 0).

Group	Value	95% CI
Diabetic Participants	5.9	± 3.5
Nondiabetic Participants	7.3	± 5.8

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.