Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Diabetic participants | Experimental | Diabetic participants with normal to moderately high LDL-C |
|
| Nondiabetic participants | Experimental | Non-diabetic participants with normal to moderately high LDL-C |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Fasting ApoB-48 Levels |
Not provided
Inclusion criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| MSD Korea Ltd. | Seoul | 121-705 | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27173463 | Result | 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. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Diabetic Participants | Diabetic participants with normal to moderately high low-density lipoprotein-cholesterol (LDL-C) administered a test meal by the Sponsor during Visit 2 consisting of approximately 944 kcal (57% fat, 31% carbohydrate, and 12% protein). |
| FG001 | Nondiabetic Participants |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
ApoB-48 levels measured after at least a 12-hour fast and prior to administration of test meal (Hour 0).
| Baseline (Hour 0) |
Non-diabetic participants with normal to moderately high LDL-C administered a test meal by the Sponsor during Visit 2 consisting of approximately 944 kcal (57% fat, 31% carbohydrate, and 12% protein). |
| COMPLETED |
|
| NOT COMPLETED |
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Diabetic Participants | Diabetic participants with normal to moderately high low-density lipoprotein-cholesterol (LDL-C) administered a test meal by the Sponsor during Visit 2 consisting of approximately 944 kcal (57% fat, 31% carbohydrate, and 12% protein. |
| BG001 | Nondiabetic Participants | Non-diabetic participants with normal to moderately high LDL-C administered a test meal by the Sponsor during Visit 2 consisting of approximately 944 kcal ( 57% fat, 31% carbohydrate, and 12% protein). |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Full-Analysis-Set (FAS) population defined as all participants who had valid postprandial ApoB-48 measurements for all specified time points to calculate iAUC. | Posted | Mean | Standard Deviation | μg/mL x h | 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. | Full-Analysis-Set (FAS) population defined as all participants who had valid postprandial ApoB-48 measurements for all specified time points to calculate iAUC. | Posted | Mean | Standard Deviation | μg/mL | 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). | Full-Analysis-Set (FAS) population defined as all participants who had valid postprandial ApoB-48 measurements for all specified time points to calculate iAUC. | Posted | Mean | Standard Deviation | μg/mL | Baseline (Hour 0) |
|
|
Not provided
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Diabetic Participants | Diabetic participants with normal to moderately high low-density lipoprotein-cholesterol (LDL-C) administered a test meal by the Sponsor during Visit 2 consisting of approximately 944 kcal (57% fat, 31% carbohydrate, and 12% protein). | 0 | 43 | 0 | 43 | ||
| EG001 | Nondiabetic Participants | Non-diabetic participants with normal to moderately high LDL-C administered a test meal by the Sponsor during Visit 2 consisting of approximately 944 kcal (57% fat, 31% carbohydrate, and 12% protein). | 0 | 50 | 0 | 50 |
Not provided
Not provided
Subsequent to the multicenter publication, or 24 months after completion of the study, whichever comes first, an investigator and/or his/her colleagues may publish the results for their study site independently. The SPONSOR must have the opportunity to review all proposed abstracts, manuscripts, or presentations regarding this study 60 days prior to submission for publication/presentation.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Vice President, Global Clinical Development | Merck Sharp & Dohme Corp. | 1-800-672-6372 | ClinicalTrialsDisclosure@merck.com |
| ID | Term |
|---|---|
| D050171 | Dyslipidemias |
| D006937 | Hypercholesterolemia |
| ID | Term |
|---|---|
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D006949 | Hyperlipidemias |
Not provided
Not provided
| Male |
|
|
|
|
|