Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Göteborg University | OTHER |
Not provided
Not provided
Not provided
Postprandial lipemia is highly prevalent in type 2 diabetes subjects even with normal fasting triglyceride values. Humans are mostly in a postprandial rather than in a fasting state and therefore non-fasting triglyceride values reflect more accurately the continuous exposure of arterial wall to the substantial cholesterol load from remnant particles. Evolocumab lowers blood LDL-cholesterol. This study evaluates the effect of evolocumab on postprandial lipid metabolism in type 2 diabetes. All participants in this study receive evolocumab treatment.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Evolocumab | Experimental | Evolocumab 140 mg subcutaneous injection once every 2 weeks for 12 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Evolocumab | Drug |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Mean ApoB Concentration Before and After Evolocumab | Change in apolipoprotein B concentration in total plasma measured by using turbidimetric immunoassay. | Baseline and after 12 weeks |
| Mean TRL-C Concentration Before and After Evolocumab | Change in TRL-cholesterol concentration in plasma samples measured by using automated direct assay (Denka Seiken, Tokyo, Japan) | Baseline and after 12 weeks |
| Mean Total Production of ApoB48 Before and After Evolocumab | Change in ApoB48 total production in plasma measured by using multicompartmental modeling. The power of mathematical modelling to describe the metabolic pathways of lipid and lipoprotein metabolism was demonstrated by Zech L et al (J Clin Invest 1979;63:1262-1273) and have been widely used over 30yrs. So far few studies have focused on the modelling of apo B48 and apo B100 after a meal that is more physiological than the fasting state (Björnson E et al. JIM 2019;285:562-577). Production rates for apo B48, apo B100 and triglycerides in chylomicrons, VLDL1 and VLDL2 were derived from samples taken before and after the tracer injection and after the meal at 0, 30, 45, 60, 75, 90, 120, 150 min and at 3, 4, 5, 6, 8, 10, 24 hrs and averages for 24 hrs. Analysis of tracer/ tracee curves of stable isotopes was used to derived the estimates of kinetic parameters using a new mathematical modeling per day. These figures per day are used to report the data from this study. | Baseline and after 12 weeks |
| Mean LDL FCR of ApoB100 Before and After Evolocumab | Change in low-density lipoprotein fractional catabolic rate of ApoB100 in LDL from plasma samples measured by multicompartmental modeling. Production rates were derived from samples taken before and after the tracer injection and after the meal at 0, 30, 45, 60, 75, 90, 120, 150 min and at 3, 4, 5, 6, 8, 10, 24 hrs and averages for 24 hrs. More detailed description see Outcome measure 3. | Baseline and after 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Mean LDL-C Concentration Before and After Evolocumab | Change in LDL-cholesterol concentration in plasma LDL fraction isolated by ultracentrifugation. | Baseline and after 12 weeks |
| Mean ApoB48 Concentration Before and After Evolocumab |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Marja-Riitta Taskinen, Prof., PI | Clinical Research institute Huch, Ltd and University of Helsinki | Principal Investigator |
| Jan Boren, Prof., co-PI | University of Gothenburg and Sahlgrenska University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Helsinki University Hospital, Biomedicum 2U | Helsinki | Finland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33356392 | Result | Taskinen MR, Bjornson E, Kahri J, Soderlund S, Matikainen N, Porthan K, Ainola M, Hakkarainen A, Lundbom N, Fermanelli V, Fuchs J, Thorsell A, Kronenberg F, Andersson L, Adiels M, Packard CJ, Boren J. Effects of Evolocumab on the Postprandial Kinetics of Apo (Apolipoprotein) B100- and B48-Containing Lipoproteins in Subjects With Type 2 Diabetes. Arterioscler Thromb Vasc Biol. 2021 Feb;41(2):962-975. doi: 10.1161/ATVBAHA.120.315446. Epub 2020 Dec 24. | |
| 31917184 |
Not provided
Not provided
Not provided
After an initial telephone interview of 195 subjects, 77 were invited for a screening visit. Of these, 63 subjects were excluded because of failure to meet inclusion criteria.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Evolocumab | Evolocumab 140 mg subcutaneous injection once every 2 weeks for 12 weeks |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Type II diabetic patients (a diagnosis of T2DM average duration 4.8 years). After an initial telephone interview of 195 subjects, 77 were invited for a screening visit. Of these, 63 subjects were excluded because of failure to meet inclusion criteria. All study subjects used daily stable doses of metformin and statin throughout the study period
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Evolocumab | Evolocumab 140 mg subcutaneous injection once every 2 weeks for 12 weeks |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of 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 | Mean ApoB Concentration Before and After Evolocumab | Change in apolipoprotein B concentration in total plasma measured by using turbidimetric immunoassay. | Posted | Mean | Standard Deviation | mg/dL | Baseline and after 12 weeks |
|
|
During 3 months of Evolocumab therapy
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 | Evolocumab | Evolocumab 140 mg subcutaneous injection once every 2 weeks for 12 weeks Evolocumab: Evolocumab 140 mg subcutaneous injection once every 2 weeks for 12 weeks |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Blood glucose elevation | Blood and lymphatic system disorders | Non-systematic Assessment | No causality to Amgen drug used in this study |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Postural vertigo | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Prof. Marja-Riitta Taskinen | Helsinki University and Helsinki University Hospital | +358-9-47171990 | marja-riitta.taskinen@helsinki.fi |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 27, 2016 | Jul 7, 2021 | Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D002318 | Cardiovascular Diseases |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C577155 | evolocumab |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| LDL Pool Size of ApoB100 Before and After Evolocumab | Change in low-density lipoprotein pool size of ApoB100 in LDL fraction prepared from plasma samples using density ultracentrifugation. | Baseline and after 12 weeks |
Change in apolipoprotein B48 levels in total plasma measured by enzyme-linked immunosorbent assay.
| Baseline and after 12 weeks |
| Mean CM TG-iAUC Before and After Evolocumab | Change in chylomicron triglyceride incremental area under curve in plasma samples taken at particular time points after the meal. Area under the curve (AUC) was normalized so that 100% corresponds to the AUC before treatment; subsequently the percentage after treatment is in reference to this value. AUC values were calculated using the trapezoidal rule. | 0, 2, 4, 6, 8 hours after the meal at baseline and after 12 weeks |
| Mean ApoB48 AUC Before and After Evolocumab | Change in apolipoprotein B48 area under curve in plasma samples taken at particular time points after the meal. Area under the curve (AUC) was normalized so that 100% corresponds to the AUC before treatment; subsequently the percentage after treatment is in reference to this value. AUC values were calculated using the trapezoidal rule. | 0, 2, 4, 6, 8 hours after the meal at baseline and after 12 weeks |
| Mean VLDL1 ApoB100 Production Before and After Evolocumab | Change in VLDL1 ApoB100 production rates measured from isolated VLDL from plasma samples using density ultracentrifugation and the enrichment of tracer was measured in isolated fractions following using mathematical modeling. Production rates were derived from samples taken before and after the tracer injection and after the meal at 0, 30, 45, 60, 75, 90, 120, 150 min and at 3, 4, 5, 6, 8, 10, 24 hrs and averages for 24 hrs. More detailed description see Outcome measure 3. | Baseline and after 12 weeks |
| Mean VLDL2 ApoB100 Production Before and After Evolocumab | Change in VLDL2 apoB100 production rates measured from isolated VLDL2 from plasma samples by using density ultracentrifugation and the enrichment of tracer was measured in isolated fractions following using mathematical modeling. Production rates were derived from samples taken before and after the tracer injection and after the meal at 0, 30, 45, 60, 75, 90, 120, 150 min and at 3, 4, 5, 6, 8, 10, 24 hrs and averages for 24 hrs. More detailed description see Outcome measure 3. | Baseline and after 12 weeks |
| IDL Pool Size of ApoB100 Before and After Evolocumab | Change in intermediate-density lipoprotein pool size of ApoB100 in IDL fraction prepared from plasma samples using density ultracentrifugation. | Baseline and after 12 weeks |
| Mean IDL to LDL Transfer of ApoB100 Before and After Evolocumab | Change in ApoB100 intermediate-density lipoprotein to low-density lipoprotein transfer in isolated samples from plasma by ultracentrifugation and measured using multicompartmental modeling. Production rates were derived from samples taken before and after the tracer injection and after the meal at 0, 30, 45, 60, 75, 90, 120, 150 min and at 3, 4, 5, 6, 8, 10, 24 hrs and averages for 24 hrs. More detailed description see Outcome measure 3. | Baseline and after 12 weeks |
| Mean VAT Before and After Evolocumab | Change in visceral fat volume measured by magnetic resonance imaging | Baseline and after 12 weeks |
| Mean Liver Fat Before and After Evolocumab | Change in liver fat content measured by magnetic resonance imaging. | Baseline and after 12 weeks |
| Mean SAT Before and After Evolocumab | Change in subcutaneous fat volume measured by magnetic resonance imaging | Baseline and after 12 weeks |
| Mean VLDL1 Triglyceride Production Before and After Evolocumab | Change in VLDL1 triglyceride production measured from isolated VLDL1 from plasma samples by using density gradient ultracentrifugation. Production rates were derived from samples taken before and after the tracer injection and after the meal at 0, 30, 45, 60, 75, 90, 120, 150 min and at 3, 4, 5, 6, 8, 10, 24 hrs and averages for 24 hrs. More detailed description see Outcome measure 3. | Baseline and after 12 weeks |
| Mean VLDL1 FCR of triglycerideBefore and After Evolocumab | Change in VLDL1 fractional catabolic rate of triglyceride measured in isolated VLDL1 from plasma samples by using density ultracentrifugation and measured by multicompartmental modeling. Production rates were derived from samples taken before and after the tracer injection and after the meal at 0, 30, 45, 60, 75, 90, 120, 150 min and at 3, 4, 5, 6, 8, 10, 24 hrs and averages for 24 hrs. More detailed description see Outcome measure 3. | Baseline and after 12 weeks |
| Mean VLDL2 Triglyceride Total Production Before and After Evolocumab | Change in VLDL2 triglyceride total production measured in isolated VLDL2 from plasma samples by using density ultracentrifugation and measured by multicompartmental modeling. Production rates were derived from samples taken before and after the tracer injection and after the meal at 0, 30, 45, 60, 75, 90, 120, 150 min and at 3, 4, 5, 6, 8, 10, 24 hrs and averages for 24 hrs. More detailed description see Outcome measure 3. | Baseline and after 12 weeks |
| Mean VLDL2 FCR of Triglyceride Before and After Evolocumab | Change in VLDL2 fractional catabolic rate of triglyceride measured in isolated VLDL2 from plasma samples by using density ultracentrifugation and measured by multicompartmental modeling. Production rates were derived from samples taken before and after the tracer injection and after the meal at 0, 30, 45, 60, 75, 90, 120, 150 min and at 3, 4, 5, 6, 8, 10, 24 hrs and averages for 24 hrs. More detailed description see Outcome measure 3. | Baseline and after 12 weeks |
| Mean Postprandial CM of ApoB48 Before and After Evolocumab | Change in Postprandial chylomicron of ApoB48 measured from plasma samples by liquid chromatography-mass spectrometry with multicompartmental modeling assay. Production rates were derived from samples taken before and after the tracer injection and after the meal at 0, 30, 45, 60, 75, 90, 120, 150 min and at 3, 4, 5, 6, 8, 10, 24 hrs and averages for 24 hrs. More detailed description see Outcome measure 3. | Baseline and after 12 weeks |
| Mean CM-apoB48 FCR of ApoB48 Metabolism Before and After Evolocumab | Change in chylomicron-apoB48 fractional catabolic rate of ApoB48 in isolated chylomicrons from plasma samples measured by multicompartmental modeling assay. Production rates were derived from samples taken before and after the tracer injection and after the meal at 0, 30, 45, 60, 75, 90, 120, 150 min and at 3, 4, 5, 6, 8, 10, 24 hrs and averages for 24 hrs. More detailed description see Outcome measure 3. | Baseline and after 12 weeks |
| Mean CM-TG Production of ApoB48 Before and After Evolocumab | Change in chylomicron-triglycerides production of ApoB48 in isolated chylomicrons from plasma samples measured by multicompartmental modeling assay. Production rates were derived from samples taken before and after the tracer injection and after the meal at 0, 30, 45, 60, 75, 90, 120, 150 min and at 3, 4, 5, 6, 8, 10, 24 hrs and averages for 24 hrs. More detailed description see Outcome measure 3. | Baseline and after 12 weeks |
| Mean CM TG-AUC Before and After Evolocumab | Change in chylomicron triglyceride area under curve in plasma at a particular time points after the meal. Area under the curve (AUC) was normalized so that 100% corresponds to the AUC before treatment; subsequently the percentage after treatment is in reference to this value. AUC values were calculated using the trapezoidal rule. | 0, 2, 4, 6, 8 hours after the meal at baseline and after 12 weeks |
| Mean ApoB48 iAUC Before and After Evolocumab | Change in apolipoprotein B48 incremental area under curve in plasma at a particular time points after the meal. Area under the curve (AUC) was normalized so that 100% corresponds to the AUC before treatment; subsequently the percentage after treatment is in reference to this value. AUC values were calculated using the trapezoidal rule. | 0, 2, 4, 6, 8 hours after the meal at baseline and after 12 weeks |
| Result |
| Taskinen MR, Bjornson E, Andersson L, Kahri J, Porthan K, Matikainen N, Soderlund S, Pietilainen K, Hakkarainen A, Lundbom N, Nilsson R, Stahlman M, Adiels M, Parini P, Packard C, Boren J. Impact of proprotein convertase subtilisin/kexin type 9 inhibition with evolocumab on the postprandial responses of triglyceride-rich lipoproteins in type II diabetic subjects. J Clin Lipidol. 2020 Jan-Feb;14(1):77-87. doi: 10.1016/j.jacl.2019.12.003. Epub 2019 Dec 12. |
| 221537 | Result | Zech LA, Grundy SM, Steinberg D, Berman M. Kinetic model for production and metabolism of very low density lipoprotein triglycerides. Evidence for a slow production pathway and results for normolipidemic subjects. J Clin Invest. 1979 Jun;63(6):1262-73. doi: 10.1172/JCI109421. |
| 30779243 | Result | Bjornson E, Packard CJ, Adiels M, Andersson L, Matikainen N, Soderlund S, Kahri J, Sihlbom C, Thorsell A, Zhou H, Taskinen MR, Boren J. Investigation of human apoB48 metabolism using a new, integrated non-steady-state model of apoB48 and apoB100 kinetics. J Intern Med. 2019 May;285(5):562-577. doi: 10.1111/joim.12877. Epub 2019 Mar 12. |
| 37775612 | Derived | Taskinen MR, Matikainen N, Bjornson E, Soderlund S, Inkeri J, Hakkarainen A, Parviainen H, Sihlbom C, Thorsell A, Andersson L, Adiels M, Packard CJ, Boren J. Contribution of intestinal triglyceride-rich lipoproteins to residual atherosclerotic cardiovascular disease risk in individuals with type 2 diabetes on statin therapy. Diabetologia. 2023 Dec;66(12):2307-2319. doi: 10.1007/s00125-023-06008-0. Epub 2023 Sep 29. |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
|
|
| Primary | Mean TRL-C Concentration Before and After Evolocumab | Change in TRL-cholesterol concentration in plasma samples measured by using automated direct assay (Denka Seiken, Tokyo, Japan) | Posted | Mean | Standard Deviation | mg/dL | Baseline and after 12 weeks |
|
|
|
|
| Primary | Mean Total Production of ApoB48 Before and After Evolocumab | Change in ApoB48 total production in plasma measured by using multicompartmental modeling. The power of mathematical modelling to describe the metabolic pathways of lipid and lipoprotein metabolism was demonstrated by Zech L et al (J Clin Invest 1979;63:1262-1273) and have been widely used over 30yrs. So far few studies have focused on the modelling of apo B48 and apo B100 after a meal that is more physiological than the fasting state (Björnson E et al. JIM 2019;285:562-577). Production rates for apo B48, apo B100 and triglycerides in chylomicrons, VLDL1 and VLDL2 were derived from samples taken before and after the tracer injection and after the meal at 0, 30, 45, 60, 75, 90, 120, 150 min and at 3, 4, 5, 6, 8, 10, 24 hrs and averages for 24 hrs. Analysis of tracer/ tracee curves of stable isotopes was used to derived the estimates of kinetic parameters using a new mathematical modeling per day. These figures per day are used to report the data from this study. | Posted | Mean | Standard Deviation | mg/d | Baseline and after 12 weeks |
|
|
|
|
| Primary | Mean LDL FCR of ApoB100 Before and After Evolocumab | Change in low-density lipoprotein fractional catabolic rate of ApoB100 in LDL from plasma samples measured by multicompartmental modeling. Production rates were derived from samples taken before and after the tracer injection and after the meal at 0, 30, 45, 60, 75, 90, 120, 150 min and at 3, 4, 5, 6, 8, 10, 24 hrs and averages for 24 hrs. More detailed description see Outcome measure 3. | Posted | Mean | Standard Deviation | pools/d | Baseline and after 12 weeks |
|
|
|
|
| Primary | LDL Pool Size of ApoB100 Before and After Evolocumab | Change in low-density lipoprotein pool size of ApoB100 in LDL fraction prepared from plasma samples using density ultracentrifugation. | Posted | Mean | Standard Deviation | mg | Baseline and after 12 weeks |
|
|
|
|
| Secondary | Mean LDL-C Concentration Before and After Evolocumab | Change in LDL-cholesterol concentration in plasma LDL fraction isolated by ultracentrifugation. | Posted | Mean | Standard Deviation | mg | Baseline and after 12 weeks |
|
|
|
|
| Secondary | Mean ApoB48 Concentration Before and After Evolocumab | Change in apolipoprotein B48 levels in total plasma measured by enzyme-linked immunosorbent assay. | Posted | Mean | Standard Deviation | mg/L | Baseline and after 12 weeks |
|
|
|
|
| Secondary | Mean CM TG-iAUC Before and After Evolocumab | Change in chylomicron triglyceride incremental area under curve in plasma samples taken at particular time points after the meal. Area under the curve (AUC) was normalized so that 100% corresponds to the AUC before treatment; subsequently the percentage after treatment is in reference to this value. AUC values were calculated using the trapezoidal rule. | Posted | Mean | Standard Deviation | (mmol/l)*h | 0, 2, 4, 6, 8 hours after the meal at baseline and after 12 weeks |
|
|
|
|
| Secondary | Mean ApoB48 AUC Before and After Evolocumab | Change in apolipoprotein B48 area under curve in plasma samples taken at particular time points after the meal. Area under the curve (AUC) was normalized so that 100% corresponds to the AUC before treatment; subsequently the percentage after treatment is in reference to this value. AUC values were calculated using the trapezoidal rule. | Posted | Mean | Standard Deviation | (mg/l)*h | 0, 2, 4, 6, 8 hours after the meal at baseline and after 12 weeks |
|
|
|
|
| Secondary | Mean VLDL1 ApoB100 Production Before and After Evolocumab | Change in VLDL1 ApoB100 production rates measured from isolated VLDL from plasma samples using density ultracentrifugation and the enrichment of tracer was measured in isolated fractions following using mathematical modeling. Production rates were derived from samples taken before and after the tracer injection and after the meal at 0, 30, 45, 60, 75, 90, 120, 150 min and at 3, 4, 5, 6, 8, 10, 24 hrs and averages for 24 hrs. More detailed description see Outcome measure 3. | Posted | Mean | Standard Deviation | mg/d | Baseline and after 12 weeks |
|
|
|
|
| Secondary | Mean VLDL2 ApoB100 Production Before and After Evolocumab | Change in VLDL2 apoB100 production rates measured from isolated VLDL2 from plasma samples by using density ultracentrifugation and the enrichment of tracer was measured in isolated fractions following using mathematical modeling. Production rates were derived from samples taken before and after the tracer injection and after the meal at 0, 30, 45, 60, 75, 90, 120, 150 min and at 3, 4, 5, 6, 8, 10, 24 hrs and averages for 24 hrs. More detailed description see Outcome measure 3. | Posted | Mean | Standard Deviation | mg/d | Baseline and after 12 weeks |
|
|
|
|
| Secondary | IDL Pool Size of ApoB100 Before and After Evolocumab | Change in intermediate-density lipoprotein pool size of ApoB100 in IDL fraction prepared from plasma samples using density ultracentrifugation. | Posted | Mean | Standard Deviation | mg | Baseline and after 12 weeks |
|
|
|
|
| Secondary | Mean IDL to LDL Transfer of ApoB100 Before and After Evolocumab | Change in ApoB100 intermediate-density lipoprotein to low-density lipoprotein transfer in isolated samples from plasma by ultracentrifugation and measured using multicompartmental modeling. Production rates were derived from samples taken before and after the tracer injection and after the meal at 0, 30, 45, 60, 75, 90, 120, 150 min and at 3, 4, 5, 6, 8, 10, 24 hrs and averages for 24 hrs. More detailed description see Outcome measure 3. | Posted | Mean | Standard Deviation | mg/d | Baseline and after 12 weeks |
|
|
|
|
| Secondary | Mean VAT Before and After Evolocumab | Change in visceral fat volume measured by magnetic resonance imaging | Posted | Mean | Standard Deviation | cm3 | Baseline and after 12 weeks |
|
|
|
|
| Secondary | Mean Liver Fat Before and After Evolocumab | Change in liver fat content measured by magnetic resonance imaging. | Posted | Mean | Standard Deviation | fat % | Baseline and after 12 weeks |
|
|
|
|
| Secondary | Mean SAT Before and After Evolocumab | Change in subcutaneous fat volume measured by magnetic resonance imaging | Posted | Mean | Standard Deviation | cm3 | Baseline and after 12 weeks |
|
|
|
|
| Secondary | Mean VLDL1 Triglyceride Production Before and After Evolocumab | Change in VLDL1 triglyceride production measured from isolated VLDL1 from plasma samples by using density gradient ultracentrifugation. Production rates were derived from samples taken before and after the tracer injection and after the meal at 0, 30, 45, 60, 75, 90, 120, 150 min and at 3, 4, 5, 6, 8, 10, 24 hrs and averages for 24 hrs. More detailed description see Outcome measure 3. | Posted | Mean | Standard Deviation | g/d | Baseline and after 12 weeks |
|
|
|
|
| Secondary | Mean VLDL1 FCR of triglycerideBefore and After Evolocumab | Change in VLDL1 fractional catabolic rate of triglyceride measured in isolated VLDL1 from plasma samples by using density ultracentrifugation and measured by multicompartmental modeling. Production rates were derived from samples taken before and after the tracer injection and after the meal at 0, 30, 45, 60, 75, 90, 120, 150 min and at 3, 4, 5, 6, 8, 10, 24 hrs and averages for 24 hrs. More detailed description see Outcome measure 3. | Posted | Mean | Standard Deviation | pools/d | Baseline and after 12 weeks |
|
|
|
|
| Secondary | Mean VLDL2 Triglyceride Total Production Before and After Evolocumab | Change in VLDL2 triglyceride total production measured in isolated VLDL2 from plasma samples by using density ultracentrifugation and measured by multicompartmental modeling. Production rates were derived from samples taken before and after the tracer injection and after the meal at 0, 30, 45, 60, 75, 90, 120, 150 min and at 3, 4, 5, 6, 8, 10, 24 hrs and averages for 24 hrs. More detailed description see Outcome measure 3. | Posted | Mean | Standard Deviation | g/d | Baseline and after 12 weeks |
|
|
|
|
| Secondary | Mean VLDL2 FCR of Triglyceride Before and After Evolocumab | Change in VLDL2 fractional catabolic rate of triglyceride measured in isolated VLDL2 from plasma samples by using density ultracentrifugation and measured by multicompartmental modeling. Production rates were derived from samples taken before and after the tracer injection and after the meal at 0, 30, 45, 60, 75, 90, 120, 150 min and at 3, 4, 5, 6, 8, 10, 24 hrs and averages for 24 hrs. More detailed description see Outcome measure 3. | Posted | Mean | Standard Deviation | pools/d | Baseline and after 12 weeks |
|
|
|
|
| Secondary | Mean Postprandial CM of ApoB48 Before and After Evolocumab | Change in Postprandial chylomicron of ApoB48 measured from plasma samples by liquid chromatography-mass spectrometry with multicompartmental modeling assay. Production rates were derived from samples taken before and after the tracer injection and after the meal at 0, 30, 45, 60, 75, 90, 120, 150 min and at 3, 4, 5, 6, 8, 10, 24 hrs and averages for 24 hrs. More detailed description see Outcome measure 3. | Posted | Mean | Standard Deviation | mg/d | Baseline and after 12 weeks |
|
|
|
|
| Secondary | Mean CM-apoB48 FCR of ApoB48 Metabolism Before and After Evolocumab | Change in chylomicron-apoB48 fractional catabolic rate of ApoB48 in isolated chylomicrons from plasma samples measured by multicompartmental modeling assay. Production rates were derived from samples taken before and after the tracer injection and after the meal at 0, 30, 45, 60, 75, 90, 120, 150 min and at 3, 4, 5, 6, 8, 10, 24 hrs and averages for 24 hrs. More detailed description see Outcome measure 3. | Posted | Mean | Standard Deviation | pools/d | Baseline and after 12 weeks |
|
|
|
|
| Secondary | Mean CM-TG Production of ApoB48 Before and After Evolocumab | Change in chylomicron-triglycerides production of ApoB48 in isolated chylomicrons from plasma samples measured by multicompartmental modeling assay. Production rates were derived from samples taken before and after the tracer injection and after the meal at 0, 30, 45, 60, 75, 90, 120, 150 min and at 3, 4, 5, 6, 8, 10, 24 hrs and averages for 24 hrs. More detailed description see Outcome measure 3. | Posted | Mean | Standard Deviation | g/d | Baseline and after 12 weeks |
|
|
|
| Secondary | Mean CM TG-AUC Before and After Evolocumab | Change in chylomicron triglyceride area under curve in plasma at a particular time points after the meal. Area under the curve (AUC) was normalized so that 100% corresponds to the AUC before treatment; subsequently the percentage after treatment is in reference to this value. AUC values were calculated using the trapezoidal rule. | Posted | Mean | Standard Deviation | (mmol/l)*h | 0, 2, 4, 6, 8 hours after the meal at baseline and after 12 weeks |
|
|
|
|
| Secondary | Mean ApoB48 iAUC Before and After Evolocumab | Change in apolipoprotein B48 incremental area under curve in plasma at a particular time points after the meal. Area under the curve (AUC) was normalized so that 100% corresponds to the AUC before treatment; subsequently the percentage after treatment is in reference to this value. AUC values were calculated using the trapezoidal rule. | Posted | Mean | Standard Deviation | (mg/l)*h | 0, 2, 4, 6, 8 hours after the meal at baseline and after 12 weeks |
|
|
|
|
| 0 |
| 13 |
| 3 |
| 13 |
| 13 |
| 13 |
|
| Non-cardiac chest pain | General disorders | Non-systematic Assessment | No causality to Amgen drug used in this study |
|
| Iron deficiency anemia | Blood and lymphatic system disorders | Non-systematic Assessment | No causality to Amgen drug used in this study |
|
| Bradycardia | Cardiac disorders | Non-systematic Assessment |
|
| Respiratory infection | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Fungal nail disease | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Anemia | Blood and lymphatic system disorders | Non-systematic Assessment |
|
| Headache | Nervous system disorders | Non-systematic Assessment |
|
| Dizziness | Nervous system disorders | Non-systematic Assessment |
|
| Skin eruption | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Hypertension | Blood and lymphatic system disorders | Non-systematic Assessment |
|
| Bronchitis | Infections and infestations | Non-systematic Assessment |
|
| Herpes simplex labialis | Infections and infestations | Non-systematic Assessment |
|
| Tinnitus | Nervous system disorders | Non-systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Tachycardia | Cardiac disorders | Non-systematic Assessment |
|
| Pyuria | Renal and urinary disorders | Non-systematic Assessment |
|
| Edema | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Eosinophilia | Blood and lymphatic system disorders | Non-systematic Assessment |
|
| Thrombocytosis | Blood and lymphatic system disorders | Non-systematic Assessment |
|
| Urinary tract infection | Renal and urinary disorders | Non-systematic Assessment |
|
| Gastroenteritis | Gastrointestinal disorders | Non-systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | Non-systematic Assessment |
|
| Macrocytosis | Blood and lymphatic system disorders | Non-systematic Assessment |
|
| Hematuria | Blood and lymphatic system disorders | Non-systematic Assessment |
|
| Microcytosis | Blood and lymphatic system disorders | Non-systematic Assessment |
|
Not provided
Not provided
| D004700 | Endocrine System Diseases |