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| ID | Type | Description | Link |
|---|---|---|---|
| 2021-005899-18 | EudraCT Number | ||
| U1111-1270-0957 | Other Identifier | World Health Organization (WHO) |
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In this study biomarkers in the blood after exposure to heparin in the fasted state or after a high-fat meal will be investigated. Heparin will be administered as an intravenous (iv) injection (injection directly in a blood vessel). In this study, the effects of administration of heparin will be compared with the effects of administration of normal saline which will also be administered as an iv injection.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 (low dose-high dose) | Experimental | Participants receive 25 IU/kg heparin on days 1 and 2, and 50 IU/kg Heparin on days 4 and 5 |
|
| Group 2 (high dose-low dose) | Experimental | Participants receive 50 IU/kg heparin on days 1 and 2, and 25 IU/kg Heparin on days 4 and 5 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Heparin | Drug | intravenous [iv] injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in Lipoprotein Lipase (LPL) levels before and after heparin exposure both in fasted and postprandial state | ng/ml | day -1 to day 6 |
| Change from baseline in LPL activity before and after heparin exposure both in fasted and postprandial state | µmol/l/min | day -1 to day 6 |
| Change from baseline in Triglycerides (TG) levels before and after heparin exposure both in fasted and postprandial state | mmol/L | day -1 to day 6 |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in apolipoprotein CII (APOCII) levels before and after heparin exposure both in fasted and postprandial state | mg/L | day -1 to day 6 |
| Change from baseline in APOCIII levels before and after heparin exposure both in fasted and postprandial state |
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Inclusion Criteria:
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Transparency (dept. 2834) | Novo Nordisk A/S | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novo Nordisk Investigational Site | Groningen | 9728 NZ | Netherlands |
According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
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mg/dl |
| day -1 to day 6 |
| Change from baseline in total cholesterol levels before and after heparin exposure both in fasted and postprandial state | mmol/L | day -1 to day 6 |
| Change from baseline in Free fatty acids (FFA) levels before and after heparin exposure both in fasted and postprandial state | mmol/L | day -1 to day 6 |
| Change from baseline in Lipoprotein profiling (very-low-density lipoprotein (VLDL), low-density lipoprotein (LDL), high-density lipoprotein (HDL) before and after heparin exposure both in fasted and postprandial state | mmol.L-1 | day -1 to day 6 |
| Change from baseline in adverse events (AEs) before and after heparin exposure both in fasted and postprandial state | Number of events | day -1 to day 6 |
| ID | Term |
|---|---|
| D006493 | Heparin |
| ID | Term |
|---|---|
| D006025 | Glycosaminoglycans |
| D011134 | Polysaccharides |
| D002241 | Carbohydrates |
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