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| ID | Type | Description | Link |
|---|---|---|---|
| 2012-003577-26 | EudraCT Number |
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| Name | Class |
|---|---|
| Novo Nordisk A/S | INDUSTRY |
| University of Copenhagen | OTHER |
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Recent studies in rodents show that glucagon-like peptide-1 (GLP-1) analogues protect against diabetic nephropathy. We hypothesise that this is also the case in humans. This study will investigate the short-term effect of liraglutide (GLP-1 analogue) on the kidneys in type 2 diabetic patients. Impact on basic kidney physiological will be determined and kidney injury markers will be measured as surrogate parameters of kidney protection.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Liraglutide | Experimental | 1.2 mg liraglutide sc. (single-dose) |
|
| Placebo-liraglutide | Placebo Comparator | Placebo liraglutide sc. (single-dose) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Liraglutide | Drug |
|
| |
| Placebo-liraglutide |
| Measure | Description | Time Frame |
|---|---|---|
| Glomerular Filtration Rate (51Cr-EDTA plasma clearance) | 10-15 hours post-dose |
| Measure | Description | Time Frame |
|---|---|---|
| Renal Blood Flow (functional magnetic resonance imaging) | 15 hours post-dose | |
| Renal electrolyte clearance | Sodium, potassium, calcium, lithium and osmotically active substances. | 10-15 hours post-dose |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jens S Christiansen, Professor | Aarhus University Hospital, Department of Endocrinology and Diabetes | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Aarhus University Hospital, Department of Endocrinology and Diabetes | Aarhus | 8000 | Denmark |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D003920 | Diabetes Mellitus |
| D003928 | Diabetic Nephropathies |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| D000069450 | Liraglutide |
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D052216 | Glucagon-Like Peptide 1 |
| D004763 | Glucagon-Like Peptides |
| D052336 | Proglucagon |
| D005768 | Gastrointestinal Hormones |
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| Drug |
|
|
| Excretion of kidney injury markers | Albumin, NGAL, KIM-1, angiotensinogen and 8-OHdG. | 0-10 hours and 10-15 hours post-dose |
| Plasma concentrations of various hormones | Angiotensin II, renin, aldosterone, atrial natriuretic peptide, catecholamines. | 10-15 hours post-dose |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D048909 | Diabetes Complications |
| D006728 |
| Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |