Chronic Kidney Diseases Clinical Trial
— MCR_EndCirOfficial title:
The Role of the Kidneys and Liver in the Elimination of Glucagon An Evaluation of the Metabolic Clearance Rate of Glucagon in Patients With End-stage Renal Disease and Patients With Liver Cirrhosis
Verified date | May 2023 |
Source | University Hospital, Gentofte, Copenhagen |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The study aims to evaluate the kinetics and effect of glucagon in patients with chronic kidney disease and liver cirrhosis and matched healthy subjects, respectively.
Status | Completed |
Enrollment | 48 |
Est. completion date | March 28, 2023 |
Est. primary completion date | March 28, 2023 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 75 Years |
Eligibility | Inclusion Criteria: The CKD group - Men/women between 18 and 75 years of age - CKD stage 4 or 5 - Normal liver function (alanine aminotransferase (ALAT), aspartate aminotransferase (ASAT), albumin and coagulation factor II, VII and X (INR) within normal range, - Informed consent The cirrhosis group - Men/women between 18 and 75 years of age - Verified diagnosis of cirrhosis - Child-Pugh Score of 5-12 - Normal kidney function (estimated glomerular filtration rate (eGFR) above 60 ml/min/1.73m2 and absence of proteinuria) - Informed consent The control group - Men/women between 18 and 75 years of age - Normal kidney function (estimated glomerular filtration rate (eGFR) above 60 ml/min/1.73m2 and absence of proteinuria)(plasma creatinine =105 micromol/L (µM) for men and =90 µM for women) - Normal liver function (alanine aminotransferase (ALAT), aspartate aminotransferase (ASAT), albumin and coagulation factor II, VII and X (INR) within normal range - Informed consent Exclusion Criteria: All groups - Diagnosis of diabetes and/or HbA1c =43 mmol/mol and/or fasting plasma glucose =6 mmol/l. - Previous kidney transplantation with remaining kidney graft - Present treatment with oral glucocorticoids - Polycystic kidney disease - Pregnancy or breastfeeding - Inflammatory bowel disease - Surgical procedure within the last 3 months - Haemoglobin < 6 mmol/l (women) or < 7 mmol/l (men) - First-degree relatives with diabetes - Any condition that the investigators feel would interfere with trial participation |
Country | Name | City | State |
---|---|---|---|
Denmark | Center for Clinical Metabolic Research, Department of Medicine, Gentofte Hospital | Hellerup | Copenhagen |
Lead Sponsor | Collaborator |
---|---|
University Hospital, Gentofte, Copenhagen | The Novo Nordisk Foundation Center for Basic Metabolic Research |
Denmark,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Metabolic clearance rate of glucagon | Glucagon plasma concentration steady state glucagon concentrations | t = 50 minutes | |
Secondary | Glucagon pharmacokinetic 1 | Elimination half-life | -120, -90, -60, -30, -15, 0, 5, 10, 20, 50, 55, 60, 62, 64, 66, 68, 70, 75, 80, 85, 90, 120 minutes | |
Secondary | Glucagon pharmacokinetic 2 | volume of distribution of Glucagon | -120, -90, -60, -30, -15, 0, 5, 10, 20, 50, 55, 60, 62, 64, 66, 68, 70, 75, 80, 85, 90, 120 minutes | |
Secondary | Glucagon pharmacodynamic - amino acids | Effect of glucagon on amino acid plasma levels before, during and after infusion | -120, -90, -60, -30, -15, 0, 5, 10, 20, 50, 55, 60, 62, 64, 66, 68, 70, 75, 80, 85, 90, 120 minutes | |
Secondary | Glucagon pharmacodynamic - glucose | Effect of glucagon on plasma glucose levels before, during and after infusion | -120, -90, -60, -30, -15, 0, 5, 10, 20, 50, 55, 60, 62, 64, 66, 68, 70, 75, 80, 85, 90, 120 minutes | |
Secondary | Tracers | Tracer-to-tracee ratio of labelled isotopes | -120, -90, -60, -30, -15, 0, 5, 10, 20, 50, 55, 60, 62, 64, 66, 68, 70, 75, 80, 85, 90, 120 | |
Secondary | Insulin | Excursions of plasma concentrations of insulin | -120, -90, -60, -30, -15, 0, 5, 10, 20, 50, 55, 60, 62, 64, 66, 68, 70, 75, 80, 85, 90, 120 minutes | |
Secondary | Glucagon-like peptide 1 | Excursions of plasma concentrations of GLP-1 | -120, -90, -60, -30, -15, 0, 5, 10, 20, 50, 55, 60, 62, 64, 66, 68, 70, 75, 80, 85, 90, 120 minutes | |
Secondary | Lipid metabolism | Effect of glucagon on lipid metabolism, through lipidomics | -120, -90, -60, -30, -15, 0, 5, 10, 20, 50, 55, 60, 62, 64, 66, 68, 70, 75, 80, 85, 90, 120 minutes | |
Secondary | Vital parameter 1 | Systolic blood pressure | -120, -30, 0, 60, 120 minutes | |
Secondary | Vital parameter 2 | Diastolic blood pressure | -120, -30, 0, 60, 120 minutes | |
Secondary | Vital parameter 3 | Heart rate | -120, -30, 0, 60, 120 minutes |
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