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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05056584
Other study ID # H-16043802
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date August 1, 2020
Est. completion date March 28, 2023

Study information

Verified date May 2023
Source University Hospital, Gentofte, Copenhagen
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Description:

In the present project the investigators wish to identify whether the effect, elimination and degradation of glucagon differ between healthy control subjects and patients with Chronic Kidney Disease (CKD) and liver cirrhosis, respectively. By performing glucagon infusions on healthy control subjects and matched subjects with either limited renal and hepatic function, the contribution of both organs to the metabolic clearance rate (MCR) of glucagon can be tested. A primed infusion of stable isotopic labelled tracers will allow the researchers to investigate the effects of the glucagon infusion on the glucose, lipid and amino acid metabolism. The quantification of the MCR of glucagon will be accompanied by a range of pharmacodynamic measures in order to substantiate whether a potentially altered glucagon MCR inflicts pharmacodynamic changes of glucagon, which could contribute to the pathophysiology of CKD and liver cirrhosis.


Recruitment information / eligibility

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

Study Design


Intervention

Biological:
Glucagon infusion
One hour glucagon-clamp followed by one hour of blood sampling
Primed tracer infusion
Infusion of primed isotopically labelled glucose, amino acids and lipids. From 2 hours prior to glucagon infusion and throughout the test day,

Locations

Country Name City State
Denmark Center for Clinical Metabolic Research, Department of Medicine, Gentofte Hospital Hellerup Copenhagen

Sponsors (2)

Lead Sponsor Collaborator
University Hospital, Gentofte, Copenhagen The Novo Nordisk Foundation Center for Basic Metabolic Research

Country where clinical trial is conducted

Denmark, 

Outcome

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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