Clinical trial

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

Name
H-16043802
Description
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.
Trial arms
Trial start
2020-08-01
Estimated PCD
2023-03-28
Trial end
2023-03-28
Status
Completed
Treatment
Glucagon infusion
One hour glucagon-clamp followed by one hour of blood sampling
Arms:
Healthy control subjects, Patients with End-stage Renal Disease, Patients with liver cirrhosis
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,
Arms:
Healthy control subjects, Patients with End-stage Renal Disease, Patients with liver cirrhosis
Size
48
Primary endpoint
Metabolic clearance rate of glucagon
t = 50 minutes
Eligibility criteria
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
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'NON_RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'BASIC_SCIENCE', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 48, 'type': 'ACTUAL'}}
Updated at
2023-05-12

1 organization

2 products

3 indications

Product
Glucagon
Indication
Cirrhosis