Status:
COMPLETED
The Effect of Lifestyle-induced Hepatic Steatosis on Glucagon-stimulated Amino Acid Turnover
Lead Sponsor:
Malte Palm Suppli, MD
Collaborating Sponsors:
Section of Molecular Physiology, Department of Nutrition, Exercise and Sports, Faculty of Science, University of Copenhagen, Denmark
Clinical Metabolomics Core Facility, Department of Clinical, Biochemistry, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark
Conditions:
Non-Alcoholic Fatty Liver Disease
Glucagon Resistance
Eligibility:
MALE
20-65 years
Phase:
NA
Brief Summary
Many patients with type 2 diabetes exhibit elevated plasma concentrations of the glucose-mobilising pancreatic hormone glucagon; i.e. hyperglucagonaemia. This contributes to the hyperglycaemic state o...
Eligibility Criteria
Inclusion
- Normal fasting plasma glucose and glycated haemoglobin (HbA1c) \<42 mmol/mol
- Body mass index (BMI) between 18.5 and 25 kg/m2
- Haemoglobin \>8.3 mmol/l
- Habitual diet in accordance with the Nordic Nutrition Recommendations
- Age between 20 and 65 years
- Oral and written informed consent
Exclusion
- Diabetes
- First-degree relatives with diabetes
- Fasting plasma triacylglycerol indicating dyslipidemia (≥2 mmol/l)
- Nephropathy (estimated glomerular filtration rate (eGFR) \<60 ml/min and/or microalbuminuria with an albumin to creatinine ratio of 30-300 μg/mg)
- Known liver disease and/or alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) \>2 × normal values
- Signs of liver fibrosis and/or steatosis evaluated by FibroScan (CAP value \>2380 dB/m and/or kPa \>65.0) and/or FIB-4 score (\>1.45)
- \>5% steatosis evaluated by MRI carried out before experimental Day A (see Methods)
- Use of medication
- Use of dietary protein supplementation or any other dietary supplements that cannot be paused during participation
- Excessive training habits, defined as \>2 weekly strength and/or aerobic training sessions
- Pregnancy and/or breastfeeding
- Implanted metal objects incompatible with magnetic resonance imaging (MRI)
- Any condition that the investigator feels would interfere with trial completion
Key Trial Info
Start Date :
February 8 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 9 2021
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT04859322
Start Date
February 8 2021
End Date
December 9 2021
Last Update
May 11 2023
Active Locations (1)
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1
Center for Clinical Metabolic Research
Hellerup, Copenhagen, Denmark, 2900