Involvement of Steatosis-induced Glucagon Resistance in Hyperglucagonaemia

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02337660
• Date of registration: 08/01/2015
• Prospective Registration: No
• Primary sponsor: University Hospital, Gentofte, Copenhagen
• Public title: Involvement of Steatosis-induced Glucagon Resistance in Hyperglucagonaemia
• Scientific title: Involvement of Steatosis-induced Glucagon Resistance in Hyperglucagonaemia
• Date of first enrolment: January 2015
• Target sample size: 30
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02337660
• Study type: Interventional
• Study design: Allocation: Non-Randomized. Intervention model: Parallel Assignment. Primary purpose: Basic Science. Masking: None (Open Label).
• Phase: N/A

Countries of recruitment

Denmark

Key inclusion & exclusion criteria

Inclusion Criteria:

- Normal fasting plasma glucose and HbA1c < 6.0%

- Between 18.5 and 25 kg/m2 or between 30 and 40 kg/m2

- Normal haemoglobin

- Normal coagulation factor II, VII and X, INR and thrombocytes

- Age above 25 years

- Informed consent

Exclusion Criteria:

- Diabetes

- Prediabetes (impaired glucose tolerance and/or impaired fasting plasma glucose)

- First-degree relatives with diabetes

- Nephropathy (eGFR < 60ml/min and/or albuminuria)

- Liver disease (ALAT and/or serum ASAT >2x normal values)

- Use of anticoagulative medicine like Clopidogrel og Warfarin

- Pregnancy and/or breastfeeding

- Age above 80 years

- Any condition that the investigator feels would interfere with trial participation



Age minimum: 25 Years
Age maximum: 80 Years
Gender: All

Health Condition(s) or Problem(s) studied

Non-alcoholic Fatty Liver Disease

Intervention(s)

Other: Pancreatic clamp

Procedure: Liver biopsy

Primary Outcome(s)

Amino acid metabolism [Time Frame: 0-180 min]

Endogenous glucose production [Time Frame: 0-180 min]

Secondary Outcome(s)

Degree of steatosis [Time Frame: baseline]

Total RNA sequencing of liver biopsies [Time Frame: baseline]

Secondary ID(s)

SIRG-1

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

The Novo Nordisk Foundation Center for Basic Metabolic Research