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Involvement of Steatosis-induced Glucagon Resistance in Hyperglucagonaemia

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ClinicalTrials.gov Identifier: NCT02337660
Recruitment Status : Completed
First Posted : January 13, 2015
Last Update Posted : November 16, 2018
Sponsor:
Collaborator:
The Novo Nordisk Foundation Center for Basic Metabolic Research
Information provided by (Responsible Party):
Malte Palm Suppli, University Hospital, Gentofte, Copenhagen

Brief Summary:
The purpose of this study is to examine whether non-alcoholic fatty liver disease (NAFLD) is associated with hepatic glucagon resistance and hyperglucagonemia.

Condition or disease Intervention/treatment Phase
Non-alcoholic Fatty Liver Disease Procedure: Liver biopsy Other: Pancreatic clamp Not Applicable

Detailed Description:
Hyperglucagonemia is a common condition in obesity, prediabetes and type 2 diabetes. It increases the hepatic glucose production, thus contributing to type 2-diabetic hyperglycemia. In the current study we wish to examine whether non-alcoholic fatty disease (NAFLD) results in hepatic glucagon resistance. This could result in hyperglucagonemia through a feedback mechanism acting on the level of pancreatic alpha cells. Cirrhosis and type 1 diabetes, respectively, has previously been shown to be associated with hepatic glucagon resistance but it has not been examined in relation to NAFLD in humans so far.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Involvement of Steatosis-induced Glucagon Resistance in Hyperglucagonaemia
Study Start Date : January 2015
Actual Primary Completion Date : January 2016
Actual Study Completion Date : January 2016


Arm Intervention/treatment
Experimental: Healthy, lean

15 healthy, lean subjects.

Will have a liver biopsy, and on the experimental day a pancreatic clamp will be performed.

Procedure: Liver biopsy
One ultrasound guided liver biopsy

Other: Pancreatic clamp
I.v. infusions of somatostatin and insulin (basal rate) for will be adminstered for 3 hours. Glucagon will administered for 3 hours in total with infusion rates at a basal and a high physiological rate for 1.5 hours each.

Experimental: Obese, otherwise healthy

15 obese, otherwise healthy subjects

Will have a liver biopsy, and on the experimental day a pancreatic clamp will be performed.

Procedure: Liver biopsy
One ultrasound guided liver biopsy

Other: Pancreatic clamp
I.v. infusions of somatostatin and insulin (basal rate) for will be adminstered for 3 hours. Glucagon will administered for 3 hours in total with infusion rates at a basal and a high physiological rate for 1.5 hours each.




Primary Outcome Measures :
  1. Endogenous glucose production [ Time Frame: 0-180 min ]
  2. Amino acid metabolism [ Time Frame: 0-180 min ]

Secondary Outcome Measures :
  1. Degree of steatosis [ Time Frame: baseline ]
  2. Total RNA sequencing of liver biopsies [ Time Frame: baseline ]


Information from the National Library of Medicine

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Ages Eligible for Study:   25 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02337660


Locations
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Denmark
Center for Diabetes Research
Gentofte, Denmark, 2900
Sponsors and Collaborators
University Hospital, Gentofte, Copenhagen
The Novo Nordisk Foundation Center for Basic Metabolic Research
Publications:

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Responsible Party: Malte Palm Suppli, Research year assistant, University Hospital, Gentofte, Copenhagen
ClinicalTrials.gov Identifier: NCT02337660    
Other Study ID Numbers: SIRG-1
First Posted: January 13, 2015    Key Record Dates
Last Update Posted: November 16, 2018
Last Verified: November 2018
Additional relevant MeSH terms:
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Liver Diseases
Fatty Liver
Non-alcoholic Fatty Liver Disease
Digestive System Diseases