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NCT Number: NCT01492283

Pathophysiological Implications of the Incretin Hormones in Patients With Liver Disease With and Without Diabetes

The main objective of this study is to analyze the pathophysiological implications of glucagon and the incretin hormones in patients with liver disease (Non alcoholic fatty liver disease (NAFLD) or cirrhosis) with and without diabetes compared with healthy controls. The present study will contribute significantly to the understanding of the pathophysiology of liver disease and glucose metabolism. The final goal is that the results could pave the way for new treatment modalities for patients with liver disease.

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Key information

Conditions

Non Alcoholic Fatty Liver Disease Diabetes Mellitus Diabetes Mellitus, Type 2 Digestive System Diseases Endocrine System Diseases Fatty Liver Fibrosis Glucose Metabolism Disorders Liver Cirrhosis Liver Diseases Metabolic Diseases Non-alcoholic Fatty Liver Disease Nutritional and Metabolic Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Type 2 Diabetes

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Diabetes Research Division, Gentofte University Hospital, Niels Andersens Vej 65, opgang 4b, 1. sal

Hellerup, 2900, Denmark

About this study

Comparison of of insulin secretion (Area Under the Curve (AUC)) during the experimental days. Furthermore a comparison of GIP, GLP1 and glucagon responses as well as plasma glucose levels.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

I) Group 1: NAFLD patients with normal glucose tolerance Inclusion criteria

  • NAFLD verified by a liver biopsy
  • Caucasian >18 years of age
  • Negative islet cell (ICA) and glutamic acid decarboxylase 65 (GAD65) autoantibodies
  • Normal 75-g OGTT as specified in the WHO Criteria
  • Normal haemoglobin and blood pressure (BP)
  • Written informed consent

II) Group 2: NAFLD patients with type 2 diabetes Inclusion criteria

  • NAFLD verified by liver biopsy
  • T2DM according to the WHO Criteria
  • Caucasian >18 years of age
  • Negative ICA and GAD65, normal haemoglobin, normal BP
  • Written informed consent

III) Group 3: NAFLD patients without type 2 diabetes Inclusion criteria

  • NAFLD verified by liver biopsy
  • Caucasian >18 years of age
  • Normal 75-g OGTT
  • Negative ICA and GAD65-autoantibodies
  • Normal haemoglobin and BP
  • Written informed consent

IV) Group 4: Cirrhosis with or without type 2 diabetes Inclusion criteria

  • Liver cirrhosis verified by liver biopsy
  • Caucasian > 18 years of age
  • Negative ICA and GAD65-autoantibodies
  • Normal haemoglobin and BP
  • Written informed consent

V) Group 5: Healthy controls Inclusion criteria

  • Caucasian >18 years of age
  • Normal 75-g OGTT according to the WHO Criteria
  • Negative ICA and GAD65-autoantibodies
  • Normal haemoglobin and BP
  • Written informed consent

Exclusion criteria

(all groups)

  • Other known liver disease - viral hepatitis, hereditary haemochromatosis, autoimmune liver disease, alpha-1 trypsin deficiency, Wilson disease, drug induced liver Injury (DILI)
  • Treatment with medications that cannot be discontinued for 12 hours
  • Unwillingness to participate in protocols
  • Pregnancy or lactation

Treatment and study plan

OGTT

Other

50g waterfree glucose dissolved in 300 ml water consumed over 5 min.

Other names: Waterfree glucose, The Pharmacy of the capital region

IIGI

Other

iso glycemic intravenous (iv) glucose infusion (IIGI) with 20% glucose

Other names: Glucose infusion, 20%

Primary outcomes

  1. The Incretin effect

    Time frame: pre dose 0,10, 20, 30, 40, 50, 60, 75, 90, 120, 150, 180, 240 min post dose

    The difference in insulin responses, as assessed by the area under curve (AUC) for plasma insulin and C-peptide concentrations, during the two different glucose stimuli: Oral glucose tolerance test (OGTT) and isoglycemic iv glucose infusion in NAFLD patients with and without diabetes, and cirrhotic patients compared to healthy control subjects

Secondary outcomes

  1. Plasma Glucagon like peptide 1 (GLP-1) response

    Time frame: pre dose 0,10, 20, 30, 40, 50, 60, 75, 90, 120, 150, 180, 240 min post dose

    Comparing GLP-1 responses of the different experimental days, compared to healthy control subjects.

  2. Plasma Glucose-dependent insulinotropic peptide (GIP) response

    Time frame: pre dose 0,10, 20, 30, 40, 50, 60, 75, 90, 120, 150, 180, 240 min post dose

    Comparing GIP responses of the different experimental days, compared to healthy control subjects.

  3. Plasma glucagon response

    Time frame: pre dose 0,10, 20, 30, 40, 50, 60, 75, 90, 120, 150, 180, 240 min post dose

    Comparing glucagon responses of the different experimental days, compared to healthy control subjects.

Sponsors and collaborators

Lead sponsor

University Hospital, Gentofte, Copenhagen

Other

Registry information

Important dates

Study start
2011
Primary completion
2013
Study completion
2014
First posted
Dec 14, 2011
Registry last updated
Jul 10, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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