Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Jonatan I Bagger, University Hospital, Gentofte, Copenhagen
ClinicalTrials.gov Identifier:
NCT01492283
First received: December 5, 2011
Last updated: July 9, 2014
Last verified: July 2014

December 5, 2011
July 9, 2014
December 2011
May 2013   (final data collection date for primary outcome measure)
The Incretin effect [ Time Frame: pre dose 0,10, 20, 30, 40, 50, 60, 75, 90, 120, 150, 180, 240 min post dose ] [ Designated as safety issue: No ]
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
The Incretin effect [ Time Frame: pre dose 0,10, 20, 30, 40, 50, 60, 75, 90, 120, 150, 180, 240 min post dose ] [ Designated as safety issue: No ]
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: OGTT and isoglycemic iv glucose infusion in NAFLD patients with and without diabetes, and cirrhotic patients compared to healthy control subjects
Complete list of historical versions of study NCT01492283 on ClinicalTrials.gov Archive Site
  • 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 ] [ Designated as safety issue: No ]
    Comparing GLP-1 responses of the different experimental days, compared to healthy control subjects.
  • 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 ] [ Designated as safety issue: No ]
    Comparing GIP responses of the different experimental days, compared to healthy control subjects.
  • Plasma glucagon response [ Time Frame: pre dose 0,10, 20, 30, 40, 50, 60, 75, 90, 120, 150, 180, 240 min post dose ] [ Designated as safety issue: No ]
    Comparing glucagon responses of the different experimental days, compared to healthy control subjects.
  • Plasma GLP1 response [ Time Frame: pre dose 0,10, 20, 30, 40, 50, 60, 75, 90, 120, 150, 180, 240 min post dose ] [ Designated as safety issue: No ]
    Comparing GLP-1 responses of the different experimental days, compared to healthy control subjects.
  • Plasma GIP response [ Time Frame: pre dose 0,10, 20, 30, 40, 50, 60, 75, 90, 120, 150, 180, 240 min post dose ] [ Designated as safety issue: No ]
    Comparing GIP responses of the different experimental days, compared to healthy control subjects.
  • Plasma glucagon response [ Time Frame: pre dose 0,10, 20, 30, 40, 50, 60, 75, 90, 120, 150, 180, 240 min post dose ] [ Designated as safety issue: No ]
    Comparing glucagon responses of the different experimental days, compared to healthy control subjects.
Not Provided
Not Provided
 
Pathophysiological Implications of the Incretin Hormones in Patients With Liver Disease With and Without Diabetes
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.

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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:

DNA (whole blood) will be kept for 15 years

Non-Probability Sample

Patients with NAFLD and liver cirrhosis confirmed by liver biopsy, and patients with or without well characterized type 2 diabetes recruited in the the hospitals out patients clinic

  • Non Alcoholic Fatty Liver Disease
  • Type 2 Diabetes
  • Liver Cirrhosis
  • Other: OGTT
    50g waterfree glucose dissolved in 300 ml water consumed over 5 min.
    Other Name: Waterfree glucose, The Pharmacy of the capital region
  • Other: IIGI
    iso glycemic intravenous (iv) glucose infusion (IIGI) with 20% glucose
    Other Name: Glucose infusion, 20%
  • NAFLD
    Non alcoholic fatty liver disease without type 2 diabetes
    Interventions:
    • Other: OGTT
    • Other: IIGI
  • NAFLD+T2D
    Non alcoholic fatty liver disease with type 2 diabetes
    Interventions:
    • Other: OGTT
    • Other: IIGI
  • T2D
    Type 2 diabetics without non alcoholic fatty liver disease
    Interventions:
    • Other: OGTT
    • Other: IIGI
  • cirrhosis
    Patients with liver cirrhosis
    Interventions:
    • Other: OGTT
    • Other: IIGI
  • Kontrol groups
    Healthy control subjects
    Interventions:
    • Other: OGTT
    • Other: IIGI
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
48
July 2014
May 2013   (final data collection date for primary outcome measure)

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
Both
18 Years to 80 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Denmark
 
NCT01492283
LINK-1-2011, H-1-2011-082
Yes
Jonatan I Bagger, University Hospital, Gentofte, Copenhagen
University Hospital, Gentofte, Copenhagen
Not Provided
Principal Investigator: Anders E Junker, MD, phd-student Diabetes Research Division, Gentofte Hospital, University of Copenhagen
University Hospital, Gentofte, Copenhagen
July 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP