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

NCT ID: NCT01492283

Last Updated: 2014-07-10

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 48 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2011-12-31
• Study Completion Date: 2014-07-31

Brief Summary

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.

Detailed Description

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.

Conditions

Non Alcoholic Fatty Liver Disease; Type 2 Diabetes; Liver Cirrhosis

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

NAFLD

Non alcoholic fatty liver disease without type 2 diabetes

OGTT

Intervention Type: OTHER

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

IIGI

Intervention Type: OTHER

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

NAFLD+T2D

Non alcoholic fatty liver disease with type 2 diabetes

OGTT

Intervention Type: OTHER

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

IIGI

Intervention Type: OTHER

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

T2D

Type 2 diabetics without non alcoholic fatty liver disease

OGTT

Intervention Type: OTHER

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

IIGI

Intervention Type: OTHER

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

cirrhosis

Patients with liver cirrhosis

OGTT

Intervention Type: OTHER

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

IIGI

Intervention Type: OTHER

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

Kontrol groups

Healthy control subjects

OGTT

Intervention Type: OTHER

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

IIGI

Intervention Type: OTHER

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

Interventions

OGTT

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

Intervention Type: OTHER

IIGI

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

Intervention Type: OTHER

Other Intervention Names

Waterfree glucose, The Pharmacy of the capital region; Glucose infusion, 20%

Eligibility Criteria

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

• 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

• 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

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

• 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

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University Hospital, Gentofte, Copenhagen

OTHER

Sponsor Role: lead

Responsible Party

Jonatan I Bagger

MD PhD-student

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Anders E Junker, MD, phd-student

Role: PRINCIPAL_INVESTIGATOR

Diabetes Research Division, Gentofte Hospital, University of Copenhagen

Locations

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

Hellerup, , Denmark

Countries

Denmark

References

Lauritsen JV, Bergmann N, Junker AE, Gyldenlove M, Skov L, Gluud LL, Hartmann B, Holst JJ, Vilsboll T, Knop FK. Oral glucose has little or no effect on appetite and satiety sensations despite a significant gastrointestinal response. Eur J Endocrinol. 2023 Dec 6;189(6):619-626. doi: 10.1093/ejendo/lvad161.

Reference Type: DERIVED

PMID: 38035766 (View on PubMed)

Maagensen H, Junker AE, Jorgensen NR, Gluud LL, Knop FK, Vilsboll T. Bone Turnover Markers in Patients With Nonalcoholic Fatty Liver Disease and/or Type 2 Diabetes During Oral Glucose and Isoglycemic Intravenous Glucose. J Clin Endocrinol Metab. 2018 May 1;103(5):2042-2049. doi: 10.1210/jc.2018-00176.

Reference Type: DERIVED

PMID: 29506157 (View on PubMed)

Other Identifiers

H-1-2011-082

Identifier Type: OTHER

Identifier Source: secondary_id

LINK-1-2011

Identifier Type: -

Identifier Source: org_study_id