Non Alcoholic Fatty Liver DiseaseNCT01492283
Pathophysiological Implications of the Incretin Hormones in Patients With Liver Disease With and Without Diabetes
An observational study of Non Alcoholic Fatty Liver Disease and Type 2 Diabetes, run by University Hospital, Gentofte, Copenhagen at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Non Alcoholic Fatty Liver Disease, Type 2 Diabetes, Liver Cirrhosis
- What is being tested?
- OGTT and IIGI
- Type of treatment
- Injection or infusion
- How many people
- 48 participants
- Where
- 1 siteDenmark
- Study dates
- Dec 2011to Jul 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: 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
Who may be able to join
None listed.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Diabetes Research Division, Gentofte University Hospital, Niels Andersens Vej 65, opgang 4b, 1. sal
Hellerup, 2900
About this study
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.
Read the 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.
- Being tested
- OGTT, IIGI
- Keywords
- NAFLD, Incretin hormones
- Medical subject headings
- Non-alcoholic Fatty Liver Disease, Diabetes Mellitus, Type 2, Liver Cirrhosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OGTTOther
Also called Waterfree glucose, The Pharmacy of the capital region
50g waterfree glucose dissolved in 300 ml water consumed over 5 min.
IIGIOther
Also called Glucose infusion, 20%
iso glycemic intravenous (iv) glucose infusion (IIGI) with 20% glucose
| Study group | Role | What they receive |
|---|---|---|
| NAFLD | Non alcoholic fatty liver disease without type 2 diabetes Receives: Other: OGTT; Other: IIGI | |
| NAFLD+T2D | Non alcoholic fatty liver disease with type 2 diabetes Receives: Other: OGTT; Other: IIGI | |
| T2D | Type 2 diabetics without non alcoholic fatty liver disease Receives: Other: OGTT; Other: IIGI | |
| cirrhosis | Patients with liver cirrhosis Receives: Other: OGTT; Other: IIGI | |
| Kontrol groups | Healthy control subjects Receives: Other: OGTT; Other: IIGI |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Incretin effect
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
Measured: pre dose 0,10, 20, 30, 40, 50, 60, 75, 90, 120, 150, 180, 240 min post dose
Secondary outcomes (3)
Plasma Glucagon like peptide 1 (GLP-1) response
Comparing GLP-1 responses of the different experimental days, compared to healthy control subjects.
Measured: pre dose 0,10, 20, 30, 40, 50, 60, 75, 90, 120, 150, 180, 240 min post dose
Plasma Glucose-dependent insulinotropic peptide (GIP) response
Comparing GIP responses of the different experimental days, compared to healthy control subjects.
Measured: pre dose 0,10, 20, 30, 40, 50, 60, 75, 90, 120, 150, 180, 240 min post dose
Plasma glucagon response
Comparing glucagon responses of the different experimental days, compared to healthy control subjects.
Measured: pre dose 0,10, 20, 30, 40, 50, 60, 75, 90, 120, 150, 180, 240 min post dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2011 (estimated)
- Study startDec 2011
- Primary completionMay 2013
- Study completionJul 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Non Alcoholic Fatty Liver DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Gentofte, Copenhagen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jonatan I Bagger, University Hospital, Gentofte, Copenhagen
- Investigators
- Anders E Junker, MD, phd-student, Principal investigator, Diabetes Research Division, Gentofte Hospital, University of Copenhagen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01492283
- Sponsor's protocol ID
- LINK-1-2011
- Other IDs
- H-1-2011-082
- Status last verified
- Jul 2014
- First submitted
- 5 Dec 2011
- Last updated
- 10 Jul 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 38035766Maagensen 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.
PubMed 29506157
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pathophysiological Implications of the Incretin Hormones in Patients With Liver Disease With and Without Diabetes
- ClinicalTrials.gov ID
- NCT01492283
- Acronym / sponsor ID
- LINK-1-2011
- Keywords
- NAFLD, Incretin hormones
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- University Hospital, Gentofte, CopenhagenUniversity, hospital or other
- Study start
- Dec 2011
- Primary completion
- May 2013 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 14 Dec 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| NAFLD | – | Other: OGTT, Other: IIGINon alcoholic fatty liver disease without type 2 diabetes |
| NAFLD+T2D | – | Other: OGTT, Other: IIGINon alcoholic fatty liver disease with type 2 diabetes |
| T2D | – | Other: OGTT, Other: IIGIType 2 diabetics without non alcoholic fatty liver disease |
| cirrhosis | – | Other: OGTT, Other: IIGIPatients with liver cirrhosis |
| Kontrol groups | – | Other: OGTT, Other: IIGIHealthy control subjects |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 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
Key inclusion criteria (0 listed)
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OGTTAlso: Waterfree glucose, The Pharmacy of the capital region50g waterfree glucose dissolved in 300 ml water consumed over 5 min. | Other | Kontrol groups, NAFLD, NAFLD+T2D, T2D, cirrhosis |
| IIGIAlso: Glucose infusion, 20%iso glycemic intravenous (iv) glucose infusion (IIGI) with 20% glucose | Other | Kontrol groups, NAFLD, NAFLD+T2D, T2D, cirrhosis |
Primary outcome
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
3 secondary outcomes
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
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
Plasma glucagon response
Time frame: pre dose 0,10, 20, 30, 40, 50, 60, 75, 90, 120, 150, 180, 240 min post dose
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2014.
- Derived from this study: PubMed 38035766Lauritsen 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.
- Derived from this study: PubMed 29506157Maagensen 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anders E Junker, MD, phd-student principal investigator
Diabetes Research Division, Gentofte Hospital, University of Copenhagen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Non Alcoholic Fatty Liver Disease and Type 2 Diabetes, run by University Hospital, Gentofte, Copenhagen at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01492283, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jul 2014.