Non Alcoholic Fatty Liver DiseaseNCT01674972
Glucose-induced Glucagon-like Peptide 1 (GLP-1) Secretion in NAFLD Patients Compared to Healthy Controls
An observational study of Non Alcoholic Fatty Liver Disease and Non Alcoholic Steatohepatitis, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
Trial summary
The incretin effect is impaired in patients with type 2 diabetes mellitus (T2DM), thus GLP-1 receptor agonists are used for the treatment of T2DM. Insulin resistance is a pathophysiologic hallmark of non-alcoholic fatty liver disease (NAFLD). The incretin effect in patients with NAFLD has not been studied. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Non Alcoholic Fatty Liver Disease, Non Alcoholic Steatohepatitis
- What is being tested?
- Oral glucose tolerance test
- Type of treatment
- Pill or oral medicine
- How many people
- 102 participants
- Where
- 1 siteSwitzerland
- Study dates
- Jan 2011to Jun 2012
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients with biopsy proven NAFLD and NASH will be recruited from the Hepatology Outpatient Clinic, Division of Gastroenterology and Hepatology, University Hospital Basel. Healthy control subjects will be matched to NAFLD and NASH patients.
Who may be able to join
- Biopsy proven NAFLD or NASH
Who cannot join
- additional concomitants liver disease
- T2DM
- alcohol consumption >40g/d for male subjects and >20g/d for female subjects
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
University Hospital Basel, Division of Gastroenterology and Hepatology
Basel
About this study
The incretin effect is impaired in patients with type 2 diabetes mellitus (T2DM), thus GLP-1 receptor agonists are used for the treatment of T2DM. Insulin resistance is a pathophysiologic hallmark of non-alcoholic fatty liver disease (NAFLD). The incretin effect in patients with NAFLD has not been studied. The aim of this study is to quantify GLP-1 secretion in response to oral glucose tolerance test (oGTT) in patients with NAFLD compared to healthy controls. The results of this study will expand the knowledge of the pathophysiology of NAFLD and serve as a rational for potential future treatment strategies.
Read the detailed description
Primary endpoint: GLP-1 response to oral glucose Secondary endpoints: glucose and insulin responses to oral glucose challenge
- Being tested
- Oral glucose tolerance test
- Keywords
- NAFLD, NASH, GLP-1
- Medical subject headings
- Non-alcoholic Fatty Liver Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral glucose tolerance testOther
Oral intake of 75 g glucose after overnight fast
| Study group | Role | What they receive |
|---|---|---|
| NAFLD | Patients with biopsy proven NAFLD Receives: Other: Oral glucose tolerance test | |
| Control | Matched healthy control subjects Receives: Other: Oral glucose tolerance test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glucagon-like Peptide 1 (GLP-1) secretion in response to oGTT
The difference in GLP-1 secretion in response to oGTT as assessed by area under the curve (AUC) and peak plasma concentration (cmax) in patients with NAFLD compared to healthy controls.
Measured: 0, 15, 30, 60, 90, 120 min. after glucose administration
Secondary outcomes (1)
Insulin secretion and glucose curves in response to oGTT
Measured: 0, 15, 30, 60, 90, 120 min. after glucose administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2012 (estimated)
- Study startJan 2011
- Primary completionApr 2012
- Study completionJun 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non Alcoholic Fatty Liver DiseaseStudies of the same condition, open and under way.
- More trials run by University Hospital, Basel, SwitzerlandThe sponsor's other registered studies.
- 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Christoph Beglinger, MD, Principal investigator, University Hospital Basel, Division of Gastroenterology and Hepatology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01674972
- Sponsor's protocol ID
- EKBB 224/02.2
- Status last verified
- Aug 2012
- First submitted
- 24 Aug 2012
- Last updated
- 29 Aug 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Glucose-induced Glucagon-like Peptide 1 (GLP-1) Secretion in NAFLD Patients Compared to Healthy Controls
- ClinicalTrials.gov ID
- NCT01674972
- Acronym / sponsor ID
- EKBB 224/02.2
- Keywords
- NAFLD, NASH, GLP-1
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Study start
- Jan 2011
- Primary completion
- Apr 2012 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 29 Aug 2012 (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 incretin effect is impaired in patients with type 2 diabetes mellitus (T2DM), thus GLP-1 receptor agonists are used for the treatment of T2DM. Insulin resistance is a pathophysiologic hallmark of non-alcoholic fatty liver disease (NAFLD). The incretin effect in patients with NAFLD has not been studied. The aim of this study is to quantify GLP-1 secretion in response to oral glucose tolerance test (oGTT) in patients with NAFLD compared to healthy controls. The results of this study will expand the knowledge of the pathophysiology of NAFLD and serve as a rational for potential future treatment strategies.
Detailed description
Primary endpoint: GLP-1 response to oral glucose Secondary endpoints: glucose and insulin responses to oral glucose challenge
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NAFLD | – | Other: Oral glucose tolerance testPatients with biopsy proven NAFLD |
| Control | – | Other: Oral glucose tolerance testMatched healthy control subjects |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with biopsy proven NAFLD and NASH will be recruited from the Hepatology Outpatient Clinic, Division of Gastroenterology and Hepatology, University Hospital Basel. Healthy control subjects will be matched to NAFLD and NASH patients.
Key inclusion criteria (1 listed)
- Biopsy proven NAFLD or NASH
Key exclusion criteria (3 listed)
- additional concomitants liver disease
- T2DM
- alcohol consumption >40g/d for male subjects and >20g/d for female subjects
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 |
|---|---|---|
| Oral glucose tolerance testOral intake of 75 g glucose after overnight fast | Other | Control, NAFLD |
Primary outcome
Glucagon-like Peptide 1 (GLP-1) secretion in response to oGTT
Time frame: 0, 15, 30, 60, 90, 120 min. after glucose administration
The difference in GLP-1 secretion in response to oGTT as assessed by area under the curve (AUC) and peak plasma concentration (cmax) in patients with NAFLD compared to healthy controls.
1 secondary outcome
Insulin secretion and glucose curves in response to oGTT
Time frame: 0, 15, 30, 60, 90, 120 min. after glucose administration
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 29 Aug 2012.
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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.
Christoph Beglinger, MD principal investigator
University Hospital Basel, Division of Gastroenterology and Hepatology
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 Non Alcoholic Steatohepatitis, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
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 1 inclusion and 3 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 29 Aug 2012. 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 Switzerland. 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?
Glucagon-like Peptide 1 (GLP-1) secretion in response to oGTT (time frame: 0, 15, 30, 60, 90, 120 min. after glucose administration). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Aug 2012.