Chronic PancreatitisNCT00638573
The Incretin Effect in Patients With Chronic Pancreatitis
An observational study of Chronic Pancreatitis and Type 2 Diabetes Mellitus, run by University Hospital, Gentofte, Copenhagen at 1 site in Denmark.
Trial summary
The phenomenon that oral glucose elicits a higher insulin response than does intravenous (iv) glucose, even at identical plasma glucose (PG) profiles (isoglycemia), is called the incretin effect. In type 2 diabetes mellitus (T2DM) the incretin effect has been shown to be markedly reduced or even abolished. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Pancreatitis, Type 2 Diabetes Mellitus
- How many people
- 32 participants
- Where
- 1 siteDenmark
- Study dates
- Jan 2006to Jul 2006
- 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 chronic pancreatitis with and without secondary diabetes mellitus
Who may be able to join
- Diagnosis of chronic pancreatitis with secondary diabetes mellitus
- Diagnosis of chronic pancreatitis with normal glucose tolerance
- Diagnosis of type 2 diabetes
- Normal level of hemoglobin
- Normal level of se-creatinine
Who cannot join
- GAD-65 autoantibodies
- ICA autoantibodies
- Albuminuria
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Incretin Effect in Patients With Chronic Pancreatitis With and Without Secondary Diabetes Mellitus
The phenomenon that oral glucose elicits a higher insulin response than does intravenous (iv) glucose, even at identical plasma glucose (PG) profiles (isoglycemia), is called the incretin effect. In type 2 diabetes mellitus (T2DM) the incretin effect has been shown to be markedly reduced or even abolished. It is not known whether the reduced incretin effect in T2DM is a primary event leading to T2DM or if it is merely a consequence of the diabetic state. To answer this question the investigators plan to estimate the incretin effect in 8 patients with secondary diabetes mellitus (DM) to chronic pancreatitis (CP) and compare it to the incretin effect of 8 patients with CP and normal glucose tolerance (NGT). Eight patients with T2DM and 8 healthy control subjects are studied for comparison. The incretin effect is measured by a 50-g oral glucose tolerance test and an isoglycemic intravenous glucose infusion.
- Conditions
- Chronic Pancreatitis, Type 2 Diabetes Mellitus
- Medical subject headings
- Pancreatitis, Chronic, Diabetes Mellitus, Type 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2008 (estimated)
- Study startJan 2006
- Study completionJul 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic PancreatitisStudies 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
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Gentofte, Copenhagen
- Sponsor type
- University, hospital or other
- Collaborators
- University of Copenhagen
- Investigators
- Filip K Knop, MD, Principal investigator, University of CopenhagenJens J Holst, MD DMSc, Study director, University of CopenhagenThure Krarup, MD DMSc, Study director, Gentofte University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00638573
- Sponsor's protocol ID
- KA04034
- Status last verified
- Mar 2008
- First submitted
- 12 Mar 2008
- Last updated
- 13 Jan 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Incretin Effect in Patients With Chronic Pancreatitis With and Without Secondary Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT00638573
- Acronym / sponsor ID
- KA04034
- Conditions
- Chronic Pancreatitis, Type 2 Diabetes Mellitus
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- University Hospital, Gentofte, CopenhagenUniversity, hospital or other
- Collaborators
- University of Copenhagen
- Study start
- Jan 2006
- Study completion
- Jul 2006
- First posted
- 19 Mar 2008 (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 phenomenon that oral glucose elicits a higher insulin response than does intravenous (iv) glucose, even at identical plasma glucose (PG) profiles (isoglycemia), is called the incretin effect. In type 2 diabetes mellitus (T2DM) the incretin effect has been shown to be markedly reduced or even abolished. It is not known whether the reduced incretin effect in T2DM is a primary event leading to T2DM or if it is merely a consequence of the diabetic state. To answer this question the investigators plan to estimate the incretin effect in 8 patients with secondary diabetes mellitus (DM) to chronic pancreatitis (CP) and compare it to the incretin effect of 8 patients with CP and normal glucose tolerance (NGT). Eight patients with T2DM and 8 healthy control subjects are studied for comparison. The incretin effect is measured by a 50-g oral glucose tolerance test and an isoglycemic intravenous glucose infusion.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with chronic pancreatitis with and without secondary diabetes mellitus
Key inclusion criteria (5 listed)
- Diagnosis of chronic pancreatitis with secondary diabetes mellitus
- Diagnosis of chronic pancreatitis with normal glucose tolerance
- Diagnosis of type 2 diabetes
- Normal level of hemoglobin
- Normal level of se-creatinine
Key exclusion criteria (3 listed)
- GAD-65 autoantibodies
- ICA autoantibodies
- Albuminuria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
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 13 Jan 2010.
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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.
Filip K Knop, MD principal investigator
University of Copenhagen
Jens J Holst, MD DMSc study director
University of Copenhagen
Thure Krarup, MD DMSc study director
Gentofte University Hospital
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 Chronic Pancreatitis and Type 2 Diabetes Mellitus, 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 5 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 13 Jan 2010. 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.
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 13 Jan 2010.