Diabetes MellitusNCT00732602
The Effects of GIP and GLP-2 on the Secretion of Glucagon in Patients With Type 1 Diabetes
A study testing GIP-infusion, Sodium-chloride and GLP-2 infusion in people with Diabetes Mellitus, run by University Hospital, Gentofte, Copenhagen at 1 site in Denmark.
Trial summary
The purpose of this study is to determine whether Glucose-dependent Insulinotropic Polypeptide (GIP) or Glucagon Like Peptide 2 (GLP-2) has an affect on the secretion of Glucagon from the pancreas in patients with type 1 diabetes mellitus. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Mellitus
- What is being tested?
- GIP-infusion, Sodium-chloride and GLP-2 infusion
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 8 participants
- Where
- 1 siteDenmark
- Study dates
- Jan 2008to Aug 2008
- Phase
- Interventional
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Caucasians over 18 years with type 1 diabetes (WHO criteria)
- Arginine test without rise in plasma C-peptide
- Normal blood Hemoglobin
- Informed consent
Who cannot join
- Liver disease
- Diabetic nephropathy
- Treatment with medications unpausable for 12 hours
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to determine whether Glucose-dependent Insulinotropic Polypeptide (GIP) or Glucagon Like Peptide 2 (GLP-2) has an affect on the secretion of Glucagon from the pancreas in patients with type 1 diabetes mellitus.
- Conditions
- Diabetes Mellitus
- Being tested
- GIP-infusion, Sodium-chloride, GLP-2 infusion
- Keywords
- Glucagon, Glucose-dependent Insulinotropic Polypeptide, Glucagon-Like peptide 2
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GIP-infusionOther
Sodium-chlorideOther
GLP-2 infusionOther
| Study group | Role | What they receive |
|---|---|---|
| B | Active comparator | GLP-2 infusion Receives: Other: GLP-2 infusion |
| C | Placebo comparator | Sodium-chloride infusion Receives: Other: Sodium-chloride |
| A | Active comparator | GIP-infusion Receives: Other: GIP-infusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
plasma-glucagon Area Under Curve at 0-90 min. and 90-180 min.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2008 (estimated)
- Study startJan 2008
- Primary completionAug 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes MellitusStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Gentofte, Copenhagen
- Sponsor type
- University, hospital or other
- Collaborators
- University of Copenhagen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00732602
- Sponsor's protocol ID
- H-D-2007-0058
- Status last verified
- Feb 2009
- First submitted
- 11 Aug 2008
- Last updated
- 13 Feb 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of GIP and GLP-2 on the Secretion of Glucagon in Patients With Type 1 Diabetes
- ClinicalTrials.gov ID
- NCT00732602
- Acronym / sponsor ID
- H-D-2007-0058
- Conditions
- Diabetes Mellitus
- Keywords
- Glucagon, Glucose-dependent Insulinotropic Polypeptide, Glucagon-Like peptide 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- University Hospital, Gentofte, CopenhagenUniversity, hospital or other
- Collaborators
- University of Copenhagen
- Study start
- Jan 2008
- Primary completion
- Aug 2008 (actual)
- First posted
- 12 Aug 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 purpose of this study is to determine whether Glucose-dependent Insulinotropic Polypeptide (GIP) or Glucagon Like Peptide 2 (GLP-2) has an affect on the secretion of Glucagon from the pancreas in patients with type 1 diabetes mellitus.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| B | Active comparator | Other: GLP-2 infusionGLP-2 infusion |
| C | Placebo comparator | Other: Sodium-chlorideSodium-chloride infusion |
| A | Active comparator | Other: GIP-infusionGIP-infusion |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Caucasians over 18 years with type 1 diabetes (WHO criteria)
- Arginine test without rise in plasma C-peptide
- Normal blood Hemoglobin
- Informed consent
Key exclusion criteria (3 listed)
- Liver disease
- Diabetic nephropathy
- Treatment with medications unpausable for 12 hours
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 |
|---|---|---|
| GIP-infusion | Other | A |
| Sodium-chloride | Other | C |
| GLP-2 infusion | Other | B |
Primary outcome
plasma-glucagon Area Under Curve at 0-90 min. and 90-180 min.
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 Feb 2009.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing GIP-infusion, Sodium-chloride and GLP-2 infusion in people with 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 4 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 Feb 2009. 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. Some participants in this study may receive a placebo. 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?
plasma-glucagon Area Under Curve at 0-90 min. and 90-180 min.. 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 13 Feb 2009.