Regional Blood FlowNCT00540215
GLP-2 (Glucagonlike Peptide-2) and Blood Flow
A study testing Glucagonlike peptide in people with Regional Blood Flow, run by Glostrup University Hospital, Copenhagen at 1 site in Denmark.
Trial summary
It is the study aim to investigate the effect of glp-2 on blood flow in humans. we wish to study eventual changes in renal blood flow, carotic blood flow and cardiac out put. GLP-2 will be administered subcutaneously, and the effect monitored by doppler ultra sound scannings and cotinuesly measuring of cardiac out put… Read more about this study
- Who is it for?
- Ages 20 to 60 years
- Conditions the study is for
- Regional Blood Flow
- What is being tested?
- Glucagonlike peptide
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 15 participants
- Where
- 1 siteDenmark
- Study dates
- Oct 2007to Feb 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 20 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age 20-60
- Healthy
- No medication
- Not pregnant
Who cannot join
- All of the persons not meeting the abowe mentioned criteria
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Glostrup University Hospital
Glostrup Municipality, Capital Region, 2600
About this study
Official title: The Role of GLP-2 in Univercal Changes in Blood Flow in Humans
It is the study aim to investigate the effect of glp-2 on blood flow in humans. we wish to study eventual changes in renal blood flow, carotic blood flow and cardiac out put.
GLP-2 will be administered subcutaneously, and the effect monitored by doppler ultra sound scannings and cotinuesly measuring of cardiac out put and blood pressure.
The study will include 15 healhty volunteers, 10 wil receive 450 nmol GLP-2 and 5 will receive 1 ml of isotonic saline (as baseline reference).
Read the detailed description
se the above
- Conditions
- Regional Blood Flow
- Being tested
- Glucagonlike peptide
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Glucagonlike peptideOther
450 nmol native form, synthetic
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | 450 nmol GLP-2 SC Receives: Other: Glucagonlike peptide |
| 2 | Placebo comparator | 1 ml isotonic saline SC Receives: Other: Glucagonlike peptide |
What is being measured
The primary outcome is the main question the study is designed to answer.
effect of glp-2
Measured: during study
Secondary outcomes (1)
potential new ideas for further studies
Measured: months to years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2007 (estimated)
- Study startOct 2007
- Primary completionJan 2008
- Study completionFeb 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Regional Blood FlowStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Glostrup University Hospital, Copenhagen
- Sponsor type
- University, hospital or other
- Investigators
- lasse bremholm, MD, Principal investigator, Glostrup university hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00540215
- Sponsor's protocol ID
- H-D-2007-0050
- Status last verified
- Oct 2007
- First submitted
- 4 Oct 2007
- Last updated
- 11 Feb 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of GLP-2 in Univercal Changes in Blood Flow in Humans
- ClinicalTrials.gov ID
- NCT00540215
- Acronym / sponsor ID
- H-D-2007-0050
- Conditions
- Regional Blood Flow
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Glostrup University Hospital, CopenhagenUniversity, hospital or other
- Study start
- Oct 2007
- Primary completion
- Jan 2008 (actual)
- Study completion
- Feb 2008 (actual)
- First posted
- 5 Oct 2007 (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.
It is the study aim to investigate the effect of glp-2 on blood flow in humans. we wish to study eventual changes in renal blood flow, carotic blood flow and cardiac out put.
GLP-2 will be administered subcutaneously, and the effect monitored by doppler ultra sound scannings and cotinuesly measuring of cardiac out put and blood pressure.
The study will include 15 healhty volunteers, 10 wil receive 450 nmol GLP-2 and 5 will receive 1 ml of isotonic saline (as baseline reference).
Detailed description
se the above
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Other: Glucagonlike peptide450 nmol GLP-2 SC |
| 2 | Placebo comparator | Other: Glucagonlike peptide1 ml isotonic saline SC |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Age 20-60
- Healthy
- No medication
- Not pregnant
Key exclusion criteria (1 listed)
- All of the persons not meeting the abowe mentioned criteria
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 |
|---|---|---|
| Glucagonlike peptide450 nmol native form, synthetic | Other | 1, 2 |
Primary outcome
effect of glp-2
Time frame: during study
1 secondary outcome
potential new ideas for further studies
Time frame: months to years
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 11 Feb 2011.
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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.
lasse bremholm, MD principal investigator
Glostrup university hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Glucagonlike peptide in people with Regional Blood Flow, run by Glostrup University Hospital, 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 1 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 11 Feb 2011. 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?
effect of glp-2 (time frame: during study). 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 11 Feb 2011.