Short Bowel SyndromeNCT00673751
Effect of the Enteric Hormone Glucagon-Like Peptide (GLP-2) on the Intestinal Blood Flow in Patients With Short Bowel Syndrome
A study testing GLP-2 in people with Short Bowel Syndrome, run by Glostrup University Hospital, Copenhagen at 1 site in Denmark.
Trial summary
The aim of the study is to investigate the effect of the enteric hormone Glucagon-like Peptide (GLP-2) on patients with short bowel syndrome Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Short Bowel Syndrome
- What is being tested?
- GLP-2
- 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
- Start not givento not given
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- clinical diagnose of short bowel syndrome 4 month of stable fase
Who cannot join
- activity in IBD
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Glostrup University Hospital
Glostrup Municipality, Capital Region, 2600
About this study
Official title: GLP-2 Mediated Increased SMA Blood Flow in Patients With Short Bowel Syndrome
The aim of the study is to investigate the effect of the enteric hormone Glucagon-like Peptide (GLP-2) on patients with short bowel syndrome
Read the detailed description
previous studies have shown that GLP-2 increases mesenteric blow flow, we wish to examine the effect of subcutaneus GLP-2 on patients with short bowl syndrome. The patients will single blinded been given 450 nmol GLP-2 and isotonic saline in order to act as their own reference.
- Conditions
- Short Bowel Syndrome
- Being tested
- GLP-2, Placebo
- Keywords
- mesenteric blood flow, GLP-2, short bowel syndrome, Glucagon-Like Peptide 2
- Medical subject headings
- Short Bowel Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GLP-2Drug
450 nmol subcutaneous
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| 2 | Placebo comparator | subcutaneous isotonic saline Receives: Drug: Placebo |
| 1 | Active comparator | subcutaneous GLP-2 Receives: Drug: GLP-2 |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2008 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Short Bowel SyndromeStudies 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
- 8 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Glostrup University Hospital, Copenhagen
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00673751
- Sponsor's protocol ID
- H-A-2008-032
- Status last verified
- May 2008
- First submitted
- 5 May 2008
- Last updated
- 7 May 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- GLP-2 Mediated Increased SMA Blood Flow in Patients With Short Bowel Syndrome
- ClinicalTrials.gov ID
- NCT00673751
- Acronym / sponsor ID
- H-A-2008-032
- Conditions
- Short Bowel Syndrome
- Keywords
- mesenteric blood flow, GLP-2, short bowel syndrome, Glucagon-Like Peptide 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 8 participants (estimated)
- Lead sponsor
- Glostrup University Hospital, CopenhagenUniversity, hospital or other
- First posted
- 7 May 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 aim of the study is to investigate the effect of the enteric hormone Glucagon-like Peptide (GLP-2) on patients with short bowel syndrome
Detailed description
previous studies have shown that GLP-2 increases mesenteric blow flow, we wish to examine the effect of subcutaneus GLP-2 on patients with short bowl syndrome. The patients will single blinded been given 450 nmol GLP-2 and isotonic saline in order to act as their own reference.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 2 | Placebo comparator | Drug: Placebosubcutaneous isotonic saline |
| 1 | Active comparator | Drug: GLP-2subcutaneous GLP-2 |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- clinical diagnose of short bowel syndrome 4 month of stable fase
Key exclusion criteria (1 listed)
- activity in IBD
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 |
|---|---|---|
| GLP-2450 nmol subcutaneous | Drug | 1 |
| Placebo | Drug | 2 |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2008.
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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 GLP-2 in people with Short Bowel Syndrome, 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 1 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: status not confirmed, as of the sponsor's last update on 7 May 2008. 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?
Results are not available in the source record.
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 7 May 2008.