Effect of the Enteric Hormone Glucagon-Like Peptide (GLP-... | NCT00673751

Studies
Effect of the Enteric Hormone Glucagon-Like Peptide (GLP-2) on the Intestinal Blood Flow in Patients With Short Bowel Syndrome

NCT00673751

Sponsor

Glostrup University Hospital, Copenhagen

Status

Unknown status

Last Update Posted

May 7, 2008Estimated

Enrollment

8Estimated

Phase

Not Applicable

Conditions

Short Bowel Syndrome

Interventions

GLP-2
Placebo

Countries

Denmark

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2008

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Enrolling by invitation

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Not provided

Primary Completion Date

Not provided

Completion Date

Not provided

First Submitted Date

May 5, 2008

First Submission Date that Met QC Criteria

May 6, 2008

First Posted Date

May 7, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 6, 2008

Last Update Posted Date

May 7, 2008Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

8Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
2	Placebo Comparator	subcutaneous isotonic saline	Drug: Placebo
1	Active Comparator	subcutaneous GLP-2	Drug: GLP-2

Interventions

Name	Type	Description	Arm Group Labels	Other Names
GLP-2	Drug	450 nmol subcutaneous	1
Placebo

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

clinical diagnose of short bowel syndrome 4 month of stable fase

Exclusion Criteria:

activity in IBD

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Glostrup University Hospital		Glostrup Municipality	Capital Region	2600	Denmark

Condition Browse Module

MeSH Terms

ID	Term
D012778	Short Bowel Syndrome

Ancestor Terms

ID	Term
D008286	Malabsorption Syndromes
D007410	Intestinal Diseases
D005767	Gastrointestinal Diseases
D004066	Digestive System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided