GLP-2 (Glucagonlike Peptide-2) and Blood Flow | NCT00540215

Studies
GLP-2 (Glucagonlike Peptide-2) and Blood Flow

NCT00540215

Sponsor

Glostrup University Hospital, Copenhagen

Status

Completed

Last Update Posted

Feb 11, 2011Estimated

Enrollment

15Actual

Phase

Not Applicable

Conditions

Regional Blood Flow

Interventions

Glucagonlike peptide

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

Oct 2007

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2007

Primary Completion Date

Jan 2008Actual

Completion Date

Feb 2008Actual

First Submitted Date

Oct 4, 2007

First Submission Date that Met QC Criteria

Oct 4, 2007

First Posted Date

Oct 5, 2007Estimated

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

Feb 10, 2011

Last Update Posted Date

Feb 11, 2011Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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

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

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

15Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Active Comparator	450 nmol GLP-2 SC	Other: Glucagonlike peptide
2	Placebo Comparator	1 ml isotonic saline SC	Other: Glucagonlike peptide

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Glucagonlike peptide	Other	450 nmol native form, synthetic	1 2

Measure	Description	Time Frame
effect of glp-2		during study

Measure	Description	Time Frame
potential new ideas for further studies		months to years

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age 20-60
Healthy
No medication
Not pregnant

Exclusion Criteria:

All of the persons not meeting the abowe mentioned criteria

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

60 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
lasse bremholm, MD	Glostrup university hospital	Principal Investigator

Locations

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