The Effects of GIP and GLP-2 on the Secretion of Glucagon... | NCT00732602

Studies
The Effects of GIP and GLP-2 on the Secretion of Glucagon in Patients With Type 1 Diabetes

NCT00732602

Sponsor

University Hospital, Gentofte, Copenhagen

Status

Completed

Last Update Posted

Feb 13, 2009Estimated

Enrollment

8Actual

Phase

Not Applicable

Conditions

Diabetes Mellitus

Interventions

GIP-infusion
Sodium-chloride
GLP-2 infusion

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

Feb 2009

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

Jan 2008

Primary Completion Date

Aug 2008Actual

Completion Date

Not provided

First Submitted Date

Aug 11, 2008

First Submission Date that Met QC Criteria

Aug 11, 2008

First Posted Date

Aug 12, 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

Feb 12, 2009

Last Update Posted Date

Feb 13, 2009Estimated

Name	Class
University of Copenhagen	OTHER

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 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.

Detailed Description

Not provided

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

8Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
B	Active Comparator	GLP-2 infusion	Other: GLP-2 infusion
C	Placebo Comparator	Sodium-chloride infusion	Other: Sodium-chloride
A	Active Comparator	GIP-infusion	Other: GIP-infusion

Interventions

Name	Type	Description	Arm Group Labels	Other Names
GIP-infusion	Other		A
Sodium-chloride

Measure	Description	Time Frame
plasma-glucagon Area Under Curve at 0-90 min. and 90-180 min.

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Caucasians over 18 years with type 1 diabetes (WHO criteria)
Arginine test without rise in plasma C-peptide
Normal blood Hemoglobin
Informed consent

Exclusion Criteria:

Liver disease
Diabetic nephropathy
Treatment with medications unpausable for 12 hours

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

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
University Hospital, Gentofte		Hellerup	Capital Region	2900	Denmark

Condition Browse Module

MeSH Terms

ID	Term
D003920	Diabetes Mellitus

Ancestor Terms

ID	Term
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases
D004700	Endocrine System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D012965	Sodium Chloride

Ancestor Terms

ID	Term
D002712	Chlorides
D006851	Hydrochloric Acid
D017606	Chlorine Compounds
D007287	Inorganic Chemicals

Browse Leaves

Not provided

Browse Branches

Not provided