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

This study has been completed.

Sponsor:

Collaborator:

University of Copenhagen

Information provided by:

University Hospital, Gentofte, Copenhagen

ClinicalTrials.gov Identifier:

NCT00732602

First received: August 11, 2008

Last updated: February 12, 2009

Last verified: February 2009

History of Changes

Tracking Information
First Received Date ^ICMJE	August 11, 2008
Last Updated Date	February 12, 2009
Start Date ^ICMJE	January 2008
Primary Completion Date	August 2008 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: August 11, 2008)	plasma-glucagon Area Under Curve at 0-90 min. and 90-180 min. [ Designated as safety issue: No ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT00732602 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE	Not Provided
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	The Effects of GIP and GLP-2 on the Secretion of Glucagon in Patients With Type 1 Diabetes
Official Title ^ICMJE	The Effects of GIP and GLP-2 on the Secretion of Glucagon in Patients With Type 1 Diabetes
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
Study Type ^ICMJE	Interventional
Study Phase	Not Provided
Study Design ^ICMJE	Allocation: Randomized Intervention Model: Crossover Assignment Masking: Single Blind (Subject) Primary Purpose: Basic Science
Condition ^ICMJE	Diabetes Mellitus
Intervention ^ICMJE	Other: GIP-infusion Other: Sodium-chloride Other: GLP-2 infusion
Study Arm (s)	Active Comparator: B GLP-2 infusion Intervention: Other: GLP-2 infusion Placebo Comparator: C Sodium-chloride infusion Intervention: Other: Sodium-chloride Active Comparator: A GIP-infusion Intervention: Other: GIP-infusion
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	8
Completion Date	Not Provided
Primary Completion Date	August 2008 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Denmark

Administrative Information
NCT Number ^ICMJE	NCT00732602
Other Study ID Numbers ^ICMJE	H-D-2007-0058
Has Data Monitoring Committee	No
Responsible Party	Mikkel Christensen MD, University Hospital, Gentofte, Copenhagen
Study Sponsor ^ICMJE	University Hospital, Gentofte, Copenhagen
Collaborators ^ICMJE	University of Copenhagen
Investigators ^ICMJE	Not Provided
Information Provided By	University Hospital, Gentofte, Copenhagen
Verification Date	February 2009
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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