Glucagon-Like Peptide-1 (GLP-1) Suppression of Alpha Cell Secretion in Type 2 Diabetes Mellitus (T2DM)

This study has been completed.

Sponsor:

Collaborator:

University of Copenhagen

Information provided by:

University Hospital, Gentofte, Copenhagen

ClinicalTrials.gov Identifier:

NCT00862589

First received: March 13, 2009

Last updated: March 17, 2009

Last verified: March 2009

History of Changes

Tracking Information
First Received Date ^ICMJE	March 13, 2009
Last Updated Date	March 17, 2009
Start Date ^ICMJE	October 2006
Primary Completion Date	March 2007 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: March 16, 2009)	glucagon suppression
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT00862589 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	Glucagon-Like Peptide-1 (GLP-1) Suppression of Alpha Cell Secretion in Type 2 Diabetes Mellitus (T2DM)
Official Title ^ICMJE	GLP-1 Suppression of Alpha Cell Secretion in T2DM
Brief Summary	The incretin hormone glucagon-like peptide-1 (GLP-1) has known insulinotrophic and glucagonostatic properties. However, inpatients with type 2 diabetes mellitus (T2DM)it is shown, that the beta cell sensitivity towards GLP-1 is decreased, when comparing to healthy controls. Further, these patients have decreased GLP-1 response to a meal. The aim of this study is to elucidate if the diabetic hyperglucagonemia, seen in these patients both during fasting and in a postprandial condition, is coursed by a decreased sensitivity to GLP-1 in the diabetic alpha cell. Ten T2DM patients and ten matched healthy control subjects will be examined on two separate days. Day 1: increasing GLP-1 infusions and Day 2: saline. During both days plasma glucose (PG) will be clamped at fasting level (FPG). Patients with T2DM will be submitted til a Day 3, here PG will be normalized over-night by an adjustable insulin infusion, on the following day the GLP-1 infusion of Day 1 will be repeated. The hypothesis is that these patients have decreased alpha cell sensitivity to GLP-1 as is the case with the beta cell sensitivity. This decreased sensitivity, the investigators speculate, contributes the defect suppression og glucagon and thereby to the increased PG levels seen in T2DM. Further the investigators will elucidate if this sensitivity can be increased by normalizing the diabetic PG to a normal FPG level.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Not Provided
Study Design ^ICMJE	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Single Blind (Subject)
Condition ^ICMJE	Hyperglycemia Hyperglucagonemia Glucose Intolerance
Intervention ^ICMJE	Other: GLP-1 infusion physiological effect of GLP-1
Study Arm (s)	Not Provided
Publications *	Hare KJ, Knop FK, Asmar M, Madsbad S, Deacon CF, Holst JJ, Vilsbøll T. Preserved inhibitory potency of GLP-1 on glucagon secretion in type 2 diabetes mellitus. J Clin Endocrinol Metab. 2009 Dec;94(12):4679-87. Epub 2009 Oct 16.
* 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	20
Completion Date	March 2007
Primary Completion Date	March 2007 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Inclusion Criteria: T2DM according to WHO criteria Written consent Age > 18 years Exclusion Criteria: Kidney or hepatic disease Treatment with insulin or glitazone
Gender	Both
Ages	18 Years to 70 Years
Accepts Healthy Volunteers	Yes
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Not Provided

Administrative Information
NCT Number ^ICMJE	NCT00862589
Other Study ID Numbers ^ICMJE	H-KA-20070023
Has Data Monitoring Committee	No
Responsible Party	Kristine Hare/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	March 2009
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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