Glucagon-Like Peptide-1 (GLP-1) Suppression of Alpha Cell Secretion in Type 2 Diabetes Mellitus (T2DM)
GLP-1 Suppression of Alpha Cell Secretion in T2DM
1 other identifier
interventional
20
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Oct 2006
Shorter than P25 for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2007
CompletedFirst Submitted
Initial submission to the registry
March 13, 2009
CompletedFirst Posted
Study publicly available on registry
March 17, 2009
CompletedMarch 18, 2009
March 1, 2009
5 months
March 13, 2009
March 17, 2009
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
glucagon suppression
Interventions
physiological effect of GLP-1
Eligibility Criteria
You may qualify if:
- T2DM according to WHO criteria
- Written consent
- Age \> 18 years
You may not qualify if:
- Kidney or hepatic disease
- Treatment with insulin or glitazone
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (1)
Hare KJ, Knop FK, Asmar M, Madsbad S, Deacon CF, Holst JJ, Vilsboll 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. doi: 10.1210/jc.2009-0921. Epub 2009 Oct 16.
PMID: 19837930DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
March 13, 2009
First Posted
March 17, 2009
Study Start
October 1, 2006
Primary Completion
March 1, 2007
Study Completion
March 1, 2007
Last Updated
March 18, 2009
Record last verified: 2009-03