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

Hyperglycemia Clinical Trial

Official title:

GLP-1 Suppression of Alpha Cell Secretion in T2DM

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00862589
• Other study ID #: H-KA-20070023
• Status: Completed
• Phase: N/A
• First received: March 13, 2009
• Last updated: March 17, 2009
• Start date: October 2006
• Est. completion date: March 2007

Study information

• Verified date: March 2009
• Source: University Hospital, Gentofte, Copenhagen
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: March 2007
• Est. primary completion date: March 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• T2DM according to WHO criteria

• Written consent

• Age > 18 years

Exclusion Criteria:

• Kidney or hepatic disease

• Treatment with insulin or glitazone

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject)

Related Conditions & MeSH terms

• Glucose Intolerance
• Hyperglucagonemia
• Hyperglycemia

Intervention

Other:
• GLP-1 infusion
physiological effect of GLP-1

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Gentofte, Copenhagen	University of Copenhagen

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	glucagon suppression