Intact Vagal Innervation for and Glucagon-like Peptide-1 (GLP-1) Effects

Vagotomy, Truncal Clinical Trial

Official title:

The Significances of Intact Vagal Innervation for the Glucose and GLP1 Induced Insulin Secretion

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01176760
• Other study ID #: Truncated isoglycemia
• Status: Active, not recruiting
• Phase: N/A
• First received: August 5, 2010
• Last updated: December 6, 2012
• Start date: August 2009
• Est. completion date: December 2012

Study information

• Verified date: December 2012
• Source: University Hospital, Gentofte, Copenhagen
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Dataprotection Agency
• Study type: Interventional

Clinical Trial Summary

The aim of this study is to investigate the role of transmission via the vagal nerve for the effect of glucose and Glucagon-like peptide-1 (GLP-1) in respect to insulin secretion.

The hypothesis is that a great deal of the effects of GLP-1 is mediated via the nervous system and for this reason the investigators will research individuals with and without intact nervous supply.

Description:

GLP-1 is a potent enterogastron and incretin hormone. It is rapidly inactivated by dipeptidyl peptidase IV so only 10-15% enters the systemic circulation. This has led to the hypothesis that GLP-1 interact locally with afferent sensory nerve fibers. We investigated the role of intact vagal innervations on the effect of glucose and GLP-1 on the insulin secretion

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 30
• Est. completion date: December 2012
• Est. primary completion date: October 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

Inclusion Criteria:

• normal fasting plasma glucose

• normal hemoglobin

• informed consent

Exclusion Criteria:

• type 1 diabetes mellitus or type 2 diabetes mellitus

• body mass index > 30

• inflammatory bowel disease

• intestinal surgery

• serum creatinine > 250 µM and/or albuminuria

• ALAT > 2 x normal value

• Severe cardiac insufficiency

• in treatment with medicine which cannot be paused for 12 hours

Study Design

Allocation: Non-Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Vagotomy, Truncal

Intervention

Drug:
• Dipeptidyl peptidase 4 (DPP 4) inhibitor
One tablet (50 mg)of DPP4 inhibitor is to be taken 12 and 1 hours before start of the oral glucose tolerance test (50 g glucose and 1.5 g paracetamol dissolved in 300 ml water)on day 3

Other:
• oral glucose
50 g glucose dissolved in 300 ml water with 1,5 g paracetamol is to be ingested orally within the first 15 minutes.

Locations

Country	Name	City	State
Denmark	Department of internal medicine F´laboratory, Gentofte Hospital	Hellerup	Copenhagen

Sponsors (2)

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

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	insulin secretion	The insulin secretion during a four-hour oral glucose tolerance test (OGTT) and an intravenous isoglycaemic clamp is evaluated	four hours	No
Secondary	plasma GLP-1	12 blood samples will be drawn during the four hours OGTT and intravenous isoglycaemic clamp, most frequently during the first hour	12 time points within four hours	No
Secondary	plasma GIP	12 blood samples will be drawn during the four hours OGTT and intravenous isoglycaemic clamp, most frequently during the first hour	12 time points within four hours	No
Secondary	plasma glucagon	12 blood samples will be drawn during the four hours OGTT and intravenous isoglycaemic clamp, most frequently during the first hour	12 time points within four hours	No
Secondary	plasma GLP-2	12 blood samples will be drawn during the four hours OGTT and intravenous isoglycaemic clamp, most frequently during the first hour	12 time points within four hours	No
Secondary	plasma PYY	12 blood samples will be drawn during the four hours OGTT and intravenous isoglycaemic clamp, most frequently during the first hour	12 time points within four hours	No