Intact Vagal Innervation for and Glucagon-like Peptide-1 (GLP-1) Effects
This study is ongoing, but not recruiting participants.
Sponsor:
University Hospital, Gentofte, Copenhagen
Collaborator:
University of Copenhagen
Information provided by (Responsible Party):
Jonatan I Bagger, University Hospital, Gentofte, Copenhagen
ClinicalTrials.gov Identifier:
NCT01176760
First received: August 5, 2010
Last updated: December 6, 2012
Last verified: December 2012
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Vagotomy, Truncal |
Drug: Dipeptidyl peptidase 4 (DPP 4) inhibitor Other: oral glucose |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Pharmacodynamics Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Basic Science |
| Official Title: | The Significances of Intact Vagal Innervation for the Glucose and GLP1 Induced Insulin Secretion |
Resource links provided by NLM:
Further study details as provided by University Hospital, Gentofte, Copenhagen:
Primary Outcome Measures:
- insulin secretion [ Time Frame: four hours ] [ Designated as safety issue: No ]The insulin secretion during a four-hour oral glucose tolerance test (OGTT) and an intravenous isoglycaemic clamp is evaluated
Secondary Outcome Measures:
- plasma GLP-1 [ Time Frame: 12 time points within four hours ] [ Designated as safety issue: No ]12 blood samples will be drawn during the four hours OGTT and intravenous isoglycaemic clamp, most frequently during the first hour
- plasma GIP [ Time Frame: 12 time points within four hours ] [ Designated as safety issue: No ]12 blood samples will be drawn during the four hours OGTT and intravenous isoglycaemic clamp, most frequently during the first hour
- plasma glucagon [ Time Frame: 12 time points within four hours ] [ Designated as safety issue: No ]12 blood samples will be drawn during the four hours OGTT and intravenous isoglycaemic clamp, most frequently during the first hour
- plasma GLP-2 [ Time Frame: 12 time points within four hours ] [ Designated as safety issue: No ]12 blood samples will be drawn during the four hours OGTT and intravenous isoglycaemic clamp, most frequently during the first hour
- plasma PYY [ Time Frame: 12 time points within four hours ] [ Designated as safety issue: No ]12 blood samples will be drawn during the four hours OGTT and intravenous isoglycaemic clamp, most frequently during the first hour
| Estimated Enrollment: | 30 |
| Study Start Date: | August 2009 |
| Estimated Study Completion Date: | December 2012 |
| Primary Completion Date: | October 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Vago
Truncally vagotomized subjects (due to duodenal ulcer operation)
|
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 Name: Galvus
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.
Other Name: panodil
|
|
Experimental: Cardia
Truncally vagotomized subjects (due to cardia resection)
|
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 Name: Galvus
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.
Other Name: panodil
|
|
Experimental: Ctrl
Healthy matched control subjects
|
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 Name: Galvus
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.
Other Name: panodil
|
Detailed 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
Eligibility| Ages Eligible for Study: | 18 Years to 90 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Criteria
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01176760
Locations
| Denmark | |
| Department of internal medicine F´laboratory, Gentofte Hospital | |
| Hellerup, Copenhagen, Denmark, 2900 | |
Sponsors and Collaborators
University Hospital, Gentofte, Copenhagen
University of Copenhagen
Investigators
| Principal Investigator: | Astrid Plamboeck, MD | University Hospital, Gentofte, Copenhagen |
| Study Director: | Tina Vilsbøll, MD, dr.med | University Hospital, Gentofte, Copenhagen |
More Information
No publications provided
| Responsible Party: | Jonatan I Bagger, MD, University Hospital, Gentofte, Copenhagen |
| ClinicalTrials.gov Identifier: | NCT01176760 History of Changes |
| Other Study ID Numbers: | Truncated isoglycemia |
| Study First Received: | August 5, 2010 |
| Last Updated: | December 6, 2012 |
| Health Authority: | Denmark: Danish Dataprotection Agency |
Keywords provided by University Hospital, Gentofte, Copenhagen:
|
vagotomy vagus GLP-1 Insulin secretion |
Additional relevant MeSH terms:
|
Glucagon-Like Peptide 1 Glucagon Dipeptidyl-Peptidase IV Inhibitors Incretins Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs |
Pharmacologic Actions Gastrointestinal Agents Therapeutic Uses Protease Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Hypoglycemic Agents |
ClinicalTrials.gov processed this record on May 21, 2013