Intact Vagal Innervation and Glucagon-like Peptide-1 (GLP-1) Effects
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ClinicalTrials.gov Identifier: NCT01176890 |
Recruitment Status : Unknown
Verified December 2012 by Jonatan I Bagger, University Hospital, Gentofte, Copenhagen.
Recruitment status was: Active, not recruiting
First Posted : August 6, 2010
Last Update Posted : December 7, 2012
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The aim of this study is to investigate the role of transmission via the vagal nerve for the effect of Glucagon-like peptide-1 (GLP-1) in respect to gastric emptying, appetite and food intake.
The hypothesis is that a great deal of the effects of GLP-1 is mediated via the nervous system and for this reason the researchers will investigate individuals with and without intact nervous supply.
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Vagotomy, Truncal | Drug: GLP-1 Other: Saline | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 30 participants |
Allocation: | Non-Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Basic Science |
Official Title: | The Significance of Intact Vagal Innervation for the GLP-1 Induced Inhibition of Gastric Emptying, Appetite and Food Intake |
Study Start Date : | July 2008 |
Actual Primary Completion Date : | August 2011 |
Estimated Study Completion Date : | December 2012 |
Arm | Intervention/treatment |
---|---|
Experimental: Vago
Truncally vagotomized subjects (due to duodenal ulcer operation)
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Drug: GLP-1
1.2 pmol/kg/min GLP-1 will be infused intravenously during the four hour meal test (100 g Ny NAN1 and 1.5 g paracetamol dissolved in 300 ml water) ingested over 10 minutes. After four hours an ad libitum meal will be supplied Other Name: Panodil Other: Saline Saline (isotonic NaCl) will be infused intravenously during the four hour meal test (100 g Ny NAN1 and 1.5 g paracetamol dissolved in 300 ml water) ingested over 10 minutes. After four hours an ad libitum meal will be supplied Other Name: Panodil |
Experimental: Cardia
truncally vagotomized subjects (due to esophagus resection)
|
Drug: GLP-1
1.2 pmol/kg/min GLP-1 will be infused intravenously during the four hour meal test (100 g Ny NAN1 and 1.5 g paracetamol dissolved in 300 ml water) ingested over 10 minutes. After four hours an ad libitum meal will be supplied Other Name: Panodil Other: Saline Saline (isotonic NaCl) will be infused intravenously during the four hour meal test (100 g Ny NAN1 and 1.5 g paracetamol dissolved in 300 ml water) ingested over 10 minutes. After four hours an ad libitum meal will be supplied Other Name: Panodil |
Experimental: Healthy controls
Healthy control subjects
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Drug: GLP-1
1.2 pmol/kg/min GLP-1 will be infused intravenously during the four hour meal test (100 g Ny NAN1 and 1.5 g paracetamol dissolved in 300 ml water) ingested over 10 minutes. After four hours an ad libitum meal will be supplied Other Name: Panodil Other: Saline Saline (isotonic NaCl) will be infused intravenously during the four hour meal test (100 g Ny NAN1 and 1.5 g paracetamol dissolved in 300 ml water) ingested over 10 minutes. After four hours an ad libitum meal will be supplied Other Name: Panodil |
- Gastric emptying [ Time Frame: four hours ]Gastric emptying will be assessed using a liquid meal with 1.5 g paracetamol added and continuous blood sampling for measuring paracetamol concentration during four hours
- Appetite [ Time Frame: four hours ]Hunger, satiation, and fullness will be assessed before, during and after a liquid meal with 1.5 g paracetamol added using a visual analog scale (VAS)
- Food intake [ Time Frame: five hours ]After the liquid meal test, the volunteers will be offered a meal to assessed their ad libitum food intake
- plasma glucose [ Time Frame: four hours ]
- serum insulin and c-peptide [ Time Frame: four hours ]
- plasma glucagon [ Time Frame: four hours ]
- plasma GLP-1 [ Time Frame: four hours ]
- endogenous GLP-1 [ Time Frame: four hours ]endogenous GLP-1 will be assessed as plasma GLP-2 concentration
- plasma GIP [ Time Frame: four hours ]
- serum paracetamol [ Time Frame: four hours ]

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- truncal vagotomy
- normal hemoglobin
- informed consent
- Age, gender and weight matched controls
- normal hemoglobin
- informed consent
Exclusion Criteria:
- type 1 diabetes mellitus or type 2 diabetes mellitus
- body mass index > 30 kg/m2
- inflammatory bowel disease
- intestinal resection
- nephropathy (serum creatinine > 150 µM and/or albuminuria)
- liver disease (ALAT and/or ASAT > 2 x normal value)
- treatment with medicine which cannot be paused for 12 hours

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01176890
Denmark | |
Department of Internal Medicine F' laboratory | |
Hellerup, Copenhagen, Denmark, 2900 |
Principal Investigator: | Astrid Plamboeck, M.D. | University Hospital, Gentofte, Copenhagen | |
Study Director: | Tina Vilsbøll, M.D. | University Hospital, Gentofte, Copenhagen |
Responsible Party: | Jonatan I Bagger, MD, University Hospital, Gentofte, Copenhagen |
ClinicalTrials.gov Identifier: | NCT01176890 |
Other Study ID Numbers: |
Truncated mealtest (AP) |
First Posted: | August 6, 2010 Key Record Dates |
Last Update Posted: | December 7, 2012 |
Last Verified: | December 2012 |
truncal vagotomy GLP-1 gastric emptying appetite food intake |