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Intact Vagal Innervation and Glucagon-like Peptide-1 (GLP-1) Effects
Recruitment status was: Active, not recruiting
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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 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 | Intervention |
|---|---|
| Vagotomy, Truncal | Drug: GLP-1 Other: Saline |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Intervention Model: Parallel Assignment Masking: 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 |
- 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 ]
| Estimated Enrollment: | 30 |
| Study Start Date: | July 2008 |
| Estimated Study Completion Date: | December 2012 |
| Primary Completion Date: | August 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Vago
Truncally vagotomized subjects (due to duodenal ulcer operation)
|
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
|
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
|
Detailed Description:
Eligibility| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| 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
Contacts and LocationsPlease refer to this study by its ClinicalTrials.gov identifier: 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 |
More Information
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Jonatan I Bagger, MD, University Hospital, Gentofte, Copenhagen |
| ClinicalTrials.gov Identifier: | NCT01176890 History of Changes |
| Other Study ID Numbers: |
Truncated mealtest (AP) |
| Study First Received: | August 5, 2010 |
| Last Updated: | December 6, 2012 |
Keywords provided by Jonatan I Bagger, University Hospital, Gentofte, Copenhagen:
|
truncal vagotomy GLP-1 gastric emptying appetite food intake |
Additional relevant MeSH terms:
|
Glucagon-Like Peptide 1 Glucagon Incretins Hormones |
Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Gastrointestinal Agents |
ClinicalTrials.gov processed this record on July 21, 2017