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

NCT01176890 | Unknown

• 1 other identifier: Truncated mealtest (AP)
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Vagotomy, Truncal

Keywords

truncal vagotomy; GLP-1; gastric emptying; appetite; food intake

Outcome Measures

Primary Outcomes (3)

• Gastric emptying

  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

  four hours

• Appetite

  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)

  four hours

• Food intake

  After the liquid meal test, the volunteers will be offered a meal to assessed their ad libitum food intake

  five hours

Secondary Outcomes (7)

• plasma glucose

  four hours

• serum insulin and c-peptide

  four hours

• plasma glucagon

  four hours

• plasma GLP-1

  four hours

• endogenous GLP-1

  four hours

Study Arms (3)

Vago

EXPERIMENTAL

Truncally vagotomized subjects (due to duodenal ulcer operation)

Drug: GLP-1; Other: Saline

Cardia

EXPERIMENTAL

truncally vagotomized subjects (due to esophagus resection)

Drug: GLP-1; Other: Saline

Healthy controls

EXPERIMENTAL

Healthy control subjects

Drug: GLP-1; Other: Saline

Interventions

GLP-1 DRUG

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

Also known as: Panodil

Cardia; Healthy controls; Vago

Saline OTHER

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

Also known as: Panodil

Cardia; Healthy controls; Vago

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• truncal vagotomy
• normal hemoglobin
• informed consent
• Age, gender and weight matched controls
• normal hemoglobin
• informed consent

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Gentofte, Copenhagen: lead
• University of Copenhagen: collaborator

Study Sites (1)

Department of Internal Medicine F' laboratory

Hellerup, Copenhagen, 2900, Denmark

Location

Related Publications (2)

• Wewer Albrechtsen NJ, Hartmann B, Veedfald S, Windelov JA, Plamboeck A, Bojsen-Moller KN, Idorn T, Feldt-Rasmussen B, Knop FK, Vilsboll T, Madsbad S, Deacon CF, Holst JJ. Hyperglucagonaemia analysed by glucagon sandwich ELISA: nonspecific interference or truly elevated levels? Diabetologia. 2014 Sep;57(9):1919-26. doi: 10.1007/s00125-014-3283-z. Epub 2014 Jun 3.

  PMID: 24891019 DERIVED

• Plamboeck A, Veedfald S, Deacon CF, Hartmann B, Wettergren A, Svendsen LB, Meisner S, Hovendal C, Vilsboll T, Knop FK, Holst JJ. The effect of exogenous GLP-1 on food intake is lost in male truncally vagotomized subjects with pyloroplasty. Am J Physiol Gastrointest Liver Physiol. 2013 Jun 15;304(12):G1117-27. doi: 10.1152/ajpgi.00035.2013. Epub 2013 Apr 18.

  PMID: 23599045 DERIVED

MeSH Terms

Interventions

Glucagon-Like Peptide 1; Sodium Chloride

Intervention Hierarchy (Ancestors)

Glucagon-Like Peptides; Proglucagon; Gastrointestinal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Astrid Plamboeck, M.D.

  University Hospital, Gentofte, Copenhagen

  PRINCIPAL INVESTIGATOR

• Tina Vilsbøll, M.D.

  University Hospital, Gentofte, Copenhagen

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: August 5, 2010
• First Posted: August 6, 2010
• Study Start: July 1, 2008
• Primary Completion: August 1, 2011
• Study Completion: December 1, 2012
• Last Updated: December 7, 2012

Record last verified: 2012-12

Locations

DK (1)