GLP-1 Signaling in Truncally Vagotomized Subjects

May 20, 2018 updated by: Simon Veedfald, University of Copenhagen

Vagal Mechanisms Mediating the Effects of Glucagon-Like Peptide 1 (GLP-1) on the Endocrine Pancreas - the Entero-endocrine Axis.

Investigation of the importance of vagal signaling for the glucohomeostatic effects of GLP-1. The study will include physiological studies of truncally vagotomized participants and matched controls.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

24

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Copenhagen, Denmark, 2100
        • Recruiting
        • Department of Surgery C, Rigshospitalet
        • Principal Investigator:
          • Simon Veedfald, MD
        • Contact:
          • Simon Veedfald, MD
          • Phone Number: +45 41 10 25 95
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

Truncally vagotomized individuals:

Inclusion Criteria:

  • Normal fasting plasma glucose
  • Normal haemoglobin concentration
  • Cardiaresection with a pyloroplasty
  • Informed consent

Exclusion Criteria:

  • Diabetes mellitus
  • Disposition for diabetes mellitus
  • Intestinal disease (apart from cardia resection+pyloroplasty)
  • Disposition of inflammatory bowel disease
  • Intestinal resection (apart from cardia resection+pyloroplasty)
  • Body mass index (BMI) > 27,5 kg/m2
  • Tobacco use
  • Nephropathy (se-creatinine> 130 µM and/or albuminuria)
  • Liver disease (ALAT and/or ASAT >2 × refference value)
  • known heart condition
  • medicinal use, that may not be paused for 12 hours
  • Obstipation
  • swallowing difficulties
  • previous problems with intestinal tube placement
  • Latex allergy
  • Fructose malabsorption
  • Known diseases in the pharynx
  • Previous facial or cranial fractures
  • Sinusitis
  • Bleeding diathesis

Matched controls:

Inclusion Criteria:

  • Normal fasting plasma glucose
  • Normal haemoglobin concentration
  • Informed consent

Exclusion Criteria:

  • Cardiaresection with a pyloroplasty
  • Diabetes mellitus
  • Disposition for diabetes mellitus
  • Intestinal disease (apart from cardia resection+pyloroplasty)
  • Disposition of inflammatory bowel disease
  • Intestinal resection tarmresektion (apart from cardia resection+pyloroplasty)
  • Body mass index (BMI) > 27,5 kg/m2
  • Tobacco use
  • Nephropathy (se-creatinine> 130 µM and/or albuminuria)
  • Liver disease (ALAT and/or ASAT >2 × refference value)
  • known heart condition
  • medicinal use, that may not be paused for 12 hours
  • Obstipation
  • swallowing difficulties
  • previous problems with intestinal tube placement
  • Latex allergy
  • Fructose malabsorption
  • Known diseases in the pharynx
  • Previous facial or cranial fractures
  • Sinusitis
  • Bleeding diathesis

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Enteral fructose with DPP-4 inhibition

Enteral fructose + DPP-4 inhibition (sitagliptin)

After DPP4 inhibition using Tablet Sitagliptin 100mg on the evening before and on the morning of experimentation enteral fructose is given via an intestinal tube (intrajejunal) to either truncally vagotomised and control individuals.
Drug: Tablet Sitagliptin 100mg (evening before and morning of experiments)
On one of two experiment days participants will have Dipeptidyl peptidase 4 activity inhibited using a DPP-4 inhibitor (Sitagliptin).
Other: Intestinal Fructose administration
On both experimental days fructose (35g dissolved in water, total volume 100mL) will be administered via an intrajejunal tube
Experimental: Enteral fructose without DPP-4 inhibition
Enteral fructose without DPP-4 inhibition (sitagliptin) After DPP4 inhibition using Tablet Sitagliptin 100mg on the evening before and on the morning of experimentation enteral fructose is given via an intestinal tube (intrajejunal) to either truncally vagotomised and control individuals.
Other: Intestinal Fructose administration
On both experimental days fructose (35g dissolved in water, total volume 100mL) will be administered via an intrajejunal tube

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Insulin secretion
Time Frame: up to 4 hours
Evaluated by c-peptide and insulin levels - Plasma collected up to 4 hours will be analyzed for peptide hormones
up to 4 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Glucagon secretion
Time Frame: 4 hours
Plasma collected over 4 hours will be analyzed for peptide hormones
4 hours
Glucose levels
Time Frame: 4 hours
Plasma collected over 4 hours will be analyzed for glucose
4 hours
Pancreatic Polypeptide levels
Time Frame: 4 hours
Plasma collected over 4 hours will be analyzed for peptide hormones
4 hours
GIP secretion
Time Frame: 4 hours
Plasma collected over 4 hours will be analyzed for peptide hormones
4 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Copenhagen

Collaborators

Rigshospitalet, Denmark

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2016

Primary Completion (Anticipated)

October 1, 2018

Study Completion (Anticipated)

October 1, 2018

Study Registration Dates

First Submitted

April 7, 2016

First Submitted That Met QC Criteria

October 19, 2016

First Posted (Estimate)

October 20, 2016

Study Record Updates

Last Update Posted (Actual)

May 22, 2018

Last Update Submitted That Met QC Criteria

May 20, 2018

Last Verified

May 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UC/RH-vago-GLP-1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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