GLP-1 Signaling in Truncally Vagotomized Subjects

NCT ID: NCT02940184

Last Updated: 2018-05-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-06-30

Study Completion Date

2018-10-31

Brief Summary

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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.

Detailed Description

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Conditions

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Physiology

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Tablet Sitagliptin 100mg (evening before and morning of experiments)

Intervention Type DRUG

On one of two experiment days participants will have Dipeptidyl peptidase 4 activity inhibited using a DPP-4 inhibitor (Sitagliptin).

Intestinal Fructose administration

Intervention Type OTHER

On both experimental days fructose (35g dissolved in water, total volume 100mL) will be administered via an intrajejunal tube

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.

Group Type EXPERIMENTAL

Intestinal Fructose administration

Intervention Type OTHER

On both experimental days fructose (35g dissolved in water, total volume 100mL) will be administered via an intrajejunal tube

Interventions

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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).

Intervention Type DRUG

Intestinal Fructose administration

On both experimental days fructose (35g dissolved in water, total volume 100mL) will be administered via an intrajejunal tube

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

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


* Normal fasting plasma glucose
* Normal haemoglobin concentration
* 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:


* 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
Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Rigshospitalet, Denmark

OTHER

Sponsor Role collaborator

University of Copenhagen

OTHER

Sponsor Role lead

Responsible Party

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Simon Veedfald

MD, PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Department of Surgery C, Rigshospitalet

Copenhagen, , Denmark

Site Status RECRUITING

Countries

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Denmark

Facility Contacts

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Simon Veedfald, MD

Role: primary

+45 41 10 25 95

Lars Bo Svendsen, Dr.Med.Sci

Role: backup

+45 35 45 21 22

Other Identifiers

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UC/RH-vago-GLP-1

Identifier Type: -

Identifier Source: org_study_id

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