GLP-1 Signaling in Truncally Vagotomized Subjects

University of Copenhagen

Status: Unknown

Conditions: Physiology

Treatments: Drug: Tablet Sitagliptin 100mg (evening before and morning of experiments); Other: Intestinal Fructose administration

Study type: Interventional

Funder types: Other

Identifiers

NCT02940184

UC/RH-vago-GLP-1

Details and patient eligibility

About

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.

Enrollment: 24 estimated patients

Sex: Male

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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24 participants in 2 patient groups

Enteral fructose with DPP-4 inhibition

Experimental group

Description:

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.

Treatment:

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

Other: Intestinal Fructose administration

Enteral fructose without DPP-4 inhibition

Experimental group

Description:

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.

Treatment:

Other: Intestinal Fructose administration