GLP-1 Signaling in Truncally Vagotomized Subjects

Physiology Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02940184
• Other study ID #: UC/RH-vago-GLP-1
• Status: Recruiting
• Phase: N/A
• Start date: June 2016
• Est. completion date: October 2018

Study information

• Verified date: May 2018
• Source: University of Copenhagen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 24
• Est. completion date: October 2018
• Est. primary completion date: October 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Physiology

Intervention

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

Locations

Country	Name	City	State
Denmark	Department of Surgery C, Rigshospitalet	Copenhagen

Sponsors (2)

Lead Sponsor	Collaborator
University of Copenhagen	Rigshospitalet, Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Insulin secretion	Evaluated by c-peptide and insulin levels - Plasma collected up to 4 hours will be analyzed for peptide hormones	up to 4 hours
Secondary	Glucagon secretion	Plasma collected over 4 hours will be analyzed for peptide hormones	4 hours
Secondary	Glucose levels	Plasma collected over 4 hours will be analyzed for glucose	4 hours
Secondary	Pancreatic Polypeptide levels	Plasma collected over 4 hours will be analyzed for peptide hormones	4 hours
Secondary	GIP secretion	Plasma collected over 4 hours will be analyzed for peptide hormones	4 hours