GLP-1 Signaling in Truncally Vagotomized Subjects
Not Applicable
- Conditions
- Physiology
- Interventions
- Drug: Tablet Sitagliptin 100mg (evening before and morning of experiments)Other: Intestinal Fructose administration
- Registration Number
- NCT02940184
- Lead Sponsor
- University of Copenhagen
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- Male
- Target Recruitment
- 24
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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Enteral fructose with DPP-4 inhibition Tablet Sitagliptin 100mg (evening before and morning of experiments) 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. Enteral fructose with DPP-4 inhibition Intestinal Fructose administration 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. Enteral fructose without DPP-4 inhibition Intestinal Fructose administration 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.
- Primary Outcome Measures
Name Time Method Insulin secretion up to 4 hours Evaluated by c-peptide and insulin levels - Plasma collected up to 4 hours will be analyzed for peptide hormones
- Secondary Outcome Measures
Name Time Method Pancreatic Polypeptide levels 4 hours Plasma collected over 4 hours will be analyzed for peptide hormones
Glucagon secretion 4 hours Plasma collected over 4 hours will be analyzed for peptide hormones
GIP secretion 4 hours Plasma collected over 4 hours will be analyzed for peptide hormones
Glucose levels 4 hours Plasma collected over 4 hours will be analyzed for glucose
Trial Locations
- Locations (1)
Department of Surgery C, Rigshospitalet
🇩🇰Copenhagen, Denmark