Skip to content

GLP-1 Signaling in Truncally Vagotomized Subjects

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02940184
Enrollment
24
Registered
2016-10-20
Start date
2016-06-30
Completion date
2018-10-31
Last updated
2018-05-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Physiology

Keywords

Physiology

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.

Interventions

DRUGTablet 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).

OTHERIntestinal Fructose administration

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

Sponsors

Rigshospitalet, Denmark
CollaboratorOTHER
University of Copenhagen
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
NONE

Eligibility

Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion 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

Design outcomes

Primary

MeasureTime frameDescription
Insulin secretionup to 4 hoursEvaluated by c-peptide and insulin levels - Plasma collected up to 4 hours will be analyzed for peptide hormones

Secondary

MeasureTime frameDescription
Glucagon secretion4 hoursPlasma collected over 4 hours will be analyzed for peptide hormones
Glucose levels4 hoursPlasma collected over 4 hours will be analyzed for glucose
Pancreatic Polypeptide levels4 hoursPlasma collected over 4 hours will be analyzed for peptide hormones
GIP secretion4 hoursPlasma collected over 4 hours will be analyzed for peptide hormones

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026