NCT02940184

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2016

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 7, 2016

Completed
2 months until next milestone

Study Start

First participant enrolled

June 1, 2016

Completed
5 months until next milestone

First Posted

Study publicly available on registry

October 20, 2016

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2018

Completed
Last Updated

May 22, 2018

Status Verified

May 1, 2018

Enrollment Period

2.3 years

First QC Date

April 7, 2016

Last Update Submit

May 20, 2018

Conditions

Physiology

Keywords

Physiology

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • Glucagon secretion

    4 hours

  • Glucose levels

    4 hours

  • Pancreatic Polypeptide levels

    4 hours

  • GIP secretion

    4 hours

Study Arms (2)

Enteral fructose with DPP-4 inhibition

EXPERIMENTAL

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.

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

Enteral fructose without DPP-4 inhibition

EXPERIMENTAL

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.

Other: Intestinal Fructose administration

Interventions

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

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

Enteral fructose with DPP-4 inhibition
Intestinal Fructose administrationOTHER

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

Enteral fructose with DPP-4 inhibitionEnteral fructose without DPP-4 inhibition

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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
  • +30 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Surgery C, Rigshospitalet

Copenhagen, 2100, Denmark

RECRUITING

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD

Study Record Dates

First Submitted

April 7, 2016

First Posted

October 20, 2016

Study Start

June 1, 2016

Primary Completion

October 1, 2018

Study Completion

October 1, 2018

Last Updated

May 22, 2018

Record last verified: 2018-05

Locations

DK(1)