PhysiologyNCT02940184
GLP-1 Signaling in Truncally Vagotomized Subjects
A study testing Tablet Sitagliptin 100mg (evening before and morning of experiments) and Intestinal Fructose administration in people with Physiology, run by University of Copenhagen at 1 site in Denmark.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- Physiology
- What is being tested?
- Tablet Sitagliptin 100mg (evening before and morning of experiments) and Intestinal Fructose administration
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteDenmark
- Study dates
- Jun 2016to Oct 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Normal fasting plasma glucose
- Normal haemoglobin concentration
- Cardiaresection with a pyloroplasty
- Informed consent
- Normal fasting plasma glucose
- Normal haemoglobin concentration
- Informed consent
Who cannot join
- 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
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- 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:
- 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 locations and contacts
1 site in 1 country.
Denmark1 site, 1 recruiting
- Recruiting
Department of Surgery C, Rigshospitalet
Copenhagen, 2100
Simon Veedfald, MD, +45 41 10 25 95
Lars Bo Svendsen, Dr.Med.Sci, +45 35 45 21 22, Lars.Bo.Svendsen@regionh.dk
About this study
Official title: Vagal Mechanisms Mediating the Effects of Glucagon-Like Peptide 1 (GLP-1) on the Endocrine Pancreas - the Entero-endocrine Axis.
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.
- Conditions
- Physiology
- Being tested
- Tablet Sitagliptin 100mg (evening before and morning of experiments), Intestinal Fructose administration
- Keywords
- Physiology
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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).
Intestinal Fructose administrationOther
On both experimental days fructose (35g dissolved in water, total volume 100mL) will be administered via an intrajejunal tube
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Intestinal Fructose administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Insulin secretion
Evaluated by c-peptide and insulin levels - Plasma collected up to 4 hours will be analyzed for peptide hormones
Measured: up to 4 hours
Secondary outcomes (4)
Glucagon secretion
Plasma collected over 4 hours will be analyzed for peptide hormones
Measured: 4 hours
Glucose levels
Plasma collected over 4 hours will be analyzed for glucose
Measured: 4 hours
Pancreatic Polypeptide levels
Plasma collected over 4 hours will be analyzed for peptide hormones
Measured: 4 hours
GIP secretion
Plasma collected over 4 hours will be analyzed for peptide hormones
Measured: 4 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2016 (estimated)
- Study startJun 2016
- Primary completionOct 2018 (estimated)
- Study completionOct 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PhysiologyStudies of the same condition, open and under way.
- More trials run by University of CopenhagenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Copenhagen
- Sponsor type
- University, hospital or other
- Collaborators
- Copenhagen University Hospital, Rigshospitalet
- Responsible party
- Principal investigator, Simon Veedfald, Copenhagen University Hospital, Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02940184
- Sponsor's protocol ID
- UC/RH-vago-GLP-1
- Status last verified
- May 2018
- First submitted
- 7 Apr 2016
- Last updated
- 22 May 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vagal Mechanisms Mediating the Effects of Glucagon-Like Peptide 1 (GLP-1) on the Endocrine Pancreas - the Entero-endocrine Axis.
- ClinicalTrials.gov ID
- NCT02940184
- Acronym / sponsor ID
- UC/RH-vago-GLP-1
- Conditions
- Physiology
- Keywords
- Physiology
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- University of CopenhagenUniversity, hospital or other
- Collaborators
- Copenhagen University Hospital, Rigshospitalet
- Study start
- Jun 2016
- Primary completion
- Oct 2018 (estimated)
- Study completion
- Oct 2018 (estimated)
- First posted
- 20 Oct 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Enteral fructose with DPP-4 inhibition | Experimental | Drug: Tablet Sitagliptin 100mg (evening before and morning of experiments), Other: Intestinal Fructose administrationEnteral 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 | Experimental | Other: Intestinal Fructose administrationEnteral 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Normal fasting plasma glucose
- Normal haemoglobin concentration
- Cardiaresection with a pyloroplasty
- Informed consent
- Normal fasting plasma glucose
Key exclusion criteria (42 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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). | Drug | Enteral fructose with DPP-4 inhibition |
| Intestinal Fructose administrationOn both experimental days fructose (35g dissolved in water, total volume 100mL) will be administered via an intrajejunal tube | Other | Enteral fructose with DPP-4 inhibition, Enteral fructose without DPP-4 inhibition |
Primary outcome
Insulin secretion
Time frame: up to 4 hours
Evaluated by c-peptide and insulin levels - Plasma collected up to 4 hours will be analyzed for peptide hormones
4 secondary outcomes
Glucagon secretion
Time frame: 4 hours
Glucose levels
Time frame: 4 hours
Pancreatic Polypeptide levels
Time frame: 4 hours
GIP secretion
Time frame: 4 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tablet Sitagliptin 100mg (evening before and morning of experiments) and Intestinal Fructose administration in people with Physiology, run by University of Copenhagen at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 42 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Insulin secretion (time frame: up to 4 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2018.