HealthyNIHINCT04179331
Neurotensin Infusions in Healthy Individuals -
A study testing Neurotensin and Saline in people with Healthy, run by University of Copenhagen at 1 site in Denmark.
Trial summary
Neurotensin (NT) is a gut peptide released postprandially from the small intestine. It is known to exert a range of enterogastrone effects and in animal models it reduces food intake when administered by parenteral routes. Read more about this study
- Who is it for?
- Ages 18 to 50 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Neurotensin and Saline
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Mar 2019to 23 Jan 2020
- 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 to 50 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age = or above 18 years
- normal haemoglobin levels
- male
- Informed consent
Who cannot join
- Diabetes mellitus (fasting plasma glucose or HbA1c)
- Familiy history of diabetes mellitus
- Intestinal disease (incl e.g. inflammatory bowel disease and malabsorbtion)
- Family history of inflammatory bowel disease
- Previous intestinal resection
- Body mass index (BMI) over 25 kg/m2
Show all 9Show fewer
- Smoker
- Nephropathy (S-creatinine> 130 μM)
- Liver disease (ALAT and/or ASAT > 2 × upper normal limit)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Neurotensin Infusions in Healthy Individuals - Effects on Appetite, Food Intake, Hormone Secretions and Cardiovascular Responses
Neurotensin (NT) is a gut peptide released postprandially from the small intestine. It is known to exert a range of enterogastrone effects and in animal models it reduces food intake when administered by parenteral routes.
In this study, after a 1h baseline period, three doses (2.5, 5.0 and 7.5pmol/kg/min) of NT will be administered in sequence each infusion lasting 1h. On a placebo day saline will be infused similarly 1h infusions. During the final infusion (7.5pmol/kg/min) an ad libitum meal will be ingested. During the experiments blood samples will be collected and subjective perceptions recorded using validated visual analogue scales.
- Conditions
- Healthy
- Being tested
- Neurotensin, Saline
- Keywords
- Appetite regulation, Food intake, Ad libitum, Hormone secretion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NeurotensinOther
Neurotensin is an endogenous peptide released from the distal small intestine. It will be administered at three doses (2.5, 5.0 and 7.5pmol/kg/min), each for 1h, in sequence.
SalineOther
Isotonic saline will serve as a placebo.
| Study group | Role | What they receive |
|---|---|---|
| Neurotensin | Experimental | Not described Receives: Other: Neurotensin |
| Saline | Experimental | Not described Receives: Other: Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Food intake
The amount of food ingested over 30 minutes will be determined.
Measured: From time point t=190-220 minutes
Secondary outcomes (12)
Hunger
Visual analogue scale (100mm)
Measured: -45, -15, 15, 45, 75, 105, 135, 165, 220, 250 minutes
Satiation
Visual analogue scale (100mm)
Measured: -45, -15, 15, 45, 75, 105, 135, 165, 220, 250 minutes
Fullness
Visual analogue scale (100mm)
Measured: -45, -15, 15, 45, 75, 105, 135, 165, 220, 250 minutes
Prospective food intake
Visual analogue scale (100mm)
Measured: -45, -15, 15, 45, 75, 105, 135, 165, 220, 250 minutes
Comfort
Visual analogue scale (100mm)
Measured: -45, -15, 15, 45, 75, 105, 135, 165, 220, 250 minutes
Thirst
Visual analogue scale (100mm)
Measured: -45, -15, 15, 45, 75, 105, 135, 165, 220, 250 minutes
Neurotensin
plasma concentration (intact and total)
Measured: -60, -30, -15, 0, 15, 30, 60, 75, 90, 120, 135, 150, 180, 220 minutes
Pancreatic polypeptide
Plasma concentration (intact and total)
Measured: -60, -30, -15, 0, 15, 30, 60, 75, 90, 120, 135, 150, 180, 220 minutes
Glucagon
Plasma concentration
Measured: -60, -30, -15, 0, 15, 30, 60, 75, 90, 120, 135, 150, 180, 220 minutes
insulin and C-peptide
Serum concentration
Measured: -60, -30, -15, 0, 15, 30, 60, 75, 90, 120, 135, 150, 180, 220 minutes
Heart rate
Pulse rate every 10 min
Measured: -60 to 250 minutes
Blood pressure
Systolic and diastolic blood pressures (mmHg) every 10 minutes
Measured: -60 to 250 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2019
- Study start1 Mar 2019
- Primary completion23 Jan 2020
- Study completion23 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- Model description
- Acute physiological experiments conducted in healthy individuals in a University Hospital setting.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Copenhagen
- Sponsor type
- University, hospital or other
- Collaborators
- Hvidovre University Hospital
- Responsible party
- Principal investigator, Simon Veedfald, University of Copenhagen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04179331
- Sponsor's protocol ID
- NT-2-19
- Acronym
- NIHI
- Status last verified
- Jun 2021
- First submitted
- 7 Nov 2019
- Last updated
- 7 Jun 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neurotensin Infusions in Healthy Individuals - Effects on Appetite, Food Intake, Hormone Secretions and Cardiovascular Responses
- ClinicalTrials.gov ID
- NCT04179331
- Acronym / sponsor ID
- NIHI / NT-2-19
- Conditions
- Healthy
- Keywords
- Appetite regulation, Food intake, Ad libitum, Hormone secretion
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- University of CopenhagenUniversity, hospital or other
- Collaborators
- Hvidovre University Hospital
- Study start
- 1 Mar 2019 (actual)
- Primary completion
- 23 Jan 2020 (actual)
- Study completion
- 23 Jan 2020 (actual)
- First posted
- 27 Nov 2019 (actual)
- 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.
Neurotensin (NT) is a gut peptide released postprandially from the small intestine. It is known to exert a range of enterogastrone effects and in animal models it reduces food intake when administered by parenteral routes.
In this study, after a 1h baseline period, three doses (2.5, 5.0 and 7.5pmol/kg/min) of NT will be administered in sequence each infusion lasting 1h. On a placebo day saline will be infused similarly 1h infusions. During the final infusion (7.5pmol/kg/min) an ad libitum meal will be ingested. During the experiments blood samples will be collected and subjective perceptions recorded using validated visual analogue scales.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Acute physiological experiments conducted in healthy individuals in a University Hospital setting.
| Arm | Type | Receives |
|---|---|---|
| Neurotensin | Experimental | Other: Neurotensin |
| Saline | Experimental | Other: Saline |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Age = or above 18 years
- normal haemoglobin levels
- male
- Informed consent
Key exclusion criteria (9 listed)
- Diabetes mellitus (fasting plasma glucose or HbA1c)
- Familiy history of diabetes mellitus
- Intestinal disease (incl e.g. inflammatory bowel disease and malabsorbtion)
- Family history of inflammatory bowel disease
- Previous intestinal resection
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 |
|---|---|---|
| NeurotensinNeurotensin is an endogenous peptide released from the distal small intestine. It will be administered at three doses (2.5, 5.0 and 7.5pmol/kg/min), each for 1h, in sequence. | Other | Neurotensin |
| SalineIsotonic saline will serve as a placebo. | Other | Saline |
Primary outcome
Food intake
Time frame: From time point t=190-220 minutes
The amount of food ingested over 30 minutes will be determined.
12 secondary outcomes
Hunger
Time frame: -45, -15, 15, 45, 75, 105, 135, 165, 220, 250 minutes
Satiation
Time frame: -45, -15, 15, 45, 75, 105, 135, 165, 220, 250 minutes
Fullness
Time frame: -45, -15, 15, 45, 75, 105, 135, 165, 220, 250 minutes
Prospective food intake
Time frame: -45, -15, 15, 45, 75, 105, 135, 165, 220, 250 minutes
Comfort
Time frame: -45, -15, 15, 45, 75, 105, 135, 165, 220, 250 minutes
Thirst
Time frame: -45, -15, 15, 45, 75, 105, 135, 165, 220, 250 minutes
Neurotensin
Time frame: -60, -30, -15, 0, 15, 30, 60, 75, 90, 120, 135, 150, 180, 220 minutes
Pancreatic polypeptide
Time frame: -60, -30, -15, 0, 15, 30, 60, 75, 90, 120, 135, 150, 180, 220 minutes
Glucagon
Time frame: -60, -30, -15, 0, 15, 30, 60, 75, 90, 120, 135, 150, 180, 220 minutes
insulin and C-peptide
Time frame: -60, -30, -15, 0, 15, 30, 60, 75, 90, 120, 135, 150, 180, 220 minutes
Heart rate
Time frame: -60 to 250 minutes
Blood pressure
Time frame: -60 to 250 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jun 2021.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Neurotensin and Saline in people with Healthy, 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 4 inclusion and 9 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: finished, as of the sponsor's last update on 7 Jun 2021. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Food intake (time frame: From time point t=190-220 minutes). 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 7 Jun 2021.