Neurotensin Infusions in Healthy Individuals -

NCT ID: NCT04179331

Last Updated: 2021-06-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

9 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-03-01

Study Completion Date

2020-01-23

Brief Summary

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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.

Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Acute physiological experiments conducted in healthy individuals in a University Hospital setting.
Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors
Double blinded. Neither the investigators performing the experiments or the participants know the nature of the intervention on the two study days.

Study Groups

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Neurotensin

Group Type EXPERIMENTAL

Neurotensin

Intervention Type OTHER

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.

Saline

Group Type EXPERIMENTAL

Saline

Intervention Type OTHER

Isotonic saline will serve as a placebo.

Interventions

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Neurotensin

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.

Intervention Type OTHER

Saline

Isotonic saline will serve as a placebo.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Age = or above 18 years
* normal haemoglobin levels
* male
* Informed consent

Exclusion Criteria

* 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
* Smoker
* Nephropathy (S-creatinine\> 130 μM)
* Liver disease (ALAT and/or ASAT \> 2 × upper normal limit)
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Hvidovre University Hospital

OTHER

Sponsor Role collaborator

University of Copenhagen

OTHER

Sponsor Role lead

Responsible Party

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Simon Veedfald

Primary investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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hvidovre Hospital

Hvidovre, Capital, Denmark

Site Status

Countries

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Denmark

Other Identifiers

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NT-2-19

Identifier Type: -

Identifier Source: org_study_id

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