Neurotensin - an Important Regulator of Appetite in Humans?

NCT ID: NCT03522792

Last Updated: 2019-11-12

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

UNKNOWN

Clinical Phase

NA

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-01-05

Study Completion Date

2019-12-01

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.

This study investigates whether the anorexic effects of NT suggested by animal studies can be translated.

Detailed Description

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Conditions

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Physiology - Regulation of Appetite and Food Intake

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Participants will be studied on multiple occasions (5 days) in a randomised and double blinded fashion. One day will serve as an acclimatization day.
Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors
Participants will not be informed of the nature of the infusion they are administered on any of the study days. The investigator will be provided with an infusion (either isotonic saline with HSA or isotonic salin with HSA + neurotensin) prepared by a designated colleague

Study Groups

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Saline + ad libitum meal

This will serve as the placebo / control day for the NT + ad libitum meal study day.

Group Type EXPERIMENTAL

Saline

Intervention Type OTHER

Intravenous infusion of saline

Ad libitum meal

Intervention Type OTHER

Participants will be served a large meal serving. They will be instructed to eat until they do not feel hungry anymore.

NT + ad libitum meal

Neurotensin (NT) infusion followed by an ad libitum meal to study the effect of NT on ad libitum food intake.

Group Type EXPERIMENTAL

Neurotensin

Intervention Type OTHER

Intravenous infusion of neurotensin

Ad libitum meal

Intervention Type OTHER

Participants will be served a large meal serving. They will be instructed to eat until they do not feel hungry anymore.

Saline + liquid meal + ad libitum meal

Saline infusion followed a standardized liquid mixed meal followed by an ad libitum meal. This will serve as the placebo / control day for the NT + standardized liquid mixed meal + ad libitum meal study day. Investigating the effect of NT on the second meal effect.

Group Type EXPERIMENTAL

Saline

Intervention Type OTHER

Intravenous infusion of saline

Ad libitum meal

Intervention Type OTHER

Participants will be served a large meal serving. They will be instructed to eat until they do not feel hungry anymore.

Liquid meal

Intervention Type OTHER

A standardized mixed liquid meal will be ingested to stimulate endogenous peptide hormone release

NT + liquid meal + ad libitum meal

NT infusion followed a standardized liquid mixed meal followed by an ad libitum meal. This study day aims to study the effect of NT on the second meal effect.

Group Type EXPERIMENTAL

Neurotensin

Intervention Type OTHER

Intravenous infusion of neurotensin

Ad libitum meal

Intervention Type OTHER

Participants will be served a large meal serving. They will be instructed to eat until they do not feel hungry anymore.

Liquid meal

Intervention Type OTHER

A standardized mixed liquid meal will be ingested to stimulate endogenous peptide hormone release

Neurotensin

Acclimatization day

Group Type EXPERIMENTAL

Neurotensin

Intervention Type OTHER

Intravenous infusion of neurotensin

Ad libitum meal

Intervention Type OTHER

Participants will be served a large meal serving. They will be instructed to eat until they do not feel hungry anymore.

Interventions

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Neurotensin

Intravenous infusion of neurotensin

Intervention Type OTHER

Saline

Intravenous infusion of saline

Intervention Type OTHER

Ad libitum meal

Participants will be served a large meal serving. They will be instructed to eat until they do not feel hungry anymore.

Intervention Type OTHER

Liquid meal

A standardized mixed liquid meal will be ingested to stimulate endogenous peptide hormone release

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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Copenhagen University Hospital, Hvidovre

OTHER

Sponsor Role collaborator

University of Copenhagen

OTHER

Sponsor Role lead

Responsible Party

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Simon Veedfald

Principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Hvidovre University Hospital

Hvidovre, Capital, Denmark

Site Status

Countries

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Denmark

Other Identifiers

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Neurotensin BMI/HH 2017 UCPH

Identifier Type: -

Identifier Source: org_study_id

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