Co-infusion of Neurotensin and GLP-1 Effects on Appetite and Food Intake.

NCT ID: NCT04186026

Last Updated: 2023-05-17

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

35 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-10-01

Study Completion Date

2024-06-30

Brief Summary

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Co-infusion of Neurotensin and GLP-1 Effects on Appetite and Food Intake.

Detailed Description

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Neurotensin (NT), a gut hormone and neuropeptide, and GLP-1, as well a gut hormone, increases in circulation after bariatric surgery in rodents and humans and inhibit food intake in mice.

Studies in rodents have shown that a GLP-1 receptor agonist and long acting neurotensin inhibit food intake.

This study investigates whether the synergistic anorexic effects of neurotensin and GLP-1 agonism suggested by animal studies can be translated.

Conditions

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Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Participants will be studied on multiple occasions (4 days) in a randomised and double blinded fashion.
Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators
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 humane serum albumine (HSA) or isotonic saline with HSA + neurotensin or isotonic saline with HSA + GLP-1) prepared by a designated colleague

Study Groups

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Saline+Saline

Group Type OTHER

Saline + saline

Intervention Type OTHER

Double saline infusion followed by an ad libitum meal

Neurotensin+Saline

Group Type OTHER

Neurotensin + saline

Intervention Type OTHER

Neurotensin + saline infusion followed by an ad libitum meal

GLP-1+Saline

Group Type OTHER

GLP-1 + saline

Intervention Type OTHER

GLP-1 + saline infusion followed by an ad libitum meal

Neurotensin + GLP-1

Group Type OTHER

GLP-1 + Neurotensin

Intervention Type OTHER

GLP-1 + Neurotensin infusion followed by an ad libitum meal

Interventions

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Saline + saline

Double saline infusion followed by an ad libitum meal

Intervention Type OTHER

Neurotensin + saline

Neurotensin + saline infusion followed by an ad libitum meal

Intervention Type OTHER

GLP-1 + saline

GLP-1 + saline infusion followed by an ad libitum meal

Intervention Type OTHER

GLP-1 + Neurotensin

GLP-1 + Neurotensin infusion followed by an ad libitum meal

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Informed consent
* Above 18 years of age
* Normal hemoglobin concentration
* 28\<BMI\<40 kg/m2

Exclusion Criteria

* Diabetes mellitus
* Truncal vagotomy
* Resection of intestine (apart from appendectomy)
* Tobaccos use
* Nephropathy (serum-creatinin\>130 micromolar or/and albuminuria)
* Liver disease (Alanine transaminase or/and aspartate transaminase\>2 times normal range.)
* Treatment with medication that cannot be paused in 12 hours
* Allergy towards latex or plastic
* Bleeding disorder
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 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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Birgitte Holst

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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University of Copenhagen, Department of Biomedical Scienses

Copenhagen, , Denmark

Site Status RECRUITING

Copenhagen University Hospital Hvidovre

Copenhagen, , Denmark

Site Status RECRUITING

Countries

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Denmark

Central Contacts

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Birgitte Holst, PhD, Professor

Role: CONTACT

+4521487699

Sten Madsbad, DMsc, Professor

Role: CONTACT

+4521691911

Facility Contacts

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Birgitte Holst, Professor

Role: primary

+4521487699

Sten Madsbad, Professor

Role: primary

+4521691911

Other Identifiers

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514-0386/19-3000

Identifier Type: -

Identifier Source: org_study_id

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