Neurotensin - an Important Regulator of Appetite in Humans? (NIRAH)

November 7, 2019 updated by: Simon Veedfald, University of Copenhagen

The Effect of Neurotensin on Appetite, Food Intake, Blood Glucose Regulation, Hormone Secretion, and the Degradation of Neurotensin in Vivo

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

18

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
    • Capital
      • Hvidovre, Capital, Denmark, 2650
        • Hvidovre University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 46 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Saline + ad libitum meal
This will serve as the placebo / control day for the NT + ad libitum meal study day.
Other: Saline
Intravenous infusion of saline
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.
Experimental: NT + ad libitum meal
Neurotensin (NT) infusion followed by an ad libitum meal to study the effect of NT on ad libitum food intake.
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.
Other: Neurotensin
Intravenous infusion of neurotensin
Experimental: 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.
Other: Saline
Intravenous infusion of saline
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.
Other: Liquid meal
A standardized mixed liquid meal will be ingested to stimulate endogenous peptide hormone release
Experimental: 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.
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.
Other: Neurotensin
Intravenous infusion of neurotensin
Other: Liquid meal
A standardized mixed liquid meal will be ingested to stimulate endogenous peptide hormone release
Experimental: Neurotensin
Acclimatization day
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.
Other: Neurotensin
Intravenous infusion of neurotensin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Ad libitum food intake (ad libitum days)
Time Frame: 60 min
Neurotensin (NT) and saline will be infused on two occasions in random order, double blinded. After 1h of infusion an ad libitum meal will be served. When the meal is completed food intake will be determined by weighing the leftovers.
60 min
Ad libitum food intake (liquid meal + ad libitum days)
Time Frame: 240 min
Neurotensin (NT) and saline will be infused on two occasions in random order, double blinded. 1h into the infusions a standardized liquid mixed meal will be ingested. After another 180 min an ad libitum meal will be served. When the meal is completed food intake will be determined by weighing the leftovers.
240 min

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Appetite and gastrointestinal sensations (ad libitum days)
Time Frame: -60, -15, 15, 30, 60, 90, 120 min

Using visual analogue scales (VAS) the effect of infusions and meals will be documented.

Ad libitum meals will also be evaluated using VAS.
-60, -15, 15, 30, 60, 90, 120 min
Appetite and gastrointestinal sensations (liquid meal + ad libitum days)
Time Frame: -60, -15, 15, 60, 90, 120, 150, 180, 210, 240 min

Using visual analogue scales (VAS) the effect of infusions and meals will be documented.

Ad libitum meals will also be evaluated using VAS.
-60, -15, 15, 60, 90, 120, 150, 180, 210, 240 min
Plasma glucose (ad libitum days)
Time Frame: -60, -30, -15, -1, 0- , 15, 30, 45, 60, 75, 90, 105, 120 min
Bed-side measurements of plasma glucose
-60, -30, -15, -1, 0- , 15, 30, 45, 60, 75, 90, 105, 120 min
Plasma glucose (liquid meal + ad libitum days)
Time Frame: -60, -30, -15, -1, 0- , 15, 30, 45, 60, 75, 90, 105, 120, 135, 150, 180, 240 min
Bed-side measurements of plasma glucose
-60, -30, -15, -1, 0- , 15, 30, 45, 60, 75, 90, 105, 120, 135, 150, 180, 240 min
Neurotensin (ad libitum days)
Time Frame: -60, -30, -15, -1, 0- , 15, 30, 45, 60, 75, 90, 105, 120 min
Plasma analysis
-60, -30, -15, -1, 0- , 15, 30, 45, 60, 75, 90, 105, 120 min
Neurotensin (liquid meal + ad libitum days)
Time Frame: -60, -30, -15, -1, 0- , 15, 30, 45, 60, 75, 90, 105, 120, 135, 150, 180, 240 min
Plasma analysis
-60, -30, -15, -1, 0- , 15, 30, 45, 60, 75, 90, 105, 120, 135, 150, 180, 240 min
Insulin (liquid meal + ad libitum days)
Time Frame: -60, -15, 15, 60, 90, 120, 150, 180, 210, 240 min
Serum analysis
-60, -15, 15, 60, 90, 120, 150, 180, 210, 240 min
Bile acids (ad libitum days)
Time Frame: -60, -30, -15, -1, 0- , 15, 30, 45, 60, 75, 90, 105, 120 min
Plasma analysis
-60, -30, -15, -1, 0- , 15, 30, 45, 60, 75, 90, 105, 120 min
bile acids (liquid meal + ad libitum days)
Time Frame: -60, -15, 15, 60, 90, 120, 150, 180, 210, 240 min
Plasma analysis
-60, -15, 15, 60, 90, 120, 150, 180, 210, 240 min
Ghrelin (ad libitum days)
Time Frame: -60, -30, -15, -1, 0- , 15, 30, 45, 60, 75, 90, 105, 120 min
Plasma analysis
-60, -30, -15, -1, 0- , 15, 30, 45, 60, 75, 90, 105, 120 min
Ghrelin (liquid meal + ad libitum days)
Time Frame: -60, -15, 15, 60, 90, 120, 150, 180, 210, 240 min
Plasma analysis
-60, -15, 15, 60, 90, 120, 150, 180, 210, 240 min
Glucagon-like peptide-1 (GLP-1) (ad libitum days)
Time Frame: -60, -30, -15, -1, 0- , 15, 30, 45, 60, 75, 90, 105, 120 min
Plasma analysis
-60, -30, -15, -1, 0- , 15, 30, 45, 60, 75, 90, 105, 120 min
Glucagon-like peptide-1 (GLP-1) (liquid meal + ad libitum days)
Time Frame: -60, -15, 15, 60, 90, 120, 150, 180, 210, 240 min
Plasma analysis
-60, -15, 15, 60, 90, 120, 150, 180, 210, 240 min
Glucose-dependent insulinotropic polypeptide (GIP) (liquid meal + ad libitum days)
Time Frame: -60, -15, 15, 60, 90, 120, 150, 180, 210, 240 min
Plasma analysis
-60, -15, 15, 60, 90, 120, 150, 180, 210, 240 min
Peptide YY (PYY) (liquid meal + ad libitum days)
Time Frame: -60, -15, 15, 60, 90, 120, 150, 180, 210, 240 min
Plasma analysis
-60, -15, 15, 60, 90, 120, 150, 180, 210, 240 min
Paracetamol (liquid meal + ad libitum days)
Time Frame: -60, -15, 15, 60, 90, 120, 150, 180, 210, 240 min
Serum analyses
-60, -15, 15, 60, 90, 120, 150, 180, 210, 240 min
Pancreatic polypeptide (PP) (liquid meal + ad libitum days)
Time Frame: -60, -15, 15, 60, 90, 120, 150, 180, 210, 240 min
Plasma analysis
-60, -15, 15, 60, 90, 120, 150, 180, 210, 240 min
Pancreatic polypeptide (PP) (ad libitum days)
Time Frame: -60, -30, -15, -1, 0- , 15, 30, 45, 60, 75, 90, 105, 120 min
Plasma analysis
-60, -30, -15, -1, 0- , 15, 30, 45, 60, 75, 90, 105, 120 min
Cholecystokinin (CCK) (ad libitum days)
Time Frame: -60, -30, -15, -1, 0- , 15, 30, 45, 60, 75, 90, 105, 120 min
Plasma analysis
-60, -30, -15, -1, 0- , 15, 30, 45, 60, 75, 90, 105, 120 min
Cholecystokinin (CCK) (liquid meal + ad libitum days)
Time Frame: -60, -15, 15, 60, 90, 120, 150, 180, 210, 240 min
Plasma analysis
-60, -15, 15, 60, 90, 120, 150, 180, 210, 240 min

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Copenhagen

Collaborators

Copenhagen University Hospital, Hvidovre

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 5, 2018

Primary Completion (Actual)

May 1, 2019

Study Completion (Anticipated)

December 1, 2019

Study Registration Dates

First Submitted

December 14, 2017

First Submitted That Met QC Criteria

April 30, 2018

First Posted (Actual)

May 11, 2018

Study Record Updates

Last Update Posted (Actual)

November 12, 2019

Last Update Submitted That Met QC Criteria

November 7, 2019

Last Verified

November 1, 2019

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • Neurotensin BMI/HH 2017 UCPH

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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