NIHI: Neurotensin Infusions in Healthy Individuals -

Sponsor

University of Copenhagen (Other)

Overall Status

Completed

CT.gov ID

NCT04179331

Collaborator

Hvidovre University Hospital (Other)

Enrollment

Location

Arms

10.8

Actual Duration (Months)

0.8

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

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.

Condition or Disease	Intervention/Treatment	Phase
Healthy	Other: Neurotensin Other: Saline	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

9 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Intervention Model Description:

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

Masking:

Triple (Participant, Investigator, Outcomes Assessor)

Masking Description:

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

Primary Purpose:

Basic Science

Official Title:

Neurotensin Infusions in Healthy Individuals - Effects on Appetite, Food Intake, Hormone Secretions and Cardiovascular Responses

Actual Study Start Date :

Mar 1, 2019

Actual Primary Completion Date :

Jan 23, 2020

Actual Study Completion Date :

Jan 23, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Neurotensin	Other: 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.
Experimental: Saline	Other: Saline Isotonic saline will serve as a placebo.

Arm

Intervention/Treatment

Experimental: Neurotensin

Other: 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.

Experimental: Saline

Other: Saline

Isotonic saline will serve as a placebo.

Outcome Measures

Primary Outcome Measures

Food intake [From time point t=190-220 minutes]
The amount of food ingested over 30 minutes will be determined.

Secondary Outcome Measures

Hunger [-45, -15, 15, 45, 75, 105, 135, 165, 220, 250 minutes]
Visual analogue scale (100mm)
Satiation [-45, -15, 15, 45, 75, 105, 135, 165, 220, 250 minutes]
Visual analogue scale (100mm)
Fullness [-45, -15, 15, 45, 75, 105, 135, 165, 220, 250 minutes]
Visual analogue scale (100mm)
Prospective food intake [-45, -15, 15, 45, 75, 105, 135, 165, 220, 250 minutes]
Visual analogue scale (100mm)
Comfort [-45, -15, 15, 45, 75, 105, 135, 165, 220, 250 minutes]
Visual analogue scale (100mm)
Thirst [-45, -15, 15, 45, 75, 105, 135, 165, 220, 250 minutes]
Visual analogue scale (100mm)
Neurotensin [-60, -30, -15, 0, 15, 30, 60, 75, 90, 120, 135, 150, 180, 220 minutes]
plasma concentration (intact and total)
Pancreatic polypeptide [-60, -30, -15, 0, 15, 30, 60, 75, 90, 120, 135, 150, 180, 220 minutes]
Plasma concentration (intact and total)
Glucagon [-60, -30, -15, 0, 15, 30, 60, 75, 90, 120, 135, 150, 180, 220 minutes]
Plasma concentration
insulin and C-peptide [-60, -30, -15, 0, 15, 30, 60, 75, 90, 120, 135, 150, 180, 220 minutes]
Serum concentration
Heart rate [-60 to 250 minutes]
Pulse rate every 10 min
Blood pressure [-60 to 250 minutes]
Systolic and diastolic blood pressures (mmHg) every 10 minutes

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 50 Years

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

Yes

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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	hvidovre Hospital	Hvidovre	Capital	Denmark	2650

Sponsors and Collaborators

University of Copenhagen
Hvidovre University Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Simon Veedfald, Primary investigator, University of Copenhagen

ClinicalTrials.gov Identifier:

NCT04179331

Other Study ID Numbers:

NT-2-19

First Posted:

Nov 27, 2019

Last Update Posted:

Jun 7, 2021

Last Verified:

Jun 1, 2021

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Simon Veedfald, Primary investigator, University of Copenhagen

Study Results

No Results Posted as of Jun 7, 2021