Neurotensin Infusions in Healthy Individuals -

Healthy Clinical Trial

— NIHI  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04179331
• Other study ID #: NT-2-19
• Status: Completed
• Phase: N/A
• Start date: March 1, 2019
• Est. completion date: January 23, 2020

Study information

• Verified date: June 2021
• Source: University of Copenhagen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 9
• Est. completion date: January 23, 2020
• Est. primary completion date: January 23, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 50 Years

Eligibility

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)

Related Conditions & MeSH terms

• Healthy

Intervention

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.
• Saline
Isotonic saline will serve as a placebo.

Locations

Country	Name	City	State
Denmark	hvidovre Hospital	Hvidovre	Capital

Sponsors (2)

Lead Sponsor	Collaborator
University of Copenhagen	Hvidovre University Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Food intake	The amount of food ingested over 30 minutes will be determined.	From time point t=190-220 minutes
Secondary	Hunger	Visual analogue scale (100mm)	-45, -15, 15, 45, 75, 105, 135, 165, 220, 250 minutes
Secondary	Satiation	Visual analogue scale (100mm)	-45, -15, 15, 45, 75, 105, 135, 165, 220, 250 minutes
Secondary	Fullness	Visual analogue scale (100mm)	-45, -15, 15, 45, 75, 105, 135, 165, 220, 250 minutes
Secondary	Prospective food intake	Visual analogue scale (100mm)	-45, -15, 15, 45, 75, 105, 135, 165, 220, 250 minutes
Secondary	Comfort	Visual analogue scale (100mm)	-45, -15, 15, 45, 75, 105, 135, 165, 220, 250 minutes
Secondary	Thirst	Visual analogue scale (100mm)	-45, -15, 15, 45, 75, 105, 135, 165, 220, 250 minutes
Secondary	Neurotensin	plasma concentration (intact and total)	-60, -30, -15, 0, 15, 30, 60, 75, 90, 120, 135, 150, 180, 220 minutes
Secondary	Pancreatic polypeptide	Plasma concentration (intact and total)	-60, -30, -15, 0, 15, 30, 60, 75, 90, 120, 135, 150, 180, 220 minutes
Secondary	Glucagon	Plasma concentration	-60, -30, -15, 0, 15, 30, 60, 75, 90, 120, 135, 150, 180, 220 minutes
Secondary	insulin and C-peptide	Serum concentration	-60, -30, -15, 0, 15, 30, 60, 75, 90, 120, 135, 150, 180, 220 minutes
Secondary	Heart rate	Pulse rate every 10 min	-60 to 250 minutes
Secondary	Blood pressure	Systolic and diastolic blood pressures (mmHg) every 10 minutes	-60 to 250 minutes