Neurotensin Infusions in Healthy Individuals -

Not Applicable

Completed

• Conditions: Healthy
• Interventions: Other: Saline; Other: Neurotensin

• Registration Number: NCT04179331
• Lead Sponsor: University of Copenhagen

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-03-01
• Study First Submitted: 2019-11-07
• Study First Submitted QC: 2019-11-26
• Study First Posted: 2019-11-27
• Primary Completion: 2020-01-23
• Study Completion: 2020-01-23
• Status Verified: 2021-06
• Last Update Submitted: 2021-06-02
• Last Update Posted: 2021-06-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 9

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Saline	Saline	-
Neurotensin	Neurotensin	-

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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)
Blood pressure	-60 to 250 minutes	Systolic and diastolic blood pressures (mmHg) every 10 minutes
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

Trial Locations

Locations (1)

hvidovre Hospital; 🇩🇰 Hvidovre, Capital, Denmark