Neurotensin Infusions in Healthy Individuals -

Study Overview
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Brief Summary
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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.

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

Conditions
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Healthy

Intervention / Treatment
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* Other: Neurotensin
* Other: Saline


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: Acute physiological experiments conducted in healthy individuals in a University Hospital setting.
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Neurotensin<br> | Other: Neurotensin<br>* 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.<br>|
| Experimental: Saline<br> | Other: Saline<br>* Isotonic saline will serve as a placebo.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Food intake | The amount of food ingested over 30 minutes will be determined. | From time point t=190-220 minutes | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Appetite regulation, Food intake, Ad libitum, Hormone secretion