Neurotensin - an Important Regulator of Appetite in Humans?

University of Copenhagen18 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

TRIPLE

Enrollment

Conditions

Physiology - Regulation of Appetite and Food Intake

Interventions

NeurotensinOTHER

Intravenous infusion of neurotensin

SalineOTHER

Intravenous infusion of saline

Ad libitum mealOTHER

Participants will be served a large meal serving. They will be instructed to eat until they do not feel hungry anymore.

Eligibility

Sex: MALEMin age: 18 YearsMax age: 50 YearsHealthy volunteers:

Medical Language ↔ Plain English

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)

Locations (1)

Hvidovre University Hospital

Hvidovre, Capital, Denmark

Outcomes

Primary Outcomes

Ad libitum food intake (ad libitum days)

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.

Time frame: 60 min

Ad libitum food intake (liquid meal + ad libitum days)

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.

Time frame: 240 min

Secondary Outcomes

Appetite and gastrointestinal sensations (ad libitum days)

Using visual analogue scales (VAS) the effect of infusions and meals will be documented. Ad libitum meals will also be evaluated using VAS.

Time frame: -60, -15, 15, 30, 60, 90, 120 min

Appetite and gastrointestinal sensations (liquid meal + ad libitum days)

Using visual analogue scales (VAS) the effect of infusions and meals will be documented. Ad libitum meals will also be evaluated using VAS.

Time frame: -60, -15, 15, 60, 90, 120, 150, 180, 210, 240 min

Plasma glucose (ad libitum days)

Bed-side measurements of plasma glucose

Time frame: -60, -30, -15, -1, 0- , 15, 30, 45, 60, 75, 90, 105, 120 min

Plasma glucose (liquid meal + ad libitum days)

Bed-side measurements of plasma glucose

Time frame: -60, -30, -15, -1, 0- , 15, 30, 45, 60, 75, 90, 105, 120, 135, 150, 180, 240 min

Data from ClinicalTrials.gov

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