Clinical trial NCT04179331: Neurotensin Infusions in Healthy Individuals -
Official title: Neurotensin Infusions in Healthy Individuals - Effects on Appetite, Food Intake, Hormone Secretions and Cardiovascular Responses
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: Appetite regulation
Food intake
Ad libitum
Hormone secretion
Lead sponsor: University of Copenhagen
Sponsor class: OTHER
Collaborators: name: Hvidovre University Hospital
First posted: 2019-11-27
Enrollment: 9
Sex: MALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Acute physiological experiments conducted in healthy individuals in a University Hospital setting.
Primary purpose: BASIC_SCIENCE

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.


Eligibility criteria: 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)

Primary outcomes:
measure: Food intake
timeFrame: From time point t=190-220 minutes
Secondary outcomes:
measure: Hunger
timeFrame: -45, -15, 15, 45, 75, 105, 135, 165, 220, 250 minutes
measure: Satiation
timeFrame: -45, -15, 15, 45, 75, 105, 135, 165, 220, 250 minutes
measure: Fullness
timeFrame: -45, -15, 15, 45, 75, 105, 135, 165, 220, 250 minutes
measure: Prospective food intake
timeFrame: -45, -15, 15, 45, 75, 105, 135, 165, 220, 250 minutes
measure: Comfort
timeFrame: -45, -15, 15, 45, 75, 105, 135, 165, 220, 250 minutes
measure: Thirst
timeFrame: -45, -15, 15, 45, 75, 105, 135, 165, 220, 250 minutes
measure: Neurotensin
timeFrame: -60, -30, -15, 0, 15, 30, 60, 75, 90, 120, 135, 150, 180, 220 minutes
measure: Pancreatic polypeptide
timeFrame: -60, -30, -15, 0, 15, 30, 60, 75, 90, 120, 135, 150, 180, 220 minutes
measure: Glucagon
timeFrame: -60, -30, -15, 0, 15, 30, 60, 75, 90, 120, 135, 150, 180, 220 minutes
measure: insulin and C-peptide
timeFrame: -60, -30, -15, 0, 15, 30, 60, 75, 90, 120, 135, 150, 180, 220 minutes
measure: Heart rate
timeFrame: -60 to 250 minutes
measure: Blood pressure
timeFrame: -60 to 250 minutes
Other outcomes:
Locations:
city: Hvidovre
country: Denmark
facility: hvidovre Hospital
state: Capital
Study officials:
References: