Clinical trial NCT03522792: Neurotensin - an Important Regulator of Appetite in Humans?
Official title: The Effect of Neurotensin on Appetite, Food Intake, Blood Glucose Regulation, Hormone Secretion, and the Degradation of Neurotensin in Vivo
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Physiology - Regulation of Appetite and Food Intake
Keywords: food intake
appetite
obesity treatment
neurotensin
gastrointestinal
peptide
Lead sponsor: University of Copenhagen
Sponsor class: OTHER
Collaborators: name: Copenhagen University Hospital, Hvidovre
First posted: 2018-05-11
Enrollment: 18
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: Participants will be studied on multiple occasions (5 days) in a randomised and double blinded fashion. One day will serve as an acclimatization day.
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.

This study investigates whether the anorexic effects of NT suggested by animal studies can be translated.


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: Ad libitum food intake (ad libitum days)
timeFrame: 60 min
measure: Ad libitum food intake (liquid meal + ad libitum days)
timeFrame: 240 min
Secondary outcomes:
measure: Appetite and gastrointestinal sensations (ad libitum days)
timeFrame: -60, -15, 15, 30, 60, 90, 120 min
measure: Appetite and gastrointestinal sensations (liquid meal + ad libitum days)
timeFrame: -60, -15, 15, 60, 90, 120, 150, 180, 210, 240 min
measure: Plasma glucose (ad libitum days)
timeFrame: -60, -30, -15, -1, 0- , 15, 30, 45, 60, 75, 90, 105, 120 min
measure: Plasma glucose (liquid meal + ad libitum days)
timeFrame: -60, -30, -15, -1, 0- , 15, 30, 45, 60, 75, 90, 105, 120, 135, 150, 180, 240 min
measure: Neurotensin (ad libitum days)
timeFrame: -60, -30, -15, -1, 0- , 15, 30, 45, 60, 75, 90, 105, 120 min
measure: Neurotensin (liquid meal + ad libitum days)
timeFrame: -60, -30, -15, -1, 0- , 15, 30, 45, 60, 75, 90, 105, 120, 135, 150, 180, 240 min
measure: Insulin (liquid meal + ad libitum days)
timeFrame: -60, -15, 15, 60, 90, 120, 150, 180, 210, 240 min
measure: Bile acids (ad libitum days)
timeFrame: -60, -30, -15, -1, 0- , 15, 30, 45, 60, 75, 90, 105, 120 min
measure: bile acids (liquid meal + ad libitum days)
timeFrame: -60, -15, 15, 60, 90, 120, 150, 180, 210, 240 min
measure: Ghrelin (ad libitum days)
timeFrame: -60, -30, -15, -1, 0- , 15, 30, 45, 60, 75, 90, 105, 120 min
measure: Ghrelin (liquid meal + ad libitum days)
timeFrame: -60, -15, 15, 60, 90, 120, 150, 180, 210, 240 min
measure: Glucagon-like peptide-1 (GLP-1) (ad libitum days)
timeFrame: -60, -30, -15, -1, 0- , 15, 30, 45, 60, 75, 90, 105, 120 min
measure: Glucagon-like peptide-1 (GLP-1) (liquid meal + ad libitum days)
timeFrame: -60, -15, 15, 60, 90, 120, 150, 180, 210, 240 min
measure: Glucose-dependent insulinotropic polypeptide (GIP) (liquid meal + ad libitum days)
timeFrame: -60, -15, 15, 60, 90, 120, 150, 180, 210, 240 min
measure: Peptide YY (PYY) (liquid meal + ad libitum days)
timeFrame: -60, -15, 15, 60, 90, 120, 150, 180, 210, 240 min
measure: Paracetamol (liquid meal + ad libitum days)
timeFrame: -60, -15, 15, 60, 90, 120, 150, 180, 210, 240 min
measure: Pancreatic polypeptide (PP) (liquid meal + ad libitum days)
timeFrame: -60, -15, 15, 60, 90, 120, 150, 180, 210, 240 min
measure: Pancreatic polypeptide (PP) (ad libitum days)
timeFrame: -60, -30, -15, -1, 0- , 15, 30, 45, 60, 75, 90, 105, 120 min
measure: Cholecystokinin (CCK) (ad libitum days)
timeFrame: -60, -30, -15, -1, 0- , 15, 30, 45, 60, 75, 90, 105, 120 min
measure: Cholecystokinin (CCK) (liquid meal + ad libitum days)
timeFrame: -60, -15, 15, 60, 90, 120, 150, 180, 210, 240 min
Other outcomes:
Locations:
city: Hvidovre
country: Denmark
facility: Hvidovre University Hospital
state: Capital
Study officials:
References: