Clinical trial NCT04186026: Co-infusion of Neurotensin and GLP-1 Effects on Appetite and Food Intake.
Official title: Effect of Combination of the Gut Hormones Neurotensin and GLP-1 on Physiological Regulation of Appetite and Food Intake
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Obesity
Keywords: Neurotensin
Glucagon like peptide-1 (GLP-1)
Lead sponsor: University of Copenhagen
Sponsor class: OTHER
Collaborators: name: Copenhagen University Hospital, Hvidovre
First posted: 2019-12-04
Enrollment: 35
Sex: MALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Participants will be studied on multiple occasions (4 days) in a randomised and double blinded fashion.
Primary purpose: BASIC_SCIENCE

Brief summary: Co-infusion of Neurotensin and GLP-1 Effects on Appetite and Food Intake.

Detailed description: Neurotensin (NT), a gut hormone and neuropeptide, and GLP-1, as well a gut hormone, increases in circulation after bariatric surgery in rodents and humans and inhibit food intake in mice.

Studies in rodents have shown that a GLP-1 receptor agonist and long acting neurotensin inhibit food intake.

This study investigates whether the synergistic anorexic effects of neurotensin and GLP-1 agonism suggested by animal studies can be translated.

Eligibility criteria: Inclusion Criteria:

* Informed consent
* Above 18 years of age
* Normal hemoglobin concentration
* 28\<BMI\<40 kg/m2

Exclusion Criteria:

* Diabetes mellitus
* Truncal vagotomy
* Resection of intestine (apart from appendectomy)
* Tobaccos use
* Nephropathy (serum-creatinin\>130 micromolar or/and albuminuria)
* Liver disease (Alanine transaminase or/and aspartate transaminase\>2 times normal range.)
* Treatment with medication that cannot be paused in 12 hours
* Allergy towards latex or plastic
* Bleeding disorder

Primary outcomes:
measure: Ad-libitum food intake
timeFrame: 120 min
Secondary outcomes:
measure: Appetite and gastrointestinal sensations
timeFrame: -60, -30, 0, 30, 60, 90, 120, 150 and 180 min
measure: Plasma glucose
timeFrame: -60, -30, 0, 15, 30, 45, 60, 90, 120, 150, 165 and 180 min
measure: Neurotensin
timeFrame: -60, -30, 0, 15, 30, 45, 60, 90, 120, 150, 165 and 180 min
measure: GLP-1
timeFrame: -60, -30, 0, 15, 30, 45, 60, 90, 120, 150, 165 and 180 min
measure: Insulin
timeFrame: -60, -30, 0, 15, 30, 45, 60, 90, 120, 150, 165 and 180 min
measure: C-peptide
timeFrame: -60, -30, 0, 15, 30, 45, 60, 90, 120, 150, 165 and 180 min
measure: Bile acids
timeFrame: -60, -30, 0, 15, 30, 45, 60, 90, 120, 150, 165 and 180 min
measure: Ghrelin
timeFrame: -60, -30, 0, 15, 30, 45, 60, 90, 120, 150, 165 and 180 min
measure: Peptide YY (PYY)
timeFrame: -60, -30, 0, 15, 30, 45, 60, 90, 120, 150, 165 and 180 min
measure: Leptin
timeFrame: -60, -30, 0, 15, 30, 45, 60, 90, 120, 150, 165 and 180 min
measure: Metabolomics
timeFrame: -60, -30, 0, 15, 30, 45, 60, 90, 120, 150, 165 and 180 min
measure: Proteomics
timeFrame: -60, -30, 0, 15, 30, 45, 60, 90, 120, 150, 165 and 180 min
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: University of Copenhagen, Department of Biomedical Scienses
city: Copenhagen
country: Denmark
facility: Copenhagen University Hospital Hvidovre
Study officials:
References: