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

Not Applicable

Recruiting

• Conditions: Obesity
• Interventions: Other: GLP-1 + Neurotensin; Other: GLP-1 + saline; Other: Saline + saline; Other: Neurotensin + saline

• Registration Number: NCT04186026
• Lead Sponsor: University of Copenhagen

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.

Study Timeline

• Study Start: 2019-10-01
• Study First Submitted: 2019-11-26
• Study First Submitted QC: 2019-12-02
• Study First Posted: 2019-12-04
• Status Verified: 2023-05
• Last Update Submitted: 2023-05-16
• Last Update Posted: 2023-05-17
• Primary Completion: 2024-06-10
• Study Completion: 2024-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Male
• Target Recruitment: 35

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Neurotensin + GLP-1	GLP-1 + Neurotensin	-
GLP-1+Saline	GLP-1 + saline	-
Saline+Saline	Saline + saline	-
Neurotensin+Saline	Neurotensin + saline	-

Primary Outcome Measures

Name	Time	Method
Ad-libitum food intake	120 min	Neurotensin (NT), saline, GLP-1 and GLP-1+Neurotensin will be infused on four occasions in random order, double blinded. After 2h of infusion an ad libitum meal will be served. When the meal is completed food intake will be determined by weighing the leftovers.

Secondary Outcome Measures

Name	Time	Method
Ghrelin	-60, -30, 0, 15, 30, 45, 60, 90, 120, 150, 165 and 180 min	Plasma analysis
Metabolomics	-60, -30, 0, 15, 30, 45, 60, 90, 120, 150, 165 and 180 min	Plasma analysis
Proteomics	-60, -30, 0, 15, 30, 45, 60, 90, 120, 150, 165 and 180 min	Plasma analysis
Appetite and gastrointestinal sensations	-60, -30, 0, 30, 60, 90, 120, 150 and 180 min	Using visual analogue scales (VAS) the effect of infusions and meals will be documented.; Ad libitum meals will also be evaluated using VAS.
Plasma glucose	-60, -30, 0, 15, 30, 45, 60, 90, 120, 150, 165 and 180 min	Bed-side measurements of plasma glucose
Neurotensin	-60, -30, 0, 15, 30, 45, 60, 90, 120, 150, 165 and 180 min	Plasma analysis
GLP-1	-60, -30, 0, 15, 30, 45, 60, 90, 120, 150, 165 and 180 min	Plasma analysis
Insulin	-60, -30, 0, 15, 30, 45, 60, 90, 120, 150, 165 and 180 min	Serum analysis
C-peptide	-60, -30, 0, 15, 30, 45, 60, 90, 120, 150, 165 and 180 min	Serum analysis
Leptin	-60, -30, 0, 15, 30, 45, 60, 90, 120, 150, 165 and 180 min	Plasma analysis
Bile acids	-60, -30, 0, 15, 30, 45, 60, 90, 120, 150, 165 and 180 min	Plasma analysis
Peptide YY (PYY)	-60, -30, 0, 15, 30, 45, 60, 90, 120, 150, 165 and 180 min	Plasma analysis

Trial Locations

Locations (2)

Copenhagen University Hospital Hvidovre; 🇩🇰 Copenhagen, Denmark

University of Copenhagen, Department of Biomedical Scienses; 🇩🇰 Copenhagen, Denmark