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

Obesity Clinical Trial

Official title:

Effect of Combination of the Gut Hormones Neurotensin and GLP-1 on Physiological Regulation of Appetite and Food Intake

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04186026
• Other study ID #: 514-0386/19-3000
• Status: Recruiting
• Phase: N/A
• Start date: October 1, 2019
• Est. completion date: June 30, 2024

Study information

• Verified date: May 2023
• Source: University of Copenhagen
• Contact: Birgitte Holst, PhD, Professor
• Phone: +4521487699
• Email: holst[@]sund.ku.dk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 35
• Est. completion date: June 30, 2024
• Est. primary completion date: June 10, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Obesity

Intervention

Other:
• Saline + saline
Double saline infusion followed by an ad libitum meal
• Neurotensin + saline
Neurotensin + saline infusion followed by an ad libitum meal
• GLP-1 + saline
GLP-1 + saline infusion followed by an ad libitum meal
• GLP-1 + Neurotensin
GLP-1 + Neurotensin infusion followed by an ad libitum meal

Locations

Country	Name	City	State
Denmark	Copenhagen University Hospital Hvidovre	Copenhagen
Denmark	University of Copenhagen, Department of Biomedical Scienses	Copenhagen

Sponsors (2)

Lead Sponsor	Collaborator
University of Copenhagen	Copenhagen University Hospital, Hvidovre

Country where clinical trial is conducted

Denmark, 

Outcome

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