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

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

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

Study Overview

• Status: Recruiting
• Conditions: Obesity
• Intervention / Treatment: Other: Saline + saline; Other: Neurotensin + saline; Other: GLP-1 + saline; Other: GLP-1 + Neurotensin

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 Type: Interventional
• Enrollment (Anticipated): 35
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Birgitte Holst, PhD, Professor; Phone Number: +4521487699; Email: holst@sund.ku.dk
• Study Contact Backup: Name: Sten Madsbad, DMsc, Professor; Phone Number: +4521691911; Email: sten.madsbad@regionh.dk

Study Locations

• Denmark
  • Copenhagen, Denmark, 2200
    • Recruiting
    • University of Copenhagen, Department of Biomedical Scienses
    • Contact: Birgitte Holst, Professor; Phone Number: +4521487699; Email: holst@sund.ku.dk
  • Copenhagen, Denmark, 2650
    • Recruiting
    • Copenhagen University Hospital Hvidovre
    • Contact: Sten Madsbad, Professor; Phone Number: +4521691911; Email: sten.madsbad@regionh.dk
    • Principal Investigator: Sten Madsbad, Professor

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Saline+Saline	Other: Saline + saline; Double saline infusion followed by an ad libitum meal
Other: Neurotensin+Saline	Other: Neurotensin + saline; Neurotensin + saline infusion followed by an ad libitum meal
Other: GLP-1+Saline	Other: GLP-1 + saline; GLP-1 + saline infusion followed by an ad libitum meal
Other: Neurotensin + GLP-1	Other: GLP-1 + Neurotensin; GLP-1 + Neurotensin infusion followed by an ad libitum meal

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Plasma glucose	Bed-side measurements of plasma glucose	-60, -30, 0, 15, 30, 45, 60, 90, 120, 150, 165 and 180 min
Neurotensin	Plasma analysis	-60, -30, 0, 15, 30, 45, 60, 90, 120, 150, 165 and 180 min
GLP-1	Plasma analysis	-60, -30, 0, 15, 30, 45, 60, 90, 120, 150, 165 and 180 min
Insulin	Serum analysis	-60, -30, 0, 15, 30, 45, 60, 90, 120, 150, 165 and 180 min
C-peptide	Serum analysis	-60, -30, 0, 15, 30, 45, 60, 90, 120, 150, 165 and 180 min
Bile acids	Plasma analysis	-60, -30, 0, 15, 30, 45, 60, 90, 120, 150, 165 and 180 min
Ghrelin	Plasma analysis	-60, -30, 0, 15, 30, 45, 60, 90, 120, 150, 165 and 180 min
Peptide YY (PYY)	Plasma analysis	-60, -30, 0, 15, 30, 45, 60, 90, 120, 150, 165 and 180 min
Leptin	Plasma analysis	-60, -30, 0, 15, 30, 45, 60, 90, 120, 150, 165 and 180 min
Metabolomics	Plasma analysis	-60, -30, 0, 15, 30, 45, 60, 90, 120, 150, 165 and 180 min
Proteomics	Plasma analysis	-60, -30, 0, 15, 30, 45, 60, 90, 120, 150, 165 and 180 min

Collaborators and Investigators

• Sponsor: University of Copenhagen
• Collaborators: Copenhagen University Hospital, Hvidovre

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2019
• Primary Completion (Anticipated): June 10, 2024
• Study Completion (Anticipated): June 30, 2024

Study Registration Dates

• First Submitted: November 26, 2019
• First Submitted That Met QC Criteria: December 2, 2019
• First Posted (Actual): December 4, 2019

Study Record Updates

• Last Update Posted (Actual): May 17, 2023
• Last Update Submitted That Met QC Criteria: May 16, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: Neurotensin; Glucagon like peptide-1 (GLP-1)
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Gastrointestinal Agents; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Incretins; Glucagon; Glucagon-Like Peptide 1
• Other Study ID Numbers: 514-0386/19-3000

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No