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

NCT04186026 | Unknown DMC

• 1 other identifier: 514-0386/19-3000
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

Obesity

Keywords

Neurotensin; Glucagon like peptide-1 (GLP-1)

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (12)

• Appetite and gastrointestinal sensations

  -60, -30, 0, 30, 60, 90, 120, 150 and 180 min

• Plasma glucose

  -60, -30, 0, 15, 30, 45, 60, 90, 120, 150, 165 and 180 min

• Neurotensin

  -60, -30, 0, 15, 30, 45, 60, 90, 120, 150, 165 and 180 min

• GLP-1

  -60, -30, 0, 15, 30, 45, 60, 90, 120, 150, 165 and 180 min

• Insulin

  -60, -30, 0, 15, 30, 45, 60, 90, 120, 150, 165 and 180 min

Study Arms (4)

Saline+Saline

OTHER

Other: Saline + saline

Neurotensin+Saline

OTHER

Other: Neurotensin + saline

GLP-1+Saline

OTHER

Other: GLP-1 + saline

Neurotensin + GLP-1

OTHER

Other: GLP-1 + Neurotensin

Interventions

Saline + saline OTHER

Double saline infusion followed by an ad libitum meal

Saline+Saline

Neurotensin + saline OTHER

Neurotensin + saline infusion followed by an ad libitum meal

Neurotensin+Saline

GLP-1 + saline OTHER

GLP-1 + saline infusion followed by an ad libitum meal

GLP-1+Saline

GLP-1 + Neurotensin OTHER

GLP-1 + Neurotensin infusion followed by an ad libitum meal

Neurotensin + GLP-1

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Copenhagen: lead
• Copenhagen University Hospital, Hvidovre: collaborator

Study Sites (2)

University of Copenhagen, Department of Biomedical Scienses

Copenhagen, 2200, Denmark

RECRUITING

Copenhagen University Hospital Hvidovre

Copenhagen, 2650, Denmark

RECRUITING

MeSH Terms

Conditions

Obesity

Interventions

Sodium Chloride; Neurotensin; Glucagon-Like Peptide 1

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Nerve Tissue Proteins; Proteins; Glucagon-Like Peptides; Proglucagon; Gastrointestinal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Central Study Contacts

Birgitte Holst, PhD, Professor

CONTACT

+4521487699; holst@sund.ku.dk

Sten Madsbad, DMsc, Professor

CONTACT

+4521691911; sten.madsbad@regionh.dk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Participants will not be informed of the nature of the infusion they are administered on any of the study days. The investigator will be provided with an infusion (either isotonic saline with humane serum albumine (HSA) or isotonic saline with HSA + neurotensin or isotonic saline with HSA + GLP-1) prepared by a designated colleague
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Participants will be studied on multiple occasions (4 days) in a randomised and double blinded fashion.

Study Record Dates

• First Submitted: November 26, 2019
• First Posted: December 4, 2019
• Study Start: October 1, 2019
• Primary Completion: June 10, 2024
• Study Completion: June 30, 2024
• Last Updated: May 17, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

DK (2)