Neurotensin - an Important Regulator of Appetite in Humans?

NCT03522792 | Unknown DMC

• 1 other identifier: Neurotensin BMI/HH 2017 UCPH
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

Neurotensin (NT) is a gut peptide released postprandially from the small intestine. It is known to exert a range of enterogastrone effects and in animal models it reduces food intake when administered by parenteral routes. This study investigates whether the anorexic effects of NT suggested by animal studies can be translated.

Conditions

Physiology - Regulation of Appetite and Food Intake

Keywords

food intake; appetite; obesity treatment; neurotensin; gastrointestinal; peptide

Outcome Measures

Primary Outcomes (2)

• Ad libitum food intake (ad libitum days)

  Neurotensin (NT) and saline will be infused on two occasions in random order, double blinded. After 1h of infusion an ad libitum meal will be served. When the meal is completed food intake will be determined by weighing the leftovers.

  60 min

• Ad libitum food intake (liquid meal + ad libitum days)

  Neurotensin (NT) and saline will be infused on two occasions in random order, double blinded. 1h into the infusions a standardized liquid mixed meal will be ingested. After another 180 min an ad libitum meal will be served. When the meal is completed food intake will be determined by weighing the leftovers.

  240 min

Secondary Outcomes (20)

• Appetite and gastrointestinal sensations (ad libitum days)

  -60, -15, 15, 30, 60, 90, 120 min

• Appetite and gastrointestinal sensations (liquid meal + ad libitum days)

  -60, -15, 15, 60, 90, 120, 150, 180, 210, 240 min

• Plasma glucose (ad libitum days)

  -60, -30, -15, -1, 0- , 15, 30, 45, 60, 75, 90, 105, 120 min

• Plasma glucose (liquid meal + ad libitum days)

  -60, -30, -15, -1, 0- , 15, 30, 45, 60, 75, 90, 105, 120, 135, 150, 180, 240 min

• Neurotensin (ad libitum days)

  -60, -30, -15, -1, 0- , 15, 30, 45, 60, 75, 90, 105, 120 min

Study Arms (5)

Saline + ad libitum meal

EXPERIMENTAL

This will serve as the placebo / control day for the NT + ad libitum meal study day.

Other: Saline; Other: Ad libitum meal

NT + ad libitum meal

EXPERIMENTAL

Neurotensin (NT) infusion followed by an ad libitum meal to study the effect of NT on ad libitum food intake.

Other: Neurotensin; Other: Ad libitum meal

Saline + liquid meal + ad libitum meal

EXPERIMENTAL

Saline infusion followed a standardized liquid mixed meal followed by an ad libitum meal. This will serve as the placebo / control day for the NT + standardized liquid mixed meal + ad libitum meal study day. Investigating the effect of NT on the second meal effect.

Other: Saline; Other: Ad libitum meal; Other: Liquid meal

NT + liquid meal + ad libitum meal

EXPERIMENTAL

NT infusion followed a standardized liquid mixed meal followed by an ad libitum meal. This study day aims to study the effect of NT on the second meal effect.

Other: Neurotensin; Other: Ad libitum meal; Other: Liquid meal

Neurotensin

EXPERIMENTAL

Acclimatization day

Other: Neurotensin; Other: Ad libitum meal

Interventions

Neurotensin OTHER

Intravenous infusion of neurotensin

NT + ad libitum meal; NT + liquid meal + ad libitum meal; Neurotensin

Saline OTHER

Intravenous infusion of saline

Saline + ad libitum meal; Saline + liquid meal + ad libitum meal

Ad libitum meal OTHER

Participants will be served a large meal serving. They will be instructed to eat until they do not feel hungry anymore.

NT + ad libitum meal; NT + liquid meal + ad libitum meal; Neurotensin; Saline + ad libitum meal; Saline + liquid meal + ad libitum meal

Liquid meal OTHER

A standardized mixed liquid meal will be ingested to stimulate endogenous peptide hormone release

NT + liquid meal + ad libitum meal; Saline + liquid meal + ad libitum meal

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• age = or above 18 years
• normal haemoglobin levels
• male
• informed consent

You may not qualify if:

• Diabetes mellitus (fasting plasma glucose or HbA1c)
• Familiy history of diabetes mellitus
• Intestinal disease (incl e.g. inflammatory bowel disease and malabsorbtion)
• Family history of inflammatory bowel disease
• Previous intestinal resection
• Body mass index (BMI) over 25 kg/m2
• Smoker
• Nephropathy (S-creatinine\> 130 μM)
• Liver disease (ALAT and/or ASAT \> 2 × upper normal limit)

Sponsors & Collaborators

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

Study Sites (1)

Hvidovre University Hospital

Hvidovre, Capital, 2650, Denmark

Location

MeSH Terms

Interventions

Neurotensin; Sodium Chloride

Intervention Hierarchy (Ancestors)

Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Nerve Tissue Proteins; Proteins; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• 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 HSA or isotonic salin with HSA + neurotensin) prepared by a designated colleague
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Model Details: Participants will be studied on multiple occasions (5 days) in a randomised and double blinded fashion. One day will serve as an acclimatization day.

Study Record Dates

• First Submitted: December 14, 2017
• First Posted: May 11, 2018
• Study Start: January 5, 2018
• Primary Completion: May 1, 2019
• Study Completion: December 1, 2019
• Last Updated: November 12, 2019

Record last verified: 2019-11

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)