Neurotensin Infusions in Healthy Individuals -

NCT04179331 | Completed DMC

• 1 other identifier: NT-2-19
• Study Type: interventional
• Target: 9
• 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. In this study, after a 1h baseline period, three doses (2.5, 5.0 and 7.5pmol/kg/min) of NT will be administered in sequence each infusion lasting 1h. On a placebo day saline will be infused similarly 1h infusions. During the final infusion (7.5pmol/kg/min) an ad libitum meal will be ingested. During the experiments blood samples will be collected and subjective perceptions recorded using validated visual analogue scales.

Conditions

Healthy

Keywords

Appetite regulation; Food intake; Ad libitum; Hormone secretion

Outcome Measures

Primary Outcomes (1)

• Food intake

  The amount of food ingested over 30 minutes will be determined.

  From time point t=190-220 minutes

Secondary Outcomes (12)

• Hunger

  -45, -15, 15, 45, 75, 105, 135, 165, 220, 250 minutes

• Satiation

  -45, -15, 15, 45, 75, 105, 135, 165, 220, 250 minutes

• Fullness

  -45, -15, 15, 45, 75, 105, 135, 165, 220, 250 minutes

• Prospective food intake

  -45, -15, 15, 45, 75, 105, 135, 165, 220, 250 minutes

• Comfort

  -45, -15, 15, 45, 75, 105, 135, 165, 220, 250 minutes

Study Arms (2)

Neurotensin

EXPERIMENTAL

Other: Neurotensin

Saline

EXPERIMENTAL

Other: Saline

Interventions

Neurotensin OTHER

Neurotensin is an endogenous peptide released from the distal small intestine. It will be administered at three doses (2.5, 5.0 and 7.5pmol/kg/min), each for 1h, in sequence.

Neurotensin

Saline OTHER

Isotonic saline will serve as a placebo.

Saline

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
• Hvidovre University Hospital: collaborator

Study Sites (1)

hvidovre 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: Double blinded. Neither the investigators performing the experiments or the participants know the nature of the intervention on the two study days.
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Primary investigator

Model Details: Acute physiological experiments conducted in healthy individuals in a University Hospital setting.

Study Record Dates

• First Submitted: November 7, 2019
• First Posted: November 27, 2019
• Study Start: March 1, 2019
• Primary Completion: January 23, 2020
• Study Completion: January 23, 2020
• Last Updated: June 7, 2021

Record last verified: 2021-06

Locations

DK (1)