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Completed

NCT Number: NCT04179331

Neurotensin Infusions in Healthy Individuals -

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.

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Key information

Conditions

Healthy

Age range

18 year–50 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

hvidovre Hospital

Hvidovre, Capital, 2650, Denmark

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age = or above 18 years
  • normal haemoglobin levels
  • male
  • Informed consent

Exclusion criteria

  • 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)

Treatment and study plan

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.

Saline

Other

Isotonic saline will serve as a placebo.

Primary outcomes

  1. Food intake

    Time frame: From time point t=190-220 minutes

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

Secondary outcomes

  1. Hunger

    Time frame: -45, -15, 15, 45, 75, 105, 135, 165, 220, 250 minutes

    Visual analogue scale (100mm)

  2. Satiation

    Time frame: -45, -15, 15, 45, 75, 105, 135, 165, 220, 250 minutes

    Visual analogue scale (100mm)

  3. Fullness

    Time frame: -45, -15, 15, 45, 75, 105, 135, 165, 220, 250 minutes

    Visual analogue scale (100mm)

  4. Prospective food intake

    Time frame: -45, -15, 15, 45, 75, 105, 135, 165, 220, 250 minutes

    Visual analogue scale (100mm)

  5. Comfort

    Time frame: -45, -15, 15, 45, 75, 105, 135, 165, 220, 250 minutes

    Visual analogue scale (100mm)

  6. Thirst

    Time frame: -45, -15, 15, 45, 75, 105, 135, 165, 220, 250 minutes

    Visual analogue scale (100mm)

  7. Neurotensin

    Time frame: -60, -30, -15, 0, 15, 30, 60, 75, 90, 120, 135, 150, 180, 220 minutes

    plasma concentration (intact and total)

  8. Pancreatic polypeptide

    Time frame: -60, -30, -15, 0, 15, 30, 60, 75, 90, 120, 135, 150, 180, 220 minutes

    Plasma concentration (intact and total)

  9. Glucagon

    Time frame: -60, -30, -15, 0, 15, 30, 60, 75, 90, 120, 135, 150, 180, 220 minutes

    Plasma concentration

  10. insulin and C-peptide

    Time frame: -60, -30, -15, 0, 15, 30, 60, 75, 90, 120, 135, 150, 180, 220 minutes

    Serum concentration

  11. Heart rate

    Time frame: -60 to 250 minutes

    Pulse rate every 10 min

  12. Blood pressure

    Time frame: -60 to 250 minutes

    Systolic and diastolic blood pressures (mmHg) every 10 minutes

Sponsors and collaborators

Lead sponsor

University of Copenhagen

Other

Collaborators

  • Hvidovre University Hospital

Registry information

Official study title

Neurotensin Infusions in Healthy Individuals - Effects on Appetite, Food Intake, Hormone Secretions and Cardiovascular Responses

Acronym: NIHI

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Nov 27, 2019
Registry last updated
Jun 7, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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