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Neurotensin - an Important Regulator of Appetite in Humans? (NIRAH)

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ClinicalTrials.gov Identifier: NCT03522792
Recruitment Status : Recruiting
First Posted : May 11, 2018
Last Update Posted : May 11, 2018
Sponsor:
Collaborator:
Copenhagen University Hospital, Hvidovre
Information provided by (Responsible Party):
Simon Veedfald, University of Copenhagen

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.


Condition or disease Intervention/treatment Phase
Physiology - Regulation of Appetite and Food Intake Other: Neurotensin Other: Saline Other: Ad libitum meal Other: Liquid meal Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 18 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: Participants will be studied on multiple occasions (5 days) in a randomised and double blinded fashion. One day will serve as an acclimatization day.
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Masking Description: 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
Primary Purpose: Basic Science
Official Title: The Effect of Neurotensin on Appetite, Food Intake, Blood Glucose Regulation, Hormone Secretion, and the Degradation of Neurotensin in Vivo
Actual Study Start Date : January 5, 2018
Estimated Primary Completion Date : November 1, 2018
Estimated Study Completion Date : July 1, 2019

Arm Intervention/treatment
Experimental: Saline + ad libitum meal
This will serve as the placebo / control day for the NT + ad libitum meal study day.
Other: Saline
Intravenous infusion of saline

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

Experimental: NT + ad libitum meal
Neurotensin (NT) infusion followed by an ad libitum meal to study the effect of NT on ad libitum food intake.
Other: Neurotensin
Intravenous infusion of neurotensin

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

Experimental: Saline + liquid meal + ad libitum meal
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
Intravenous infusion of saline

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

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

Experimental: NT + liquid meal + ad libitum meal
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
Intravenous infusion of neurotensin

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

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

Experimental: Neurotensin
Acclimatization day
Other: Neurotensin
Intravenous infusion of neurotensin

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




Primary Outcome Measures :
  1. Ad libitum food intake (ad libitum days) [ Time Frame: 60 min ]
    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.

  2. Ad libitum food intake (liquid meal + ad libitum days) [ Time Frame: 240 min ]
    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.


Secondary Outcome Measures :
  1. Appetite and gastrointestinal sensations (ad libitum days) [ Time Frame: -60, -15, 15, 30, 60, 90, 120 min ]

    Using visual analogue scales (VAS) the effect of infusions and meals will be documented.

    Ad libitum meals will also be evaluated using VAS.


  2. Appetite and gastrointestinal sensations (liquid meal + ad libitum days) [ Time Frame: -60, -15, 15, 60, 90, 120, 150, 180, 210, 240 min ]

    Using visual analogue scales (VAS) the effect of infusions and meals will be documented.

    Ad libitum meals will also be evaluated using VAS.


  3. Plasma glucose (ad libitum days) [ Time Frame: -60, -30, -15, -1, 0- , 15, 30, 45, 60, 75, 90, 105, 120 min ]
    Bed-side measurements of plasma glucose

  4. Plasma glucose (liquid meal + ad libitum days) [ Time Frame: -60, -30, -15, -1, 0- , 15, 30, 45, 60, 75, 90, 105, 120, 135, 150, 180, 240 min ]
    Bed-side measurements of plasma glucose

  5. Neurotensin (ad libitum days) [ Time Frame: -60, -30, -15, -1, 0- , 15, 30, 45, 60, 75, 90, 105, 120 min ]
    Plasma analysis

  6. Neurotensin (liquid meal + ad libitum days) [ Time Frame: -60, -30, -15, -1, 0- , 15, 30, 45, 60, 75, 90, 105, 120, 135, 150, 180, 240 min ]
    Plasma analysis

  7. Insulin (liquid meal + ad libitum days) [ Time Frame: -60, -15, 15, 60, 90, 120, 150, 180, 210, 240 min ]
    Serum analysis

  8. Bile acids (ad libitum days) [ Time Frame: -60, -30, -15, -1, 0- , 15, 30, 45, 60, 75, 90, 105, 120 min ]
    Plasma analysis

  9. bile acids (liquid meal + ad libitum days) [ Time Frame: -60, -15, 15, 60, 90, 120, 150, 180, 210, 240 min ]
    Plasma analysis

  10. Ghrelin (ad libitum days) [ Time Frame: -60, -30, -15, -1, 0- , 15, 30, 45, 60, 75, 90, 105, 120 min ]
    Plasma analysis

  11. Ghrelin (liquid meal + ad libitum days) [ Time Frame: -60, -15, 15, 60, 90, 120, 150, 180, 210, 240 min ]
    Plasma analysis

  12. Glucagon-like peptide-1 (GLP-1) (ad libitum days) [ Time Frame: -60, -30, -15, -1, 0- , 15, 30, 45, 60, 75, 90, 105, 120 min ]
    Plasma analysis

  13. Glucagon-like peptide-1 (GLP-1) (liquid meal + ad libitum days) [ Time Frame: -60, -15, 15, 60, 90, 120, 150, 180, 210, 240 min ]
    Plasma analysis

  14. Glucose-dependent insulinotropic polypeptide (GIP) (liquid meal + ad libitum days) [ Time Frame: -60, -15, 15, 60, 90, 120, 150, 180, 210, 240 min ]
    Plasma analysis

  15. Peptide YY (PYY) (liquid meal + ad libitum days) [ Time Frame: -60, -15, 15, 60, 90, 120, 150, 180, 210, 240 min ]
    Plasma analysis

  16. Paracetamol (liquid meal + ad libitum days) [ Time Frame: -60, -15, 15, 60, 90, 120, 150, 180, 210, 240 min ]
    Serum analyses

  17. Pancreatic polypeptide (PP) (liquid meal + ad libitum days) [ Time Frame: -60, -15, 15, 60, 90, 120, 150, 180, 210, 240 min ]
    Plasma analysis

  18. Pancreatic polypeptide (PP) (ad libitum days) [ Time Frame: -60, -30, -15, -1, 0- , 15, 30, 45, 60, 75, 90, 105, 120 min ]
    Plasma analysis

  19. Cholecystokinin (CCK) (ad libitum days) [ Time Frame: -60, -30, -15, -1, 0- , 15, 30, 45, 60, 75, 90, 105, 120 min ]
    Plasma analysis

  20. Cholecystokinin (CCK) (liquid meal + ad libitum days) [ Time Frame: -60, -15, 15, 60, 90, 120, 150, 180, 210, 240 min ]
    Plasma analysis



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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03522792


Locations
Denmark
Hvidovre University Hospital Recruiting
Hvidovre, Capital, Denmark, 2650
Contact: Simon Veedfald, MD    +45 41 10 25 95    veedfald@sund.ku.dk   
Contact: Steen Madsbad, Dr.Med.Sci       sten.madsbad@regionh.dk   
Sponsors and Collaborators
University of Copenhagen
Copenhagen University Hospital, Hvidovre

Responsible Party: Simon Veedfald, Principal investigator, University of Copenhagen
ClinicalTrials.gov Identifier: NCT03522792     History of Changes
Other Study ID Numbers: Neurotensin BMI/HH 2017 UCPH
First Posted: May 11, 2018    Key Record Dates
Last Update Posted: May 11, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Simon Veedfald, University of Copenhagen:
food intake
appetite
obesity treatment
neurotensin
gastrointestinal
peptide