Neurotensin - an Important Regulator of Appetite in Humans? (NIRAH)
Status
Unknown
Conditions
Physiology - Regulation of Appetite and Food Intake
Treatments
Other: Ad libitum meal
Other: Saline
Other: Neurotensin
Other: Liquid meal
Details and patient eligibility
About
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.
Enrollment
18 estimated patients
Sex
Male
Ages
18 to 50 years old
Volunteers
Accepts Healthy Volunteers
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)
Trial design
Primary purpose
Basic Science
Allocation
Randomized
Interventional model
Crossover Assignment
Masking
Triple Blind
18 participants in 5 patient groups
Saline + ad libitum meal
Experimental group
Description:
This will serve as the placebo / control day for the NT + ad libitum meal study day.
Treatment:
Other: Ad libitum meal
Other: Saline
NT + ad libitum meal
Experimental group
Description:
Neurotensin (NT) infusion followed by an ad libitum meal to study the effect of NT on ad libitum food intake.
Treatment:
Other: Ad libitum meal
Other: Neurotensin
Saline + liquid meal + ad libitum meal
Experimental group
Description:
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.
Treatment:
Other: Ad libitum meal
Other: Saline
Other: Liquid meal
NT + liquid meal + ad libitum meal
Experimental group
Description:
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.
Treatment:
Other: Ad libitum meal
Other: Liquid meal
Other: Neurotensin
Neurotensin
Experimental group
Description:
Acclimatization day
Treatment:
Other: Ad libitum meal
Other: Neurotensin
Trial contacts and locations
1
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Data sourced from clinicaltrials.gov
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