Neurotensin - an Important Regulator of Appetite in Humans?

Not Applicable

• Conditions: Physiology - Regulation of Appetite and Food Intake
• Interventions: Other: Saline; Other: Neurotensin; Other: Ad libitum meal; Other: Liquid meal

• Registration Number: NCT03522792
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-12-14
• Study Start: 2018-01-05
• Study First Submitted QC: 2018-04-30
• Study First Posted: 2018-05-11
• Primary Completion: 2019-05-01
• Status Verified: 2019-11
• Last Update Submitted: 2019-11-07
• Last Update Posted: 2019-11-12
• Study Completion: 2019-12-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Male
• Target Recruitment: 18

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Saline + ad libitum meal	Saline	This will serve as the placebo / control day for the NT + ad libitum meal study day.
NT + ad libitum meal	Neurotensin	Neurotensin (NT) infusion followed by an ad libitum meal to study the effect of NT on ad libitum food intake.
Saline + liquid meal + ad libitum 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.
Saline + liquid meal + ad libitum meal	Saline	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.
Saline + ad libitum meal	Ad libitum meal	This will serve as the placebo / control day for the NT + ad libitum meal study day.
NT + ad libitum meal	Ad libitum meal	Neurotensin (NT) infusion followed by an ad libitum meal to study the effect of NT on ad libitum food intake.
Neurotensin	Neurotensin	Acclimatization day
Saline + liquid meal + ad libitum meal	Liquid 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.
NT + liquid meal + ad libitum meal	Neurotensin	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.
NT + liquid meal + ad libitum 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.
NT + liquid meal + ad libitum meal	Liquid 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.
Neurotensin	Ad libitum meal	Acclimatization day

Primary Outcome Measures

Name	Time	Method
Ad libitum food intake (ad libitum days)	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.
Ad libitum food intake (liquid meal + ad libitum days)	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

Name	Time	Method
Appetite and gastrointestinal sensations (ad libitum days)	-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.
Appetite and gastrointestinal sensations (liquid meal + ad libitum days)	-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.
Plasma glucose (ad libitum days)	-60, -30, -15, -1, 0- , 15, 30, 45, 60, 75, 90, 105, 120 min	Bed-side measurements of plasma glucose
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	Bed-side measurements of plasma glucose
Neurotensin (ad libitum days)	-60, -30, -15, -1, 0- , 15, 30, 45, 60, 75, 90, 105, 120 min	Plasma analysis
Neurotensin (liquid meal + ad libitum days)	-60, -30, -15, -1, 0- , 15, 30, 45, 60, 75, 90, 105, 120, 135, 150, 180, 240 min	Plasma analysis
Insulin (liquid meal + ad libitum days)	-60, -15, 15, 60, 90, 120, 150, 180, 210, 240 min	Serum analysis
Bile acids (ad libitum days)	-60, -30, -15, -1, 0- , 15, 30, 45, 60, 75, 90, 105, 120 min	Plasma analysis
Glucose-dependent insulinotropic polypeptide (GIP) (liquid meal + ad libitum days)	-60, -15, 15, 60, 90, 120, 150, 180, 210, 240 min	Plasma analysis
Peptide YY (PYY) (liquid meal + ad libitum days)	-60, -15, 15, 60, 90, 120, 150, 180, 210, 240 min	Plasma analysis
Paracetamol (liquid meal + ad libitum days)	-60, -15, 15, 60, 90, 120, 150, 180, 210, 240 min	Serum analyses
Pancreatic polypeptide (PP) (liquid meal + ad libitum days)	-60, -15, 15, 60, 90, 120, 150, 180, 210, 240 min	Plasma analysis
Pancreatic polypeptide (PP) (ad libitum days)	-60, -30, -15, -1, 0- , 15, 30, 45, 60, 75, 90, 105, 120 min	Plasma analysis
Cholecystokinin (CCK) (ad libitum days)	-60, -30, -15, -1, 0- , 15, 30, 45, 60, 75, 90, 105, 120 min	Plasma analysis
Cholecystokinin (CCK) (liquid meal + ad libitum days)	-60, -15, 15, 60, 90, 120, 150, 180, 210, 240 min	Plasma analysis
bile acids (liquid meal + ad libitum days)	-60, -15, 15, 60, 90, 120, 150, 180, 210, 240 min	Plasma analysis
Ghrelin (ad libitum days)	-60, -30, -15, -1, 0- , 15, 30, 45, 60, 75, 90, 105, 120 min	Plasma analysis
Ghrelin (liquid meal + ad libitum days)	-60, -15, 15, 60, 90, 120, 150, 180, 210, 240 min	Plasma analysis
Glucagon-like peptide-1 (GLP-1) (ad libitum days)	-60, -30, -15, -1, 0- , 15, 30, 45, 60, 75, 90, 105, 120 min	Plasma analysis
Glucagon-like peptide-1 (GLP-1) (liquid meal + ad libitum days)	-60, -15, 15, 60, 90, 120, 150, 180, 210, 240 min	Plasma analysis

Trial Locations

Locations (1)

Hvidovre University Hospital; 🇩🇰 Hvidovre, Capital, Denmark