Neurotensin Infusions in Healthy Individuals - (NIHI)

University of Copenhagen

Status: Completed

Conditions: Healthy

Treatments: Other: Neurotensin; Other: Saline

Study type: Interventional

Funder types: Other

Identifiers

NCT04179331

NT-2-19

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.

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.

Enrollment: 9 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

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9 participants in 2 patient groups

Neurotensin

Experimental group

Treatment:

Other: Neurotensin

Saline

Experimental group

Treatment:

Other: Saline