Physiology - Regulation of Appetite and Food Intake Clinical Trial
— NIRAHOfficial title:
The Effect of Neurotensin on Appetite, Food Intake, Blood Glucose Regulation, Hormone Secretion, and the Degradation of Neurotensin in Vivo
| Verified date | November 2019 |
| Source | University of Copenhagen |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Active, not recruiting |
| Enrollment | 18 |
| Est. completion date | December 1, 2019 |
| Est. primary completion date | May 1, 2019 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Male |
| Age group | 18 Years to 50 Years |
| Eligibility |
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) |
| Country | Name | City | State |
|---|---|---|---|
| Denmark | Hvidovre University Hospital | Hvidovre | Capital |
| Lead Sponsor | Collaborator |
|---|---|
| University of Copenhagen | Copenhagen University Hospital, Hvidovre |
Denmark,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Ad libitum food intake (ad libitum days) | 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. | 60 min | |
| Primary | Ad libitum food intake (liquid meal + ad libitum days) | 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. | 240 min | |
| Secondary | Appetite and gastrointestinal sensations (ad libitum days) | Using visual analogue scales (VAS) the effect of infusions and meals will be documented. Ad libitum meals will also be evaluated using VAS. |
-60, -15, 15, 30, 60, 90, 120 min | |
| Secondary | Appetite and gastrointestinal sensations (liquid meal + ad libitum days) | Using visual analogue scales (VAS) the effect of infusions and meals will be documented. Ad libitum meals will also be evaluated using VAS. |
-60, -15, 15, 60, 90, 120, 150, 180, 210, 240 min | |
| Secondary | Plasma glucose (ad libitum days) | Bed-side measurements of plasma glucose | -60, -30, -15, -1, 0- , 15, 30, 45, 60, 75, 90, 105, 120 min | |
| Secondary | Plasma glucose (liquid meal + ad libitum days) | Bed-side measurements of plasma glucose | -60, -30, -15, -1, 0- , 15, 30, 45, 60, 75, 90, 105, 120, 135, 150, 180, 240 min | |
| Secondary | Neurotensin (ad libitum days) | Plasma analysis | -60, -30, -15, -1, 0- , 15, 30, 45, 60, 75, 90, 105, 120 min | |
| Secondary | Neurotensin (liquid meal + ad libitum days) | Plasma analysis | -60, -30, -15, -1, 0- , 15, 30, 45, 60, 75, 90, 105, 120, 135, 150, 180, 240 min | |
| Secondary | Insulin (liquid meal + ad libitum days) | Serum analysis | -60, -15, 15, 60, 90, 120, 150, 180, 210, 240 min | |
| Secondary | Bile acids (ad libitum days) | Plasma analysis | -60, -30, -15, -1, 0- , 15, 30, 45, 60, 75, 90, 105, 120 min | |
| Secondary | bile acids (liquid meal + ad libitum days) | Plasma analysis | -60, -15, 15, 60, 90, 120, 150, 180, 210, 240 min | |
| Secondary | Ghrelin (ad libitum days) | Plasma analysis | -60, -30, -15, -1, 0- , 15, 30, 45, 60, 75, 90, 105, 120 min | |
| Secondary | Ghrelin (liquid meal + ad libitum days) | Plasma analysis | -60, -15, 15, 60, 90, 120, 150, 180, 210, 240 min | |
| Secondary | Glucagon-like peptide-1 (GLP-1) (ad libitum days) | Plasma analysis | -60, -30, -15, -1, 0- , 15, 30, 45, 60, 75, 90, 105, 120 min | |
| Secondary | Glucagon-like peptide-1 (GLP-1) (liquid meal + ad libitum days) | Plasma analysis | -60, -15, 15, 60, 90, 120, 150, 180, 210, 240 min | |
| Secondary | Glucose-dependent insulinotropic polypeptide (GIP) (liquid meal + ad libitum days) | Plasma analysis | -60, -15, 15, 60, 90, 120, 150, 180, 210, 240 min | |
| Secondary | Peptide YY (PYY) (liquid meal + ad libitum days) | Plasma analysis | -60, -15, 15, 60, 90, 120, 150, 180, 210, 240 min | |
| Secondary | Paracetamol (liquid meal + ad libitum days) | Serum analyses | -60, -15, 15, 60, 90, 120, 150, 180, 210, 240 min | |
| Secondary | Pancreatic polypeptide (PP) (liquid meal + ad libitum days) | Plasma analysis | -60, -15, 15, 60, 90, 120, 150, 180, 210, 240 min | |
| Secondary | Pancreatic polypeptide (PP) (ad libitum days) | Plasma analysis | -60, -30, -15, -1, 0- , 15, 30, 45, 60, 75, 90, 105, 120 min | |
| Secondary | Cholecystokinin (CCK) (ad libitum days) | Plasma analysis | -60, -30, -15, -1, 0- , 15, 30, 45, 60, 75, 90, 105, 120 min | |
| Secondary | Cholecystokinin (CCK) (liquid meal + ad libitum days) | Plasma analysis | -60, -15, 15, 60, 90, 120, 150, 180, 210, 240 min |