Healthy
Conditions
Keywords
Gut hormone secretion, Glucose absorption, early meal phase, Insulin and glucagon secretion
Brief summary
To investigate gastrointestinal hormone secretions and nutrient absorption during the early meal phase we will recruit 12 healthy young men. They will be equipped with peripheral intravenous catheters for frequent blood sampling. Participants will be screened and acclimatised to the study situation on visit 1. On visit 2 and 3 participants will in random order ingest an oral glucose solution or a standardised liquid mixed meal over 2-3 min.
Interventions
OTHEROral glucose tolerance test
Oral glucose tolerance test will be carried out with a glucose solution made up of 75g glucose dissolved in 300mL. To the glucose solution will be added 5g 3-OMG and 1g paracetamol 5g 3-OMG
A standardised liquid mixed meal test will be carried out using a standard liquid mixed meal (fresubin drink supplemented with 1g paracetamol).
Sponsors
Rigshospitalet, Denmark
University of Copenhagen
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Intervention model description
12 healthy male individuals will each be studied on two occasions in random order. * oral glucose tolerance test * liquid mixed meal test
Eligibility
Sex/Gender
MALE
Age
18 Years to 40 Years
Healthy volunteers
Yes
Inclusion criteria
* Age between 18 and 40years * Male * Normal Haemoglobin concentration * Informed consent
Exclusion criteria
* Diabetes mellitus * Family history of diabetes mellitus * intestinal disease (for example inflammatory bowel disease or malabsorption) * Family history of inflammatory bowel disease * Previous intestinal resection (except uncomplicated appendicectomy) * Body mass index (BMI) \> 25 kg/m2 * Tobacco use * kidney disease (se-creatinine\> 130 µM and/or albuminuria) * liver disease (ALAT and/or ASAT \>2 × above normal range) * Heart disease * Treatment with drugs * History of constipation * Conditions with delayed or accelerated gastric emptying * Latex or other allergies * Bleeding diathesis
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Plasma GIP concentrations | -40, -20, -18, -16, -14, -12, -10, -8, -6, -4, -2, 0, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 30 min | Glucose-dependent insulinotropic polypeptide plasma concentrations |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Serum 3-OMG concentrations | -10, -2, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 30 | Serum 3-OMG concentrations (glucose absorption marker) |
| Serum C-peptide and insulin concentrations | -40, -20, -18, -16, -14, -12, -10, -8, -6, -4, -2, 0, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 30 min | Glucagon-like peptide-1 plasma concentrations |
| Plasma gastrin concentrations | -40, -20, -18, -16, -14, -12, -10, -8, -6, -4, -2, 0, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 30 min | Plasma gastrin concentrations |
| Plasma CCK concentrations | -40, -20, -18, -16, -14, -12, -10, -8, -6, -4, -2, 0, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 30 min | Plasma cholecystokinin concentrations |
| Plasma PP concentrations | -40, -20, -18, -16, -14, -12, -10, -8, -6, -4, -2, 0, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 30 min | Plasma pancreatic polypeptide concentrations |
| Plasma GLP-1 concentrations | -40, -20, -18, -16, -14, -12, -10, -8, -6, -4, -2, 0, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 30 min | Glucagon-like peptide-1 plasma concentrations |
| Plasma glucagon concentrations | -40, -20, -18, -16, -14, -12, -10, -8, -6, -4, -2, 0, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 30 min | Plasma glucagon concentrations |
| Plasma acetaminophen | -10, -2, 0, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 30 min | Plasma acetaminophen (as a measure of gastric emptying) |
| Plasma amino acids | -10, -2, 0, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 30 min | Plasma amino acids |
| Plasma bile acids | -10, -2, 0, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 30 min | Plasma bile acids |
| Plasma NT concentrations | -40, -20, -18, -16, -14, -12, -10, -8, -6, -4, -2, 0, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 30 min | Plasma Neurotensin concentrations |
Countries
Denmark
Contacts
Primary ContactSimon Veedfald, MD
Backup ContactJens J Holst, DMSCI
Outcome results
None listed