Studies of the Early Meal Phase in Healthy Individuals - Nutrient Absorption and Gastrointestinal Hormone Secretion

Study Overview
=================
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.

Official Title
-----------------
Studier af Den Tidlige Måltidsfase i Raske Individer

Conditions
-----------------
Healthy

Intervention / Treatment
-----------------
* Other: Oral glucose tolerance test
* Other: Liquid mixed meal test


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
-----------------
Male

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Basic Science
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Interventional Model Description: 12 healthy male individuals will each be studied on two occasions in random order. oral glucose tolerance test liquid mixed meal test
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Oral glucose tolerance test<br>Intervention: oral glucose tolerance test (75 gram glucose supplemented with 5g 3-OMG and 1g paracetamol) ingested over 2 min. | Other: Oral glucose tolerance test<br>* 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<br>|
| Experimental: Liquid mixed meal test<br>Intervention: Standardised liquid mixed meal (supplemented with 1g paracetamol) ingested over 2min | Other: Liquid mixed meal test<br>* A standardised liquid mixed meal test will be carried out using a standard liquid mixed meal (fresubin drink supplemented with 1g paracetamol).<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plasma GIP concentrations | Glucose-dependent insulinotropic polypeptide plasma 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plasma GLP-1 concentrations | Glucagon-like peptide-1 plasma 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 | 
| Serum 3-OMG concentrations | Serum 3-OMG concentrations (glucose absorption marker) | -10, -2, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 30 | 
| Serum C-peptide and insulin concentrations | Glucagon-like peptide-1 plasma 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 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 CCK concentrations | Plasma cholecystokinin 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 PP concentrations | Plasma pancreatic polypeptide 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 NT concentrations | Plasma Neurotensin 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 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 | 
| Serum 3-OMG concentrations | Serum 3-OMG concentrations (glucose absorption marker) | -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 acetaminophen | Plasma acetaminophen (as a measure of gastric emptying) | -10, -2, 0, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 30 min | 
| Plasma amino acids | Plasma amino acids | -10, -2, 0, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 30 min | 
| Plasma bile acids | Plasma bile acids | -10, -2, 0, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 30 min | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Gut hormone secretion, Glucose absorption, early meal phase, Insulin and glucagon secretion