Studies of the Early Meal Phase in Healthy Individuals - Nutrient Absorption and Gastrointestinal Hormone Secretion
- Conditions
- Healthy
- Interventions
- Other: Oral glucose tolerance testOther: Liquid mixed meal test
- Registration Number
- NCT03543423
- Lead Sponsor
- University of Copenhagen
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- Male
- Target Recruitment
- 12
- Age between 18 and 40years
- Male
- Normal Haemoglobin concentration
- Informed consent
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Oral glucose tolerance test Oral glucose tolerance test Intervention: oral glucose tolerance test (75 gram glucose supplemented with 5g 3-OMG and 1g paracetamol) ingested over 2 min. Liquid mixed meal test Liquid mixed meal test Intervention: Standardised liquid mixed meal (supplemented with 1g paracetamol) ingested over 2min
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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 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
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
Serum 3-OMG 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 (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 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 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
Trial Locations
- Locations (1)
Department of Gastrointestinal Surgery, Righospitalet
🇩🇰Copenhagen, Capital, Denmark