Clinical trial NCT03543423: Studies of the Early Meal Phase in Healthy Individuals - Nutrient Absorption and Gastrointestinal Hormone Secretion
Official title: Studier af Den Tidlige Måltidsfase i Raske Individer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Healthy
Keywords: Gut hormone secretion
Glucose absorption
early meal phase
Insulin and glucagon secretion
Lead sponsor: University of Copenhagen
Sponsor class: OTHER
Collaborators: name: Rigshospitalet, Denmark
First posted: 2018-06-01
Enrollment: 12
Sex: MALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
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
Primary purpose: BASIC_SCIENCE

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.


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

Primary outcomes:
measure: Plasma GIP concentrations
timeFrame: -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 outcomes:
measure: Plasma GLP-1 concentrations
timeFrame: -40, -20, -18, -16, -14, -12, -10, -8, -6, -4, -2, 0, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 30 min
measure: Serum 3-OMG concentrations
timeFrame: -10, -2, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 30
measure: Serum C-peptide and insulin concentrations
timeFrame: -40, -20, -18, -16, -14, -12, -10, -8, -6, -4, -2, 0, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 30 min
measure: Plasma gastrin concentrations
timeFrame: -40, -20, -18, -16, -14, -12, -10, -8, -6, -4, -2, 0, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 30 min
measure: Plasma CCK concentrations
timeFrame: -40, -20, -18, -16, -14, -12, -10, -8, -6, -4, -2, 0, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 30 min
measure: Plasma PP concentrations
timeFrame: -40, -20, -18, -16, -14, -12, -10, -8, -6, -4, -2, 0, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 30 min
measure: Plasma NT concentrations
timeFrame: -40, -20, -18, -16, -14, -12, -10, -8, -6, -4, -2, 0, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 30 min
measure: Plasma glucagon concentrations
timeFrame: -40, -20, -18, -16, -14, -12, -10, -8, -6, -4, -2, 0, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 30 min
measure: Serum 3-OMG concentrations
timeFrame: -40, -20, -18, -16, -14, -12, -10, -8, -6, -4, -2, 0, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 30 min
measure: Plasma acetaminophen
timeFrame: -10, -2, 0, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 30 min
measure: Plasma amino acids
timeFrame: -10, -2, 0, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 30 min
measure: Plasma bile acids
timeFrame: -10, -2, 0, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 30 min
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Department of Gastrointestinal Surgery, Righospitalet
state: Capital
Study officials:
affiliation: Department of Biomedical Sciences
name: Jens J Holst, DMSCI
role: PRINCIPAL_INVESTIGATOR
References:
citation: Veedfald S, Rehfeld JF, van Hall G, Svendsen LB, Holst JJ. Entero-Pancreatic Hormone Secretion, Gastric Emptying, and Glucose Absorption After Frequently Sampled Meal Tests. J Clin Endocrinol Metab. 2022 Jan 1;107(1):e188-e204. doi: 10.1210/clinem/dgab610.