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

Healthy Clinical Trial

Official title:

Studier af Den Tidlige Måltidsfase i Raske Individer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03543423
• Other study ID #: UC/RH-early phase
• Status: Recruiting
• Phase: N/A
• Start date: June 1, 2018
• Est. completion date: June 30, 2019

Study information

• Verified date: May 2018
• Source: University of Copenhagen
• Contact: Simon Veedfald, MD
• Phone: +45 41102595
• Email: veedfald[@]sund.ku.dk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 12
• Est. completion date: June 30, 2019
• Est. primary completion date: September 30, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy

Intervention

Other:
• Oral 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
• Liquid mixed meal test
A standardised liquid mixed meal test will be carried out using a standard liquid mixed meal (fresubin drink supplemented with 1g paracetamol).

Locations

Country	Name	City	State
Denmark	Department of Gastrointestinal Surgery, Righospitalet	Copenhagen	Capital

Sponsors (2)

Lead Sponsor	Collaborator
University of Copenhagen	Rigshospitalet, Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Serum 3-OMG concentrations	Serum 3-OMG concentrations (glucose absorption marker)	-10, -2, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 30
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Plasma amino acids	Plasma amino acids	-10, -2, 0, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 30 min
Secondary	Plasma bile acids	Plasma bile acids	-10, -2, 0, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 30 min