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

Studier af Den Tidlige Måltidsfase i Raske Individer

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.

Study Overview

• Status: Unknown
• Conditions: Healthy
• Intervention / Treatment: Other: Oral glucose tolerance test; Other: Liquid mixed meal test

• Study Type: Interventional
• Enrollment (Anticipated): 12
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Capital
    • Copenhagen, Capital, Denmark, 2100
      • Recruiting
      • Department of Gastrointestinal Surgery, Righospitalet
      • Contact: Lars Bo Svendsen, DMSci; Email: lars.bo.svendsen@regionh.dk
      • Contact: Simon Veedfald, MD; Phone Number: +4541102595; Email: Simon.veedfald@regionh.dk
      • Principal Investigator: Simon Veedfald, MD
      • Principal Investigator: Jens J Holst, DMsci
      • Principal Investigator: Lars Bo Svendsen

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Oral glucose tolerance test; 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; 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
Experimental: Liquid mixed meal test; Intervention: Standardised liquid mixed meal (supplemented with 1g paracetamol) ingested over 2min	Other: 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).

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

Collaborators and Investigators

• Sponsor: University of Copenhagen
• Collaborators: Rigshospitalet, Denmark
• Investigators: Principal Investigator: Jens J Holst, DMSCI, Department of Biomedical Sciences

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Anticipated): June 1, 2018
• Primary Completion (Anticipated): September 30, 2018
• Study Completion (Anticipated): June 30, 2019

Study Registration Dates

• First Submitted: May 20, 2018
• First Submitted That Met QC Criteria: May 20, 2018
• First Posted (Actual): June 1, 2018

Study Record Updates

• Last Update Posted (Actual): June 1, 2018
• Last Update Submitted That Met QC Criteria: May 20, 2018
• Last Verified: May 1, 2018

More Information

Terms related to this study

• Keywords: Glucose absorption; Gut hormone secretion; early meal phase; Insulin and glucagon secretion
• Other Study ID Numbers: UC/RH-early phase

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No