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Clinical Trials/NCT03543423
NCT03543423UnknownNot Applicable

Studier af Den Tidlige Måltidsfase i Raske Individer

University of Copenhagen2 sites in 1 country12 target enrollmentStarted: June 1, 2018Last updated:
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Conditions

Trial Snapshot

Phase
Not Applicable
Enrollment
12
Locations
2
Primary Endpoint
Plasma GIP concentrations
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

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.

Study Design

Study Type
Interventional
Allocation
Non Randomized
Intervention Model
Single Group
Primary Purpose
Basic Science
Masking
None

Eligibility Criteria

Ages
18 Years to 40 Years (Adult)
Sex
Male
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • •Age between 18 and 40years
  • •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

Outcomes

Primary Outcomes

Plasma GIP concentrations

Time Frame: -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 Outcomes

  • Plasma bile acids(-10, -2, 0, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 30 min)
  • 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 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)
  • 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 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)
  • 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(-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(-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(-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(-10, -2, 0, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 30 min)
  • Plasma amino acids(-10, -2, 0, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 30 min)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Simon Veedfald

Post doc

University of Copenhagen

Study Sites (2)

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