CClinicalTrials.gg
CompletedNCT03181191Updated Sep 4, 2019

The Anatomical Location, Cellular Origin and Molecular Basis of Gut-derived Glucagon Secretion

An interventional study of Oral glucose tolerance test in Glucose Metabolism Disorders, sponsored by University Hospital, Gentofte, Copenhagen. Completed at 1 site in Denmark. Open to participants aged 18 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-09-04.

Sponsored by University Hospital, Gentofte, Copenhagen · Not applicable, Interventional, and Basic science

Phase
Not applicable
Study type
Interventional
Enrollment
24
Allocation
Non-randomized
Ages
18 Years to 80 Years
Sex
All
01

Study summary

Delineation of the anatomical location, cellular origin and molecular basis of gut-derived glucagon secretion

Read the detailed description

Aim: to delineate the anatomical origin, the molecular structure and precursors, the regulation and the (patho-) physiological implications of gut-derived glucagon.

Eight totally pancreatectomised patients, eight type 2 diabetes patients and eight healthy controls (age 18-80, BMI \<30) with normal kidney and liver parameters and hgb> 6.5 - will be included. The participants will each undergo one screening day and one study day including a gastroduodenoscopy. Multiple biopsies will be taken at several predefined locations in the upper gastrointestinal tract. These biopsies will be analysed with different techniques including immunohistochemical staining, quantitative polymerase chain reaction (qPCR-) analyses and more to search for glucagon. After the last biopsy has been collected, 50 g of glucose dissolved in 100 ml water is infused through the enteroscope into the most proximal part of the small intestine. Hereafter blood samples for glucagon and gut hormone analyses will be collected 15, 30 and 45 min after the glucose infusion.

02

Conditions studied

  • Glucose Metabolism Disorders
03

In context

Metabolic Diseases

997 studies on the registry are indexed under Metabolic Diseases; 234 are open to participants now.

This study's enrollment of 24 is below the median of 48 across 670 interventional studies indexed under Metabolic Diseases.

Browse Metabolic Diseases studies →

Lead sponsor

University Hospital, Gentofte, Copenhagen is the lead sponsor of 154 studies on the registry; 9 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • normal kidney function, normal liver function, normal hemoglobin levels

Exclusion criteria

Exclusion Criteria:

  • diabetes type 1, first degree relatives with type 2 diabetes
05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
24 participants (actual)

Study arms

  • Active comparator
    Totally pancreatectomised patients

    Oral glucose tolerance test and biopsies

    Other: Oral glucose tolerance test

  • Active comparator
    Type 2 diabetes patients

    Oral glucose tolerance test and biopsies

    Other: Oral glucose tolerance test

  • Active comparator
    Healthy control subjects

    Oral glucose tolerance test and biopsies

    Other: Oral glucose tolerance test

Interventions

  • OtherOral glucose tolerance test

    Oral glucose tolerance test and biopsies

06

What researchers measure

Primary outcomes

  1. gut-derived glucagon

    The primary objective is to investigate mucosal biopsies from specific regions of the upper gastrointestinal tract

    Time frame: 1 year

Secondary outcomes

  1. Oral glucose tolerance test

    Glucose metabolism - hormones, insulin, glucagon, glp-1

    Time frame: 45 minutes

07

Study locations

1 site
  • Center for Diabetes Research
    Hellerup, 2900, Denmark
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 4, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03181191
Lead sponsor
University Hospital, Gentofte, Copenhagen
Collaborators
University of Copenhagen
Responsible party
Filip Krag Knop (Consultant endocrinologist, Professor of Clinical Endocrinology and Director of Center for Clinical Metabolic Research, University Hospital, Gentofte, Copenhagen) — Principal investigator
First posted
Jun 8, 2017
Start date
Apr 27, 2017
Primary completion
Dec 3, 2017
Completion
Dec 3, 2017
Last update
Sep 4, 2019

Study contacts

Filip Knop, MD, PhD
study director · University Hospital, Gentofte, Copenhagen

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2019. You cannot join it, but the record below documents what was studied.

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