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Completed

NCT Number: NCT03181191

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

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

Completed

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Center for Diabetes Research

Hellerup, 2900, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Oral glucose tolerance test

Other

Oral glucose tolerance test and biopsies

Primary outcomes

  1. gut-derived glucagon

    Time frame: 1 year

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

Secondary outcomes

  1. Oral glucose tolerance test

    Time frame: 45 minutes

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

Sponsors and collaborators

Lead sponsor

University Hospital, Gentofte, Copenhagen

Other

Collaborators

  • University of Copenhagen

Registry information

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Jun 8, 2017
Registry last updated
Sep 4, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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