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NCT03181191 Clinical Trial

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

Glucose Metabolism Disorders Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03181191
Other study ID # UHG-CFD-PX-BIOPSY
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date April 27, 2017
Est. completion date December 3, 2017

Study information
Verified date September 2019
Source University Hospital, Gentofte, Copenhagen
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility
Status Completed
Enrollment 24
Est. completion date December 3, 2017
Est. primary completion date December 3, 2017
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 80 Years
Eligibility Inclusion Criteria:

- normal kidney function, normal liver function, normal hemoglobin levels

Exclusion Criteria:

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

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• Oral glucose tolerance test
Oral glucose tolerance test and biopsies

Locations
Country Name City State
Denmark Center for Diabetes Research Hellerup

Sponsors (2)
Lead Sponsor Collaborator
University Hospital, Gentofte, Copenhagen University of Copenhagen

Country where clinical trial is conducted

Denmark, 

Outcome
Type Measure Description Time frame Safety issue
Primary gut-derived glucagon The primary objective is to investigate mucosal biopsies from specific regions of the upper gastrointestinal tract 1 year
Secondary Oral glucose tolerance test Glucose metabolism - hormones, insulin, glucagon, glp-1 45 minutes
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