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

NCT ID: NCT03181191

Last Updated: 2019-09-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-04-27

Study Completion Date

2017-12-03

Brief Summary

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

Detailed Description

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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.

Conditions

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Glucose Metabolism Disorders

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Totally pancreatectomised patients

Oral glucose tolerance test and biopsies

Group Type ACTIVE_COMPARATOR

Oral glucose tolerance test

Intervention Type OTHER

Oral glucose tolerance test and biopsies

Type 2 diabetes patients

Oral glucose tolerance test and biopsies

Group Type ACTIVE_COMPARATOR

Oral glucose tolerance test

Intervention Type OTHER

Oral glucose tolerance test and biopsies

Healthy control subjects

Oral glucose tolerance test and biopsies

Group Type ACTIVE_COMPARATOR

Oral glucose tolerance test

Intervention Type OTHER

Oral glucose tolerance test and biopsies

Interventions

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Oral glucose tolerance test

Oral glucose tolerance test and biopsies

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* normal kidney function, normal liver function, normal hemoglobin levels

Exclusion Criteria

* diabetes type 1, first degree relatives with type 2 diabetes
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Copenhagen

OTHER

Sponsor Role collaborator

University Hospital, Gentofte, Copenhagen

OTHER

Sponsor Role lead

Responsible Party

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Filip Krag Knop

Consultant endocrinologist, Professor of Clinical Endocrinology and Director of Center for Clinical Metabolic Research

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Filip Knop, MD, PhD

Role: STUDY_DIRECTOR

University Hospital, Gentofte, Copenhagen

Locations

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Center for Diabetes Research

Hellerup, , Denmark

Site Status

Countries

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Denmark

Other Identifiers

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UHG-CFD-PX-BIOPSY

Identifier Type: -

Identifier Source: org_study_id

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