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

September 2, 2019 updated by: Filip Krag Knop, University Hospital, Gentofte, Copenhagen
Delineation of the anatomical location, cellular origin and molecular basis of gut-derived glucagon secretion

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

24

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Hellerup, Denmark, 2900
        • Center for diabetes research

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Totally pancreatectomised patients
Oral glucose tolerance test and biopsies
Other: Oral glucose tolerance test
Oral glucose tolerance test and biopsies
Active Comparator: Type 2 diabetes patients
Oral glucose tolerance test and biopsies
Other: Oral glucose tolerance test
Oral glucose tolerance test and biopsies
Active Comparator: Healthy control subjects
Oral glucose tolerance test and biopsies
Other: Oral glucose tolerance test
Oral glucose tolerance test and biopsies

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
gut-derived glucagon
Time Frame: 1 year
The primary objective is to investigate mucosal biopsies from specific regions of the upper gastrointestinal tract
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Oral glucose tolerance test
Time Frame: 45 minutes
Glucose metabolism - hormones, insulin, glucagon, glp-1
45 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Gentofte, Copenhagen

Collaborators

University of Copenhagen

Investigators

  • Study Director: Filip Knop, MD, PhD, University Hospital, Gentofte, Copenhagen

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 27, 2017

Primary Completion (Actual)

December 3, 2017

Study Completion (Actual)

December 3, 2017

Study Registration Dates

First Submitted

June 6, 2017

First Submitted That Met QC Criteria

June 6, 2017

First Posted (Actual)

June 8, 2017

Study Record Updates

Last Update Posted (Actual)

September 4, 2019

Last Update Submitted That Met QC Criteria

September 2, 2019

Last Verified

September 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UHG-CFD-PX-BIOPSY

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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