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

Primary Purpose

Glucose Metabolism Disorders

Status

Completed

Phase

Not Applicable

Locations

Denmark

Study Type

Interventional

Intervention

Oral glucose tolerance test

About this trial

This is an interventional basic science trial for Glucose Metabolism Disorders

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

normal kidney function, normal liver function, normal hemoglobin levels

Exclusion Criteria:

diabetes type 1, first degree relatives with type 2 diabetes

Sites / Locations

Center for Diabetes Research

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Arm Label

Totally pancreatectomised patients

Type 2 diabetes patients

Healthy control subjects

Arm Description

Oral glucose tolerance test and biopsies

Outcomes

Primary Outcome Measures

gut-derived glucagon

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

Secondary Outcome Measures

Oral glucose tolerance test

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

Full Information

NCT ID

NCT03181191

First Posted

June 6, 2017

Last Updated

September 2, 2019

Sponsor

University Hospital, Gentofte, Copenhagen

Collaborators

University of Copenhagen

1. Study Identification

Unique Protocol Identification Number

NCT03181191

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2019

Overall Recruitment Status

Completed

Study Start Date

April 27, 2017 (Actual)

Primary Completion Date

December 3, 2017 (Actual)

Study Completion Date

December 3, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University Hospital, Gentofte, Copenhagen

Collaborators

University of Copenhagen

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Glucose Metabolism Disorders

7. Study Design

Primary Purpose

Basic Science

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

24 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Totally pancreatectomised patients

Arm Type

Active Comparator

Arm Description

Oral glucose tolerance test and biopsies

Arm Title

Type 2 diabetes patients

Arm Type

Active Comparator

Arm Description

Oral glucose tolerance test and biopsies

Arm Title

Healthy control subjects

Arm Type

Active Comparator

Arm Description

Oral glucose tolerance test and biopsies

Intervention Type

Other

Intervention Name(s)

Oral glucose tolerance test

Intervention Description

Oral glucose tolerance test and biopsies

Primary Outcome Measure Information:

Title

gut-derived glucagon

Description

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

Time Frame

1 year

Secondary Outcome Measure Information:

Title

Oral glucose tolerance test

Description

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

Time Frame

45 minutes

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: normal kidney function, normal liver function, normal hemoglobin levels Exclusion Criteria: diabetes type 1, first degree relatives with type 2 diabetes

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Filip Knop, MD, PhD

Organizational Affiliation

University Hospital, Gentofte, Copenhagen

Official's Role

Study Director

Facility Information:

Facility Name

Center for Diabetes Research

City

Hellerup

ZIP/Postal Code

2900

Country

Denmark

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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