The Anatomical Location, Cellular Origin and Molecular Ba... | NCT03181191

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

NCT03181191

Sponsor

University Hospital, Gentofte, Copenhagen

Status

Completed

Last Update Posted

Sep 4, 2019Actual

Enrollment

24Actual

Phase

Not Applicable

Conditions

Glucose Metabolism Disorders

Interventions

Oral glucose tolerance test

Countries

Denmark

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2019

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 27, 2017Actual

Primary Completion Date

Dec 3, 2017Actual

Completion Date

Dec 3, 2017Actual

First Submitted Date

Jun 6, 2017

First Submission Date that Met QC Criteria

Jun 6, 2017

First Posted Date

Jun 8, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 2, 2019

Last Update Posted Date

Sep 4, 2019Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Filip Krag Knop, Consultant endocrinologist, Professor of Clinical Endocrinology and Director of Center for Clinical Metabolic Research, University Hospital, Gentofte, CopenhagenPrincipal Investigator

Lead Sponsor

University Hospital, Gentofte, CopenhagenOTHER

Collaborators

Name	Class
University of Copenhagen	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

24Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Totally pancreatectomised patients	Active Comparator	Oral glucose tolerance test and biopsies	Other: Oral glucose tolerance test
Type 2 diabetes patients	Active Comparator	Oral glucose tolerance test and biopsies	Other: Oral glucose tolerance test
Healthy control subjects	Active Comparator	Oral glucose tolerance test and biopsies	Other: Oral glucose tolerance test

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Oral glucose tolerance test	Other	Oral glucose tolerance test and biopsies	Healthy control subjects Totally pancreatectomised patients Type 2 diabetes patients

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Filip Knop, MD, PhD	University Hospital, Gentofte, Copenhagen	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Center for Diabetes Research		Hellerup		2900	Denmark

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D044882	Glucose Metabolism Disorders

Ancestor Terms

ID	Term
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D005951	Glucose Tolerance Test

Ancestor Terms

ID	Term
D001774	Blood Chemical Analysis
D019963	Clinical Chemistry Tests
D019411	Clinical Laboratory Techniques
D019937	Diagnostic Techniques and Procedures

Browse Leaves

Not provided

Browse Branches

Not provided