NCT03181191

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2017

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 27, 2017

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

June 6, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 8, 2017

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 3, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 3, 2017

Completed
Last Updated

September 4, 2019

Status Verified

September 1, 2019

Enrollment Period

7 months

First QC Date

June 6, 2017

Last Update Submit

September 2, 2019

Conditions

Glucose Metabolism Disorders

Outcome Measures

Primary Outcomes (1)

  • gut-derived glucagon

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

    1 year

Secondary Outcomes (1)

  • Oral glucose tolerance test

    45 minutes

Study Arms (3)

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

Oral glucose tolerance testOTHER

Oral glucose tolerance test and biopsies

Healthy control subjectsTotally pancreatectomised patientsType 2 diabetes patients

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Center for Diabetes Research

Hellerup, 2900, Denmark

Location

MeSH Terms

Conditions

Glucose Metabolism Disorders

Interventions

Glucose Tolerance Test

Condition Hierarchy (Ancestors)

Metabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Blood Chemical AnalysisClinical Chemistry TestsClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisDiagnostic Techniques, EndocrineInvestigative Techniques

Study Officials

  • Filip Knop, MD, PhD

    University Hospital, Gentofte, Copenhagen

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Consultant endocrinologist, Professor of Clinical Endocrinology and Director of Center for Clinical Metabolic Research

Study Record Dates

First Submitted

June 6, 2017

First Posted

June 8, 2017

Study Start

April 27, 2017

Primary Completion

December 3, 2017

Study Completion

December 3, 2017

Last Updated

September 4, 2019

Record last verified: 2019-09

Data Sharing

IPD Sharing
Will not share

Locations

DK(1)