NCT04474535

Brief Summary

The purpose of this study is to investigate the presence of residual insulin secretion in patients with DM1 and its correlation with the possible protection against early microvascular and macrovascular complications, emphasizing on the functionality of the myocardium.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2020

Geographic Reach
1 country

1 active site

Status
unknown

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

March 3, 2020

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

July 13, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 17, 2020

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2021

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2021

Completed
Last Updated

July 17, 2020

Status Verified

July 1, 2020

Enrollment Period

1.4 years

First QC Date

July 13, 2020

Last Update Submit

July 13, 2020

Conditions

Type 1 DiabetesC-peptideDiabetes Complications

Outcome Measures

Primary Outcomes (3)

  • C-peptide concentrations

    Concentrations of plasma c-peptide in the fasting condition

    1 day

  • Microvascular complications

    Presence of microvascular complications

    1 day

  • Macrovascular complications

    Presence of macrovascular complications

    1 day

Secondary Outcomes (1)

  • Association between c-peptide and complications

    1 day

Eligibility Criteria

Age15 Years - 70 Years
Sexall
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Consecutive patients with type 1 diabetes followed in our Diabetes outpatient clinic

You may qualify if:

  • Type 1 diabetes
  • Informed consent form

You may not qualify if:

  • Known macrovascular complications
  • Known serious microvascular complications

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Diabetes Clinical Research Laboratory, 1st Department of Propaedeutic Internal Medicine

Athens, 11527, Greece

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum, plasma, urine

MeSH Terms

Conditions

Diabetes Mellitus, Type 1Diabetes Complications

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Alexandros Kokkinos

    First Department of Propaedeutic Medicine, University of Athens

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Alexandros Kokkinos

CONTACT

+302132061248rjd@otenet.gr

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor in Internal Medicine

Study Record Dates

First Submitted

July 13, 2020

First Posted

July 17, 2020

Study Start

March 3, 2020

Primary Completion

August 1, 2021

Study Completion

December 1, 2021

Last Updated

July 17, 2020

Record last verified: 2020-07

Locations

GR(1)