NCT04011228

Brief Summary

The aim of the present study is to investigate epigenetics based modifications and biomarkers in the saliva and blood in diabetic patients.

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
224

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2016

Longer than P75 for all trials

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

February 29, 2016

Completed
3 years until next milestone

First Submitted

Initial submission to the registry

March 13, 2019

Completed
4 months until next milestone

First Posted

Study publicly available on registry

July 8, 2019

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 11, 2019

Completed
21 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2020

Completed
Last Updated

September 3, 2019

Status Verified

August 1, 2019

Enrollment Period

3.8 years

First QC Date

March 13, 2019

Last Update Submit

August 29, 2019

Conditions

Prediabetic StateDiabetes Mellitus, Type 2Ectopic LipidsEpigenetics Based Modifications

Outcome Measures

Primary Outcomes (1)

  • Specifying the microRNAs in saliva in diabetic patients

    Characterization of microRNAs in saliva of prediabetic and type 2 diabetic patients, as well as in women with gestational diabetes and healthy control subjects.

    1 hour

Secondary Outcomes (3)

  • Correlation of the percentage of liver fat with miRNA´s in diabetic patients.

    1 hours

  • Correlation of the percentage of heart fat with miRNA´s in diabetic patients

    1 hour

  • Correlation of the percentage of the content of fat in the skeletal muscle with miRNA´s in diabetic patients.

    1 hour

Study Arms (5)

Type 2 diabetic patients

Diagnostic Test: Blood samplingDiagnostic Test: Saliva and blood samplesDiagnostic Test: Magnet Resonance Spectroscopy

Prediabetic patients

Diagnostic Test: Blood samplingDiagnostic Test: Saliva and blood samplesDiagnostic Test: Magnet Resonance Spectroscopy

Women with gestational diabetes

Diagnostic Test: Blood samplingDiagnostic Test: Saliva and blood samplesDiagnostic Test: Magnet Resonance Spectroscopy

Healthy control subjects

Diagnostic Test: Blood samplingDiagnostic Test: Saliva and blood samplesDiagnostic Test: Magnet Resonance Spectroscopy

Pregnant women without gestational diabetes

Diagnostic Test: Blood samplingDiagnostic Test: Saliva and blood samplesDiagnostic Test: Magnet Resonance Spectroscopy

Interventions

Blood samplingDIAGNOSTIC_TEST

After a fasting period over night blood samples will be taken.

Healthy control subjectsPrediabetic patientsPregnant women without gestational diabetesType 2 diabetic patientsWomen with gestational diabetes
Saliva and blood samplesDIAGNOSTIC_TEST

After a fasting period over night blood and saliva samples will be taken for the investigation of epigenetics based modifications.

Healthy control subjectsPrediabetic patientsPregnant women without gestational diabetesType 2 diabetic patientsWomen with gestational diabetes
Magnet Resonance SpectroscopyDIAGNOSTIC_TEST

The amount of ectopic lipids in the liver, heart and the skeletal muscle will be measured using 1H-magnetic resonance spectroscopy.

Healthy control subjectsPrediabetic patientsPregnant women without gestational diabetesType 2 diabetic patientsWomen with gestational diabetes

Eligibility Criteria

Age18 Years - 75 Years
Sexall(Gender-based eligibility)
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

In the present study prediabetic patients, type 2 diabetic patients, women with gestational diabetes and healthy control subjects will be included.

You may qualify if:

  • type 2 diabetic patients
  • prediabetic patients
  • women with gestational diabetes
  • healthy control subjects without diabetes
  • healthy pregnant women

You may not qualify if:

  • cancer disease
  • infectious diseases such as hepatitis or HIV
  • malignoms
  • patients with claustrophoby

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical University of Vienna

Vienna, 1090, Austria

RECRUITING

Related Publications (1)

  • Klepochova R, Leutner M, Bastian M, Krebs M, Weber M, Trattnig S, Kautzky-Willer A, Krssak M. Muscle-Specific Relation of Acetylcarnitine and Intramyocellular Lipids to Chronic Hyperglycemia: A Pilot 3-T 1H MRS Study. Obesity (Silver Spring). 2020 Aug;28(8):1405-1411. doi: 10.1002/oby.22846.

    PMID: 32820618DERIVED

MeSH Terms

Conditions

Prediabetic StateDiabetes Mellitus, Type 2

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

Study Officials

  • Alexandra Kautzky-Willer, Univ.Prof.Dr.

    Department of Internal Medicine III, Clinical Division of Endocrinology and Metabolism, Unit of Gender Medicine, Medical University of Vienna

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Alexandra Kautzky-Willer, Univ.Prof.Dr.

CONTACT

+434040021260alexandra.kautzky-willer@meduniwien.ac.at

Michael Leutner, Dr.med.univ., MSc

CONTACT

michael.leutner@meduniwien.ac.at

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 13, 2019

First Posted

July 8, 2019

Study Start

February 29, 2016

Primary Completion

December 11, 2019

Study Completion

January 1, 2020

Last Updated

September 3, 2019

Record last verified: 2019-08

Locations

AU(1)