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NCT04011228 Clinical Trial

Epigenetics Based Diagnosis of Diabetes in Saliva and Blood Samples

Diabetes Mellitus, Type 2 Clinical Trial

Official title:
Sex-specific Relationship of Epigenetics Based Modifications in the Saliva and Blood With the Occurence of Type 2 Diabetes

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT04011228
Other study ID # EPI-1090
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date February 29, 2016
Est. completion date January 1, 2020

Study information
Verified date August 2019
Source Medical University of Vienna
Contact Alexandra Kautzky-Willer, Univ.Prof.Dr.
Phone +434040021260
Email alexandra.kautzky-willer@meduniwien.ac.at
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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

Recruitment information / eligibility
Status Recruiting
Enrollment 224
Est. completion date January 1, 2020
Est. primary completion date December 11, 2019
Accepts healthy volunteers
Gender All
Age group 18 Years to 75 Years
Eligibility Inclusion Criteria:

- type 2 diabetic patients

- prediabetic patients

- women with gestational diabetes

- healthy control subjects without diabetes

- healthy pregnant women

Exclusion Criteria:

- cancer disease

- infectious diseases such as hepatitis or HIV

- malignoms

- patients with claustrophoby

Study Design

Related Conditions & MeSH terms

Intervention

Diagnostic Test:
• Blood sampling
After a fasting period over night blood samples will be taken.
• Saliva and blood samples
After a fasting period over night blood and saliva samples will be taken for the investigation of epigenetics based modifications.
• Magnet Resonance Spectroscopy
The amount of ectopic lipids in the liver, heart and the skeletal muscle will be measured using 1H-magnetic resonance spectroscopy.

Locations
Country Name City State
Austria Medical University of Vienna Vienna

Sponsors (1)
Lead Sponsor Collaborator
Medical University of Vienna

Country where clinical trial is conducted

Austria, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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 Correlation of the percentage of liver fat with miRNA´s in diabetic patients. Correlation of miRNA´s in the saliva with the amount of intrahepatic liver fat. 1 hours
Secondary Correlation of the percentage of heart fat with miRNA´s in diabetic patients Correlation of miRNA´s in the saliva with the amount of ectopic lipids in the heart. 1 hour
Secondary Correlation of the percentage of the content of fat in the skeletal muscle with miRNA´s in diabetic patients. Correlation of miRNA´s in the saliva with the amount of ectopic lipids in the skeletal muscle. 1 hour
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