Epigenetics Based Diagnosis of Diabetes in Saliva and Blood Samples

• Conditions: Ectopic Lipids; Prediabetic State; Diabetes Mellitus, Type 2; Epigenetics Based Modifications

• Registration Number: NCT04011228
• Lead Sponsor: Medical University of Vienna

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2016-02-29
• Study First Submitted: 2019-03-13
• Study First Submitted QC: 2019-07-05
• Study First Posted: 2019-07-08
• Status Verified: 2019-08
• Last Update Submitted: 2019-08-29
• Last Update Posted: 2019-09-03
• Primary Completion: 2019-12-11
• Study Completion: 2020-01-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 224

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Specifying the microRNAs in saliva in diabetic patients	1 hour	Characterization of microRNAs in saliva of prediabetic and type 2 diabetic patients, as well as in women with gestational diabetes and healthy control subjects.

Secondary Outcome Measures

Name	Time	Method
Correlation of the percentage of the content of fat in the skeletal muscle with miRNA´s in diabetic patients.	1 hour	Correlation of miRNA´s in the saliva with the amount of ectopic lipids in the skeletal muscle.
Correlation of the percentage of liver fat with miRNA´s in diabetic patients.	1 hours	Correlation of miRNA´s in the saliva with the amount of intrahepatic liver fat.
Correlation of the percentage of heart fat with miRNA´s in diabetic patients	1 hour	Correlation of miRNA´s in the saliva with the amount of ectopic lipids in the heart.

Trial Locations

Locations (1)

Medical University of Vienna; 🇦🇹 Vienna, Austria