Epigenetics Based Diagnosis of Diabetes in Saliva and Blood Samples

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

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

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

Intervention / Treatment
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* Diagnostic Test: Blood sampling
* Diagnostic Test: Saliva and blood samples
* Diagnostic Test: Magnet Resonance Spectroscopy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Type 2 diabetic patients<br> | Diagnostic Test: Blood sampling<br>* After a fasting period over night blood samples will be taken.<br>Diagnostic Test: Saliva and blood samples<br>* After a fasting period over night blood and saliva samples will be taken for the investigation of epigenetics based modifications.<br>Diagnostic Test: Magnet Resonance Spectroscopy<br>* The amount of ectopic lipids in the liver, heart and the skeletal muscle will be measured using 1H-magnetic resonance spectroscopy.<br>|
| Prediabetic patients<br> | Diagnostic Test: Blood sampling<br>* After a fasting period over night blood samples will be taken.<br>Diagnostic Test: Saliva and blood samples<br>* After a fasting period over night blood and saliva samples will be taken for the investigation of epigenetics based modifications.<br>Diagnostic Test: Magnet Resonance Spectroscopy<br>* The amount of ectopic lipids in the liver, heart and the skeletal muscle will be measured using 1H-magnetic resonance spectroscopy.<br>|
| Women with gestational diabetes<br> | Diagnostic Test: Blood sampling<br>* After a fasting period over night blood samples will be taken.<br>Diagnostic Test: Saliva and blood samples<br>* After a fasting period over night blood and saliva samples will be taken for the investigation of epigenetics based modifications.<br>Diagnostic Test: Magnet Resonance Spectroscopy<br>* The amount of ectopic lipids in the liver, heart and the skeletal muscle will be measured using 1H-magnetic resonance spectroscopy.<br>|
| Healthy control subjects<br> | Diagnostic Test: Blood sampling<br>* After a fasting period over night blood samples will be taken.<br>Diagnostic Test: Saliva and blood samples<br>* After a fasting period over night blood and saliva samples will be taken for the investigation of epigenetics based modifications.<br>Diagnostic Test: Magnet Resonance Spectroscopy<br>* The amount of ectopic lipids in the liver, heart and the skeletal muscle will be measured using 1H-magnetic resonance spectroscopy.<br>|
| Pregnant women without gestational diabetes<br> | Diagnostic Test: Blood sampling<br>* After a fasting period over night blood samples will be taken.<br>Diagnostic Test: Saliva and blood samples<br>* After a fasting period over night blood and saliva samples will be taken for the investigation of epigenetics based modifications.<br>Diagnostic Test: Magnet Resonance Spectroscopy<br>* The amount of ectopic lipids in the liver, heart and the skeletal muscle will be measured using 1H-magnetic resonance spectroscopy.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 |