Epigenetics Based Diagnosis of Diabetes in Saliva and Blood Samples

August 29, 2019 updated by: Alexandra Kautzky-Willer, Medical University of Vienna

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

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

224

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Specifying the microRNAs in saliva in diabetic patients
Time Frame: 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.
1 hour

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Correlation of the percentage of liver fat with miRNA´s in diabetic patients.
Time Frame: 1 hours
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
Time Frame: 1 hour
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.
Time Frame: 1 hour
Correlation of miRNA´s in the saliva with the amount of ectopic lipids in the skeletal muscle.
1 hour

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical University of Vienna

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 29, 2016

Primary Completion (Anticipated)

December 11, 2019

Study Completion (Anticipated)

January 1, 2020

Study Registration Dates

First Submitted

March 13, 2019

First Submitted That Met QC Criteria

July 5, 2019

First Posted (Actual)

July 8, 2019

Study Record Updates

Last Update Posted (Actual)

September 3, 2019

Last Update Submitted That Met QC Criteria

August 29, 2019

Last Verified

August 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EPI-1090

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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