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Epigenetics Based Diagnosis of Diabetes in Saliva and Blood Samples

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ClinicalTrials.gov Identifier: NCT04011228
Recruitment Status : Recruiting
First Posted : July 8, 2019
Last Update Posted : September 3, 2019
Sponsor:
Information provided by (Responsible Party):
Alexandra Kautzky-Willer, 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.

Condition or disease Intervention/treatment
Prediabetic State Diabetes Mellitus, Type 2 Ectopic Lipids Epigenetics Based Modifications Diagnostic Test: Blood sampling Diagnostic Test: Saliva and blood samples Diagnostic Test: Magnet Resonance Spectroscopy

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Study Type : Observational
Estimated Enrollment : 224 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Sex-specific Relationship of Epigenetics Based Modifications in the Saliva and Blood With the Occurence of Type 2 Diabetes
Actual Study Start Date : February 29, 2016
Estimated Primary Completion Date : December 11, 2019
Estimated Study Completion Date : January 1, 2020

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
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.

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.

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.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Gender Based Eligibility:   Yes
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.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04011228


Contacts
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Contact: Alexandra Kautzky-Willer, Univ.Prof.Dr. +434040021260 alexandra.kautzky-willer@meduniwien.ac.at
Contact: Michael Leutner, Dr.med.univ., MSc michael.leutner@meduniwien.ac.at

Locations
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Austria
Medical University of Vienna Recruiting
Vienna, Austria, 1090
Contact: Alexandra Kautzky-Willer, Univ.Prof.Dr.    +434040021260    alexandra.kautzky-willer@meduniwien.ac.at   
Sponsors and Collaborators
Medical University of Vienna
Investigators
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Principal Investigator: 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
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Responsible Party: Alexandra Kautzky-Willer, Principal Investigator, Medical University of Vienna
ClinicalTrials.gov Identifier: NCT04011228    
Other Study ID Numbers: EPI-1090
First Posted: July 8, 2019    Key Record Dates
Last Update Posted: September 3, 2019
Last Verified: August 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Prediabetic State
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases