Epigenetics Based Diagnosis of Diabetes in Saliva and Blood Samples

NCT ID: NCT04011228

Last Updated: 2019-09-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

224 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-02-29

Study Completion Date

2020-01-01

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.

Detailed Description

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Conditions

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

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Type 2 diabetic patients

Blood sampling

Intervention Type DIAGNOSTIC_TEST

After a fasting period over night blood samples will be taken.

Saliva and blood samples

Intervention Type DIAGNOSTIC_TEST

After a fasting period over night blood and saliva samples will be taken for the investigation of epigenetics based modifications.

Magnet Resonance Spectroscopy

Intervention Type DIAGNOSTIC_TEST

The amount of ectopic lipids in the liver, heart and the skeletal muscle will be measured using 1H-magnetic resonance spectroscopy.

Prediabetic patients

Blood sampling

Intervention Type DIAGNOSTIC_TEST

After a fasting period over night blood samples will be taken.

Saliva and blood samples

Intervention Type DIAGNOSTIC_TEST

After a fasting period over night blood and saliva samples will be taken for the investigation of epigenetics based modifications.

Magnet Resonance Spectroscopy

Intervention Type DIAGNOSTIC_TEST

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

Blood sampling

Intervention Type DIAGNOSTIC_TEST

After a fasting period over night blood samples will be taken.

Saliva and blood samples

Intervention Type DIAGNOSTIC_TEST

After a fasting period over night blood and saliva samples will be taken for the investigation of epigenetics based modifications.

Magnet Resonance Spectroscopy

Intervention Type DIAGNOSTIC_TEST

The amount of ectopic lipids in the liver, heart and the skeletal muscle will be measured using 1H-magnetic resonance spectroscopy.

Healthy control subjects

Blood sampling

Intervention Type DIAGNOSTIC_TEST

After a fasting period over night blood samples will be taken.

Saliva and blood samples

Intervention Type DIAGNOSTIC_TEST

After a fasting period over night blood and saliva samples will be taken for the investigation of epigenetics based modifications.

Magnet Resonance Spectroscopy

Intervention Type DIAGNOSTIC_TEST

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

Blood sampling

Intervention Type DIAGNOSTIC_TEST

After a fasting period over night blood samples will be taken.

Saliva and blood samples

Intervention Type DIAGNOSTIC_TEST

After a fasting period over night blood and saliva samples will be taken for the investigation of epigenetics based modifications.

Magnet Resonance Spectroscopy

Intervention Type DIAGNOSTIC_TEST

The amount of ectopic lipids in the liver, heart and the skeletal muscle will be measured using 1H-magnetic resonance spectroscopy.

Interventions

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Blood sampling

After a fasting period over night blood samples will be taken.

Intervention Type 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.

Intervention Type 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.

Intervention Type DIAGNOSTIC_TEST

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Medical University of Vienna

OTHER

Sponsor Role lead

Responsible Party

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Alexandra Kautzky-Willer

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Alexandra Kautzky-Willer, Univ.Prof.Dr.

Role: PRINCIPAL_INVESTIGATOR

Department of Internal Medicine III, Clinical Division of Endocrinology and Metabolism, Unit of Gender Medicine, Medical University of Vienna

Locations

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Medical University of Vienna

Vienna, , Austria

Site Status RECRUITING

Countries

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Austria

Central Contacts

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Alexandra Kautzky-Willer, Univ.Prof.Dr.

Role: CONTACT

+434040021260

Michael Leutner, Dr.med.univ., MSc

Role: CONTACT

Facility Contacts

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Alexandra Kautzky-Willer, Univ.Prof.Dr.

Role: primary

+434040021260

References

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Klepochova R, Leutner M, Bastian M, Krebs M, Weber M, Trattnig S, Kautzky-Willer A, Krssak M. Muscle-Specific Relation of Acetylcarnitine and Intramyocellular Lipids to Chronic Hyperglycemia: A Pilot 3-T 1H MRS Study. Obesity (Silver Spring). 2020 Aug;28(8):1405-1411. doi: 10.1002/oby.22846.

Reference Type DERIVED
PMID: 32820618 (View on PubMed)

Other Identifiers

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EPI-1090

Identifier Type: -

Identifier Source: org_study_id

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