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Status unknownNCT04011228Updated Sep 3, 2019

Epigenetics Based Diagnosis of Diabetes in Saliva and Blood Samples

An observational study in Prediabetic State, Diabetes Mellitus, Type 2 and Ectopic Lipids, sponsored by Medical University of Vienna. Status unknown at 1 site in Austria. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2019-09-03.

Sponsored by Medical University of Vienna · Observational

The sponsor has not verified this record recently (last verified Aug 2019), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
224
Ages
18 Years to 75 Years
Sex
All
01

Study summary

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

02

Conditions studied

  • Prediabetic State
  • Diabetes Mellitus, Type 2
  • Ectopic Lipids
  • Epigenetics Based Modifications
03

In context

Diabetes Mellitus

10,923 studies on the registry are indexed under Diabetes Mellitus; 1,318 are open to participants now.

This study's planned enrollment of 224 is close to the median of 233 across 2,218 observational studies indexed under Diabetes Mellitus.

Browse Diabetes Mellitus studies →

Lead sponsor

Medical University of Vienna is the lead sponsor of 1,076 studies on the registry; 177 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
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.

Inclusion criteria

  • type 2 diabetic patients
  • prediabetic patients
  • women with gestational diabetes
  • healthy control subjects without diabetes
  • healthy pregnant women

Exclusion criteria

Exclusion Criteria:

  • cancer disease
  • infectious diseases such as hepatitis or HIV
  • malignoms
  • patients with claustrophoby
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
224 participants (estimated)
Patient registry
No

Groups and cohorts

  • Type 2 diabetic patients

    Diagnostic Test: Blood sampling · Diagnostic Test: Saliva and blood samples · Diagnostic Test: Magnet Resonance Spectroscopy

  • Prediabetic patients

    Diagnostic Test: Blood sampling · Diagnostic Test: Saliva and blood samples · Diagnostic Test: Magnet Resonance Spectroscopy

  • Women with gestational diabetes

    Diagnostic Test: Blood sampling · Diagnostic Test: Saliva and blood samples · Diagnostic Test: Magnet Resonance Spectroscopy

  • Healthy control subjects

    Diagnostic Test: Blood sampling · Diagnostic Test: Saliva and blood samples · Diagnostic Test: Magnet Resonance Spectroscopy

  • Pregnant women without gestational diabetes

    Diagnostic Test: Blood sampling · Diagnostic Test: Saliva and blood samples · Diagnostic Test: Magnet Resonance Spectroscopy

Interventions

  • Diagnostic testBlood sampling

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

  • Diagnostic testSaliva and blood samples

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

  • Diagnostic testMagnet Resonance Spectroscopy

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

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 1 hour

Secondary outcomes

  1. 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.

    Time frame: 1 hours

  2. 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.

    Time frame: 1 hour

  3. 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.

    Time frame: 1 hour

07

Study locations

1 of 1 sites recruiting
08

References and documents

Publications

  • 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. PubMed 32820618 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 3, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04011228
Lead sponsor
Medical University of Vienna
Responsible party
Alexandra Kautzky-Willer (Principal Investigator, Medical University of Vienna) — Principal investigator
First posted
Jul 8, 2019
Start date
Feb 29, 2016
Primary completion
Dec 11, 2019 (estimated)
Completion
Jan 1, 2020 (estimated)
Last update
Sep 3, 2019

Study contacts

Alexandra Kautzky-Willer, Univ.Prof.Dr.
Contact
alexandra.kautzky-willer@meduniwien.ac.at
+434040021260
Michael Leutner, Dr.med.univ., MSc
Contact
michael.leutner@meduniwien.ac.at
Alexandra Kautzky-Willer, Univ.Prof.Dr.
principal investigator · Department of Internal Medicine III, Clinical Division of Endocrinology and Metabolism, Unit of Gender Medicine, Medical University of Vienna

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is status unknown, as verified in Aug 2019. You cannot join it, but the record below documents what was studied.

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