Prediabetic StateNCT04011228
Epigenetics Based Diagnosis of Diabetes in Saliva and Blood Samples
An observational study of Prediabetic State and Diabetes Mellitus, Type 2, run by Medical University of Vienna at 1 site in Austria.
Trial summary
The aim of the present study is to investigate epigenetics based modifications and biomarkers in the saliva and blood in diabetic patients. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Prediabetic State, Diabetes Mellitus, Type 2, Ectopic Lipids
- What is being tested?
- Blood sampling, Saliva and blood samples and Magnet Resonance Spectroscopy
- How many people
- 224 participants
- Where
- 1 siteAustria
- Study dates
- 29 Feb 2016to 1 Jan 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Adult, Older adult
Study population: In the present study prediabetic patients, type 2 diabetic patients, women with gestational diabetes and healthy control subjects will be included.
Who may be able to join
- type 2 diabetic patients
- prediabetic patients
- women with gestational diabetes
- healthy control subjects without diabetes
- healthy pregnant women
Who cannot join
- cancer disease
- infectious diseases such as hepatitis or HIV
- malignoms
- patients with claustrophoby
Trial locations and contacts
1 site in 1 country.
Alexandra Kautzky-Willer, Univ.Prof.Dr. contact
Michael Leutner, Dr.med.univ., MSc contact
Austria1 site, 1 recruiting
- Recruiting
Medical University of Vienna
Vienna, 1090
Alexandra Kautzky-Willer, Univ.Prof.Dr., +434040021260, alexandra.kautzky-willer@meduniwien.ac.at
About this study
Official title: 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.
- Conditions
- Prediabetic State, Diabetes Mellitus, Type 2, Ectopic Lipids, Epigenetics Based Modifications
- Being tested
- Blood sampling, Saliva and blood samples, Magnet Resonance Spectroscopy
- Medical subject headings
- Prediabetic State, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood samplingDiagnostic test
After a fasting period over night blood samples will be taken.
Saliva and blood samplesDiagnostic test
After a fasting period over night blood and saliva samples will be taken for the investigation of epigenetics based modifications.
Magnet Resonance SpectroscopyDiagnostic test
The amount of ectopic lipids in the liver, heart and the skeletal muscle will be measured using 1H-magnetic resonance spectroscopy.
| Study group | Role | What they receive |
|---|---|---|
| Type 2 diabetic patients | Not described Receives: Diagnostic Test: Blood sampling; Diagnostic Test: Saliva and blood samples; Diagnostic Test: Magnet Resonance Spectroscopy | |
| Prediabetic patients | Not described Receives: Diagnostic Test: Blood sampling; Diagnostic Test: Saliva and blood samples; Diagnostic Test: Magnet Resonance Spectroscopy | |
| Women with gestational diabetes | Not described Receives: Diagnostic Test: Blood sampling; Diagnostic Test: Saliva and blood samples; Diagnostic Test: Magnet Resonance Spectroscopy | |
| Healthy control subjects | Not described Receives: Diagnostic Test: Blood sampling; Diagnostic Test: Saliva and blood samples; Diagnostic Test: Magnet Resonance Spectroscopy | |
| Pregnant women without gestational diabetes | Not described Receives: Diagnostic Test: Blood sampling; Diagnostic Test: Saliva and blood samples; Diagnostic Test: Magnet Resonance Spectroscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 hour
Secondary outcomes (3)
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.
Measured: 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.
Measured: 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.
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2019
- Study start29 Feb 2016
- Primary completion11 Dec 2019 (estimated)
- Study completion1 Jan 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Prediabetic StateStudies of the same condition, open and under way.
- More trials run by Medical University of ViennaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 224 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alexandra Kautzky-Willer, Medical University of Vienna
- Investigators
- 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04011228
- Sponsor's protocol ID
- EPI-1090
- Status last verified
- Aug 2019
- First submitted
- 13 Mar 2019
- Last updated
- 3 Sep 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sex-specific Relationship of Epigenetics Based Modifications in the Saliva and Blood With the Occurence of Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT04011228
- Acronym / sponsor ID
- EPI-1090
- Conditions
- Prediabetic State, Diabetes Mellitus, Type 2, Ectopic Lipids, Epigenetics Based Modifications
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 224 participants (estimated)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Study start
- 29 Feb 2016 (actual)
- Primary completion
- 11 Dec 2019 (estimated)
- Study completion
- 1 Jan 2020 (estimated)
- First posted
- 8 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of the present study is to investigate epigenetics based modifications and biomarkers in the saliva and blood in diabetic patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- In the present study prediabetic patients, type 2 diabetic patients, women with gestational diabetes and healthy control subjects will be included.
Key inclusion criteria (5 listed)
- type 2 diabetic patients
- prediabetic patients
- women with gestational diabetes
- healthy control subjects without diabetes
- healthy pregnant women
Key exclusion criteria (4 listed)
- cancer disease
- infectious diseases such as hepatitis or HIV
- malignoms
- patients with claustrophoby
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood samplingAfter a fasting period over night blood samples will be taken. | Diagnostic test | Healthy control subjects, Prediabetic patients, Pregnant women without gestational diabetes, Type 2 diabetic patients, Women with gestational diabetes |
| Saliva and blood samplesAfter a fasting period over night blood and saliva samples will be taken for the investigation of epigenetics based modifications. | Diagnostic test | Healthy control subjects, Prediabetic patients, Pregnant women without gestational diabetes, Type 2 diabetic patients, Women with gestational diabetes |
| Magnet Resonance SpectroscopyThe amount of ectopic lipids in the liver, heart and the skeletal muscle will be measured using 1H-magnetic resonance spectroscopy. | Diagnostic test | Healthy control subjects, Prediabetic patients, Pregnant women without gestational diabetes, Type 2 diabetic patients, Women with gestational diabetes |
Primary outcome
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.
3 secondary outcomes
Correlation of the percentage of liver fat with miRNA´s in diabetic patients.
Time frame: 1 hours
Correlation of the percentage of heart fat with miRNA´s in diabetic patients
Time frame: 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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2019.
- Derived from this study: PubMed 32820618Klepochova 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alexandra Kautzky-Willer, Univ.Prof.Dr. contact
Michael Leutner, Dr.med.univ., MSc contact
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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Prediabetic State and Diabetes Mellitus, Type 2, run by Medical University of Vienna at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Alexandra Kautzky-Willer, Univ.Prof.Dr. (+434040021260, alexandra.kautzky-willer@meduniwien.ac.at), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Specifying the microRNAs in saliva in diabetic patients (time frame: 1 hour). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04011228, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Sep 2019.