Polycystic Ovary SyndromeNCT03204461
Glucose Metabolism in Different PCOS Phenotypes
An observational study of Polycystic Ovary Syndrome and Glucose Intolerance, run by Medical University of Vienna at 1 site in Austria.
Trial summary
In the present study glucose metabolism and ectopic lipids in the liver, heart and muscle were investigated in women with the polycystic ovary syndrome (PCOS) and in healthy control subjects. Read more about this study
- Who is it for?
- Ages 20 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Polycystic Ovary Syndrome, Glucose Intolerance, Liver Fat
- What is being tested?
- Oral glucose tolerance test (OGTT) and 1H-magnetic resonance spectroscopy
- Type of treatment
- Pill or oral medicine
- How many people
- 73 participants
- Where
- 1 siteAustria
- Study dates
- 3 Dec 2012to 30 Jul 2015
- 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 20 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: In the present study women with the Polycystic Ovary Syndrome, defined according to the NIH-criteria and the Rotterdam criteria were included. The control Group consisted of healthy volunteers without a diagnosis of prediabetes, Diabetes or the PCOS.
Who may be able to join
- Women with the polycystic ovary Syndrome defined according to the Rotterdam and the NIH-criteria
- healthy control subjects
Who cannot join
- BMI>=40kg/m²
- Diagnosis of Diabetes in the PCOS-Group
- Diagnosis of Prediabetes or Diabetes in the control group
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Associatons of PCOS Phenotypes With Ectopic Lipids, Adipocytokines and Parameters of Insulin Resistance
In the present study glucose metabolism and ectopic lipids in the liver, heart and muscle were investigated in women with the polycystic ovary syndrome (PCOS) and in healthy control subjects.
Read the detailed description
In detail an oral glucose tolerance test (OGTT) was conducted in women with the PCOS defined by the Rotterdam and the NIH-criteria, as well as in healthy control subjects. In addition 1H-magnetic resonance spectroscopy and Imaging was used for the assessment of the ectopic lipid content in the liver, heart and skeletal muscle. The aim of the present study was to compare the glucose metabolism and the ectopic lipid conent in the liver, heart and muscle between women with the PCOS defined by the NIH-criteria, Rotterdam-criteria and healthy control subjects.
- Being tested
- Oral glucose tolerance test (OGTT), 1H-magnetic resonance spectroscopy
- Medical subject headings
- Polycystic Ovary Syndrome, Glucose Intolerance, Fatty Liver, Glucose Metabolism Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral glucose tolerance test (OGTT)Diagnostic test
For the assessment of glucose metabolism, including beta-cell function and insulin sensitivity an 75g-OGTT was conducted.
1H-magnetic resonance spectroscopyOther
The amount of ectopic lipids in the liver, heart and the skeletal muscle was measured using 1H-magnetic resonance spectroscopy.
| Study group | Role | What they receive |
|---|---|---|
| PCOS-NIH | Not described Receives: Diagnostic Test: Oral glucose tolerance test (OGTT); Other: 1H-magnetic resonance spectroscopy | |
| PCOS-Rotterdam | Not described Receives: Diagnostic Test: Oral glucose tolerance test (OGTT); Other: 1H-magnetic resonance spectroscopy | |
| Controls | Not described Receives: Diagnostic Test: Oral glucose tolerance test (OGTT); Other: 1H-magnetic resonance spectroscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of glucose metabolism between PCOS women and healthy control subjects, using data of the OGTT.
In the present study the Glucose metabolism in PCOS women and control subjects was assessed with an OGTT. Therefore the dynamic levels of glucose, insulin and C-peptide were assessed during an extended OGTT for the calculation of Insulin resistance and beta-cell function. In addition an 1H-magnetic resonance spectroscopy was done for the assessment of the ectopic lipid content in the liver, heart and the skeletal muscle.
Measured: Up to 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2017
- Study start3 Dec 2012
- Primary completion9 Jul 2015
- Study completion30 Jul 2015
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 Polycystic Ovary SyndromeStudies 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
- Other
- Time perspective
- Prospective
- Enrolment
- 73 participants (actual)
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
- NCT03204461
- Sponsor's protocol ID
- PCOS-1090
- Status last verified
- Jun 2017
- First submitted
- 26 Jun 2017
- Last updated
- 2 Jul 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Leutner M, Gobl C, Wolf P, Maruszczak K, Bozkurt L, Steinbrecher H, Just-Kukurova I, Ott J, Egarter C, Trattnig S, Kautzky-Willer A. Pericardial Fat Relates to Disturbances of Glucose Metabolism in Women with the Polycystic Ovary Syndrome, but Not in Healthy Control Subjects. Int J Endocrinol. 2018 Aug 7;2018:5406128. doi: 10.1155/2018/5406128. eCollection 2018.
PubMed 30158974
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Associatons of PCOS Phenotypes With Ectopic Lipids, Adipocytokines and Parameters of Insulin Resistance
- ClinicalTrials.gov ID
- NCT03204461
- Acronym / sponsor ID
- PCOS-1090
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 73 participants (actual)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Study start
- 3 Dec 2012 (actual)
- Primary completion
- 9 Jul 2015 (actual)
- Study completion
- 30 Jul 2015 (actual)
- First posted
- 2 Jul 2017 (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.
In the present study glucose metabolism and ectopic lipids in the liver, heart and muscle were investigated in women with the polycystic ovary syndrome (PCOS) and in healthy control subjects.
Detailed description
In detail an oral glucose tolerance test (OGTT) was conducted in women with the PCOS defined by the Rotterdam and the NIH-criteria, as well as in healthy control subjects. In addition 1H-magnetic resonance spectroscopy and Imaging was used for the assessment of the ectopic lipid content in the liver, heart and skeletal muscle. The aim of the present study was to compare the glucose metabolism and the ectopic lipid conent in the liver, heart and muscle between women with the PCOS defined by the NIH-criteria, Rotterdam-criteria and healthy control subjects.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| PCOS-NIH | – | Diagnostic Test: Oral glucose tolerance test (OGTT), Other: 1H-magnetic resonance spectroscopy |
| PCOS-Rotterdam | – | Diagnostic Test: Oral glucose tolerance test (OGTT), Other: 1H-magnetic resonance spectroscopy |
| Controls | – | Diagnostic Test: Oral glucose tolerance test (OGTT), Other: 1H-magnetic resonance spectroscopy |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- In the present study women with the Polycystic Ovary Syndrome, defined according to the NIH-criteria and the Rotterdam criteria were included. The control Group consisted of healthy volunteers without a diagnosis of prediabetes, Diabetes or the PCOS.
Key inclusion criteria (2 listed)
- Women with the polycystic ovary Syndrome defined according to the Rotterdam and the NIH-criteria
- healthy control subjects
Key exclusion criteria (3 listed)
- BMI>=40kg/m²
- Diagnosis of Diabetes in the PCOS-Group
- Diagnosis of Prediabetes or Diabetes in the control group
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 |
|---|---|---|
| Oral glucose tolerance test (OGTT)For the assessment of glucose metabolism, including beta-cell function and insulin sensitivity an 75g-OGTT was conducted. | Diagnostic test | Controls, PCOS-NIH, PCOS-Rotterdam |
| 1H-magnetic resonance spectroscopyThe amount of ectopic lipids in the liver, heart and the skeletal muscle was measured using 1H-magnetic resonance spectroscopy. | Other | Controls, PCOS-NIH, PCOS-Rotterdam |
Primary outcome
Comparison of glucose metabolism between PCOS women and healthy control subjects, using data of the OGTT.
Time frame: Up to 4 weeks
In the present study the Glucose metabolism in PCOS women and control subjects was assessed with an OGTT. Therefore the dynamic levels of glucose, insulin and C-peptide were assessed during an extended OGTT for the calculation of Insulin resistance and beta-cell function. In addition an 1H-magnetic resonance spectroscopy was done for the assessment of the ectopic lipid content in the liver, heart and the skeletal muscle.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2017.
- Derived from this study: PubMed 30158974Leutner M, Gobl C, Wolf P, Maruszczak K, Bozkurt L, Steinbrecher H, Just-Kukurova I, Ott J, Egarter C, Trattnig S, Kautzky-Willer A. Pericardial Fat Relates to Disturbances of Glucose Metabolism in Women with the Polycystic Ovary Syndrome, but Not in Healthy Control Subjects. Int J Endocrinol. 2018 Aug 7;2018:5406128. doi: 10.1155/2018/5406128. eCollection 2018.
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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. 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 Polycystic Ovary Syndrome and Glucose Intolerance, 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 2 inclusion and 3 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: finished, as of the sponsor's last update on 2 Jul 2017. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of glucose metabolism between PCOS women and healthy control subjects, using data of the OGTT. (time frame: Up to 4 weeks). 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 NCT03204461, 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 2 Jul 2017.