Gestational Diabetes MellitusNCT02378675
Adipocytokines, Gestational Diabetes Mellitus and Lipid Metabolism
An observational study of Gestational Diabetes Mellitus, run by Medical University of Vienna at 1 site in Austria.
Trial summary
Apelin, Visfatin, Omentin and Resistin are adipocytokines derived from human adipose tissue as well as placental tissue and have been shown to be potential mediators of insulin resistance. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Gestational Diabetes Mellitus
- What is being tested?
- Blood draw
- How many people
- 300 participants
- Where
- 1 siteAustria
- Study dates
- Aug 2012to Dec 2013
- 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 50 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: 150 pregnant women with diagnosed gestational diabetes mellitus (Study group) and 150 pregnant women with normal oral glucose tolerance test (OGTT).
Who may be able to join
- Age above 18 years
- Informed consent
- Diagnosed gestational diabetes mellitus
Who cannot join
- Preexisting diabetes mellitus
- Any kind of immunodeficiency
- HIV, HCV, HBV
- Immunomodulating drugs (IF-Gamma, etc.)
- Cancer, chronic diseases
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Influence of the Adipocytokines Apelin, Omentin, Resistin and Visfatin on Lipid Metabolism and Gestational Diabetes Mellitus
Apelin, Visfatin, Omentin and Resistin are adipocytokines derived from human adipose tissue as well as placental tissue and have been shown to be potential mediators of insulin resistance. In each pregnancy, a physiological Insulin resistance syndrome occurs to ensure that the fetus is sufficiently supplied with glucose. Due to their impact on glucose transport mechanisms adipocytokines play an important role for the development of insulin resistance.
Gestational diabetes mellitus (GDM) is one of the most common pregnancy - associated diseases with a prevalence of 5-10% of all pregnancies and its prevalence is increasing. It is associated with severe hazards to both mother and fetus such as macrosomia, plexus palsy, premature delivery and intrauterine death. Furthermore, up to 50% of women with GDM develop Type 2 Diabetes Mellitus (DM2) within the following ten years after pregnancy. GDM seems to be a potent risk factor for the development of DM2 in later life by sharing a number of epidemiological, physiological and genetic characteristics with DM2. Therefore, alterations in adipocytokine levels in women with GDM, if present, may resemble those observed with DM2.
Read more
Furthermore, the exact pathogenesis of GDM is not completely understood, however, increased insulin resistance is a well demonstrated mechanism.
Adipocytokines are known to alter insulin resistance through several mechanisms described in the literature. The investigators therefore expect a possible relationship between the above described adipocytokines and gestational diabetes mellitus.
Results of the HAPO-Study have shown a significant association between fetal outcome and mean blood glucose levels in women suffering from GDM. The HAPO Study group supposed a possible relationship between GDM and fetal insulin levels and used C-Peptide to quantify fetal hyperinsulinemia.
A recent study suggests that not only hyperglycemia but also altered maternal lipid metabolism may constitute a risk factor for macrosomia in GDM.
In summary, the investigators aim to illuminate a possible association between the adipocytokines Apelin, Omentin, Resistin and Visfatin, lipid metabolism and gestational diabetes mellitus.
- Conditions
- Gestational Diabetes Mellitus
- Being tested
- Blood draw
- Keywords
- Adipocytokines
- Medical subject headings
- Diabetes, Gestational
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood drawOther
During the routine blood sampling, a 10ml plasma sample as well as a 10ml serum sample will be obtained, spinned and stored at -80°C until the final assessment of adipocytokines.
| Study group | Role | What they receive |
|---|---|---|
| Healthy (1) | Adipocytokine levels of patients suffering from GDM are compared to healthy pregnant women Receives: Other: Blood draw | |
| GDM (2) | Adipocytokine levels of patients suffering from GDM are compared to healthy pregnant women Receives: Other: Blood draw |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference of adipocytokines between women with GDM and women with normal glucose tolerance.
Measured: 02/2015
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2015 (estimated)
- Study startAug 2012
- Primary completionDec 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gestational Diabetes MellitusStudies 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
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Katharina Worda, Medical University of Vienna
- Investigators
- Katharina Worda, Priv.Doz., Principal investigator, Medical University of Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02378675
- Sponsor's protocol ID
- 11072
- Status last verified
- Feb 2015
- First submitted
- 27 Feb 2015
- Last updated
- 4 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of the Adipocytokines Apelin, Omentin, Resistin and Visfatin on Lipid Metabolism and Gestational Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT02378675
- Acronym / sponsor ID
- 11072
- Conditions
- Gestational Diabetes Mellitus
- Keywords
- Adipocytokines
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Study start
- Aug 2012
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 4 Mar 2015 (estimated)
- 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.
Apelin, Visfatin, Omentin and Resistin are adipocytokines derived from human adipose tissue as well as placental tissue and have been shown to be potential mediators of insulin resistance. In each pregnancy, a physiological Insulin resistance syndrome occurs to ensure that the fetus is sufficiently supplied with glucose. Due to their impact on glucose transport mechanisms adipocytokines play an important role for the development of insulin resistance.
Gestational diabetes mellitus (GDM) is one of the most common pregnancy - associated diseases with a prevalence of 5-10% of all pregnancies and its prevalence is increasing. It is associated with severe hazards to both mother and fetus such as macrosomia, plexus palsy, premature delivery and intrauterine death. Furthermore, up to 50% of women with GDM develop Type 2 Diabetes Mellitus (DM2) within the following ten years after pregnancy. GDM seems to be a potent risk factor for the development of DM2 in later life by sharing a number of epidemiological, physiological and genetic characteristics with DM2. Therefore, alterations in adipocytokine levels in women with GDM, if present, may resemble those observed with DM2.
Furthermore, the exact pathogenesis of GDM is not completely understood, however, increased insulin resistance is a well demonstrated mechanism.
Adipocytokines are known to alter insulin resistance through several mechanisms described in the literature. The investigators therefore expect a possible relationship between the above described adipocytokines and gestational diabetes mellitus.
Results of the HAPO-Study have shown a significant association between fetal outcome and mean blood glucose levels in women suffering from GDM. The HAPO Study group supposed a possible relationship between GDM and fetal insulin levels and used C-Peptide to quantify fetal hyperinsulinemia.
A recent study suggests that not only hyperglycemia but also altered maternal lipid metabolism may constitute a risk factor for macrosomia in GDM.
In summary, the investigators aim to illuminate a possible association between the adipocytokines Apelin, Omentin, Resistin and Visfatin, lipid metabolism and gestational diabetes mellitus.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healthy (1) | – | Other: Blood drawAdipocytokine levels of patients suffering from GDM are compared to healthy pregnant women |
| GDM (2) | – | Other: Blood drawAdipocytokine levels of patients suffering from GDM are compared to healthy pregnant women |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- 150 pregnant women with diagnosed gestational diabetes mellitus (Study group) and 150 pregnant women with normal oral glucose tolerance test (OGTT).
Key inclusion criteria (3 listed)
- Age above 18 years
- Informed consent
- Diagnosed gestational diabetes mellitus
Key exclusion criteria (5 listed)
- Preexisting diabetes mellitus
- Any kind of immunodeficiency
- HIV, HCV, HBV
- Immunomodulating drugs (IF-Gamma, etc.)
- Cancer, chronic diseases
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 drawDuring the routine blood sampling, a 10ml plasma sample as well as a 10ml serum sample will be obtained, spinned and stored at -80°C until the final assessment of adipocytokines. | Other | GDM (2), Healthy (1) |
Primary outcome
Difference of adipocytokines between women with GDM and women with normal glucose tolerance.
Time frame: 02/2015
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 4 Mar 2015.
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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.
Katharina Worda, Priv.Doz. principal investigator
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 Gestational Diabetes Mellitus, 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 3 inclusion and 5 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 4 Mar 2015. 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?
Difference of adipocytokines between women with GDM and women with normal glucose tolerance. (time frame: 02/2015). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 Mar 2015.