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CompletedNCT02378675Updated Mar 4, 2015

Adipocytokines, Gestational Diabetes Mellitus and Lipid Metabolism

An observational study in Gestational Diabetes Mellitus, sponsored by Medical University of Vienna. Completed at 1 site in Austria. Open to female participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2015-03-04.

Sponsored by Medical University of Vienna · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
300
Ages
18 Years to 50 Years
Sex
Female
01

Study 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. 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.

02

Conditions studied

  • Gestational Diabetes Mellitus

Keywords

  • Adipocytokines
03

In context

Diabetes, Gestational

842 studies on the registry are indexed under Diabetes, Gestational; 198 are open to participants now.

This study's enrollment of 300 is above the median of 200 across 269 observational studies indexed under Diabetes, Gestational.

Browse Diabetes, Gestational 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 50 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

150 pregnant women with diagnosed gestational diabetes mellitus (Study group) and 150 pregnant women with normal oral glucose tolerance test (OGTT).

Inclusion criteria

  • Age above 18 years
  • Informed consent
  • Diagnosed gestational diabetes mellitus

Exclusion criteria

Exclusion Criteria:

  • Preexisting diabetes mellitus
  • Any kind of immunodeficiency
  • HIV, HCV, HBV
  • Immunomodulating drugs (IF-Gamma, etc.)
  • Cancer, chronic diseases
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
300 participants (actual)
Patient registry
No
Biospecimen retention
Samples with dna

Groups and cohorts

  • Healthy (1)

    Adipocytokine levels of patients suffering from GDM are compared to healthy pregnant women

    Other: Blood draw

  • GDM (2)

    Adipocytokine levels of patients suffering from GDM are compared to healthy pregnant women

    Other: Blood draw

Interventions

  • OtherBlood draw

    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.

06

What researchers measure

Primary outcomes

  1. Difference of adipocytokines between women with GDM and women with normal glucose tolerance.

    Time frame: 02/2015

07

Study locations

1 site
  • Medical University of Vienna
    Vienna, 1090, Austria
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 4, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02378675
Lead sponsor
Medical University of Vienna
Responsible party
Dr. Katharina Worda (Priv. Doz. Dr. Katharina Worda, Medical University of Vienna) — Principal investigator
First posted
Mar 4, 2015
Start date
Aug 2012
Primary completion
Dec 2013
Completion
Dec 2013
Last update
Mar 4, 2015

Study contacts

Katharina Worda, Priv.Doz.
principal investigator · Medical University of Vienna

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2015. You cannot join it, but the record below documents what was studied.

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