Adipocytokines, Gestational Diabetes Mellitus and Lipid Metabolism

Completed

• Conditions: Gestational Diabetes Mellitus
• Interventions: Other: Blood draw

• Registration Number: NCT02378675
• Lead Sponsor: Medical University of Vienna

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-08
• Primary Completion: 2013-12
• Study Completion: 2013-12
• Status Verified: 2015-02
• Study First Submitted: 2015-02-27
• Study First Submitted QC: 2015-03-03
• Last Update Submitted: 2015-03-03
• Study First Posted: 2015-03-04
• Last Update Posted: 2015-03-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 300

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Healthy (1)	Blood draw	Adipocytokine levels of patients suffering from GDM are compared to healthy pregnant women
GDM (2)	Blood draw	Adipocytokine levels of patients suffering from GDM are compared to healthy pregnant women

Primary Outcome Measures

Name	Time	Method
Difference of adipocytokines between women with GDM and women with normal glucose tolerance.	02/2015

Trial Locations

Locations (1)

Medical University of Vienna; 🇦🇹 Vienna, Austria