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Clinical Trials/CTRI/2019/01/017119
CTRI/2019/01/017119Not yet recruitingNot Applicable

Study on Gestational Diabetes Mellitus for risk prediction using Mass spectroscopy based proteomics and metabolomics.

Osmania Medical College1 site in 1 country30 target enrollmentStarted: January 23, 2019Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Not yet recruiting
Enrollment
30
Locations
1
Primary Endpoint
To search for biomarkers for predicting the risk of Gestational Diabetes Mellitus early .

Study Overview

Brief Summary

Gestational diabetes mellitus (GDM) is a common medical  complication of pregnancy affecting  approximately 5-15% of all pregnancies globally with a rapidly increasing incidence, mainly attributed to advanced maternal age, type 2 diabetes mellitus (T2DM) in pregnant women and the rising prevalence of obesity . Asians are ethnically more prone to develop GDM. GDM is defined as varying severity of hyperglycemia with the onset or first recognition during gestation and is characterized by insulin resistance as well as decreased  β- cell function . GDM is associated with short-term adverse maternal and neonatal outcomes. Not only Women with GDM,even their offspring are also at increased risk of developing type 2 diabetes, cardiovascular diseases and obesity later in life .

Following the recommendations of the World Health Organization and the International Association of Diabetes and Pregnancy Study Groups, diagnosis of GDM is performed with the use of the oral glucose tolerance test (OGTT) in the second trimester of pregnancy, between 24-28 weeks of gestation, allowing limited time for successful intervention. Earlier screening however, ideally in the first trimester of pregnancy when women are enrolled in prenatal care, has the potential to either improve pregnancy outcomes through lifestyle changes and pharmacological interventions or even reduce the frequency of the disease and the severity of the associated maternal and perinatal complications.

Historically, first trimester prenatal screening for GDM has been performed based on the presence of clinical risk factors, including maternal age, parity, race/ethnicity, body mass index (BMI), family history of diabetes and history of GDM in a previous pregnancy. These factors have also been incorporated into multivariate logistic regression models, similar to those used for fetal aneuploidy screening. These methods however, are poor predictors of pregnant women who will develop GDM and are mainly used to identify who should be offered the OGTT to diagnose GDM.

IdentLficatLon of novel biomarkers for the detection of women destined to develop GDM in early pregnancy, with the potential to either improve the predictive value of current prenatal screening or replace the available methodology is a major goal for researchers in the field of maternal-fetal medicine.

proteomics studies have clearly demonstrate that biomarkers already exist in maternal circulation at 11-13 weeks of gestation in women who subsequently will develop GDM and have the potential to increase the pool of biomarker candidates. Since currently available candidate proteomic biomarkers have been LdentLfied through small in size case control studies, well-designed large scale proteomic studies, following the guidelines of clinical proteomics, are needed to verify these results and possibly discover novel ones for the early detection of women at risk for GDM . These biomarkers may improve early prenatal screening for GDM, further elucidate the mechanisms involved in the pathogenesis of the disease and facilitate the evaluation of early therapeutic interventions for ameliorating short and long term adverse outcomes for the mother and newborn.

PCOS is the most common endocrinopathy affecting the women in their reproductive age.Insulin resistance plays an important role in the pathogenesis of PCOS.  PCOS women are at higher risk of developing GDM than others.

It will be interesting to see the progression and connection between Polcystic ovary syndrome (PCOS) and Gestational diabetes mellitus (GDM). It would be interesting to study theproteomic and metabolomic profile the baby aswell from GDM mother and PCOS-GDM Mother.

Study Design

Study Type
Observational

Eligibility Criteria

Ages
18.00 Year(s) to 40.00 Year(s) (—)
Sex
Female

Inclusion Criteria

  • •1PCOS women non pregnant and pregnant PCOS women with GDM 2.non PCOS GDM 3.healthy controls pregnant and non pregnant.

Exclusion Criteria

  • •Pregestational diabetes Patients not willing to participate in the study.

Outcomes

Primary Outcomes

To search for biomarkers for predicting the risk of Gestational Diabetes Mellitus early .

Time Frame: At the time of recruitment of participants

Secondary Outcomes

  • •Establishment of Biomarker for diagnostic / early diagnostic of GDM and PCOS using body fluids especially serum/plasma, and saliva, by the help of high resolution mass spectrometry and quantitative proteomics and metabolomics.(•Metabolomics biomarker: small molecules, amino acid, carbohydrate, lipid and peptide)

Investigators

Sponsor Class
Government medical college

Study Sites (1)

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