Study on prediction of risk for Diabetes during pregnancy

Not yet recruiting

Conditions: Gestational diabetes mellitus,

Registration Number: CTRI/2019/01/017119

Lead Sponsor: Osmania Medical College

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 Î²- 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.**

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Yet Recruiting

Sex: Female

Target Recruitment: 30

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.

Study & Design

Study Type: Observational

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To search for biomarkers for predicting the risk of Gestational Diabetes Mellitus early .	At the time of recruitment of participants

Secondary Outcome Measures

Name	Time	Method
â€¢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.	â€¢Metabolomics biomarker: small molecules, amino acid, carbohydrate, lipid and peptide

Trial Locations

Locations (1): Osmania Medical College
🇮🇳
Hyderabad, TELANGANA, India
Osmania Medical College
🇮🇳Hyderabad, TELANGANA, India
Dr K Neelaveni
Principal investigator
9848131182
neelaveni1@yahoo.co.in