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CTRI Number  CTRI/2019/01/017119 [Registered on: 17/01/2019] Trial Registered Prospectively
Last Modified On: 11/01/2019
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Study on prediction of risk for Diabetes during pregnancy  
Scientific Title of Study   Study on Gestational Diabetes Mellitus for risk prediction using Mass spectroscopy based proteomics and metabolomics. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  K Neelaveni 
Designation  Professor (Endocrinology) 
Affiliation  Osmania Medical College 
Address  Department of Endocrinology. Osmania Medical College Osmania General Hospital, Afzalgunj,Hyderabad -500012 Telangana, India

Hyderabad
TELANGANA
500012
India 
Phone  9848131182  
Fax    
Email  neelaveni1@yahoo.co.in  
 
Details of Contact Person
Scientific Query
 
Name  K Neelaveni 
Designation  Professor (Endocrinology) 
Affiliation  Osmania Medical College 
Address  Department of Endocrinology. Osmania Medical College Osmania General Hospital, Afzalgunj,Hyderabad -500012 Telangana, India

Hyderabad
TELANGANA
500012
India 
Phone  9848131182  
Fax    
Email  neelaveni1@yahoo.co.in  
 
Details of Contact Person
Public Query
 
Name  K Neelaveni 
Designation  Professor (Endocrinology) 
Affiliation  Osmania Medical College 
Address  Department of Endocrinology. Osmania Medical College Osmania General Hospital, Afzalgunj,Hyderabad -500012 Telangana, India

Hyderabad
TELANGANA
500012
India 
Phone  9848131182  
Fax    
Email  neelaveni1@yahoo.co.in  
 
Source of Monetary or Material Support  
Osmania Medical College Afzalgunj,Hyderabad -500012 Telangana, India 
 
Primary Sponsor  
Name  Osmania Medical College 
Address  Afzalgunj,Hyderabad -500012 Telangana, India  
Type of Sponsor  Government medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr K Neelaveni  Osmania Medical College  Department of Endocrinology. Osmania Medical College Osmania General Hospital, Afzalgunj,Hyderabad -500012 Telangana, India
Hyderabad
TELANGANA 
9848131182

neelaveni1@yahoo.co.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institute Ethics committee,   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O244||Gestational diabetes mellitus,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  40.00 Year(s)
Gender  Female 
Details  1PCOS women non pregnant and pregnant PCOS women with GDM
2.non PCOS GDM
3.healthy controls pregnant and non pregnant.
 
 
ExclusionCriteria 
Details  Pregestational diabetes
Patients not willing to participate in the study
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To search for biomarkers for predicting the risk of Gestational Diabetes Mellitus early .  At the time of recruitment of participants 
 
Secondary Outcome  
Outcome  TimePoints 
• 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

• Proteomics Biomarker: Protein

• Validation of biomarker of GDM using Western blot and qPCR
 
At the time of recruitment of participants 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   23/01/2019 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   None yet 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

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. 

 
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