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
|
|
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
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
(1) ICD-10 Condition: O244||Gestational diabetes mellitus, |
|
Intervention / Comparator Agent
|
|
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. |