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CTRI Number  CTRI/2025/03/082905 [Registered on: 20/03/2025] Trial Registered Prospectively
Last Modified On: 18/03/2025
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   A study to rule out thyroid hormone status (index) and their association with risk of developing gestaional diabetes mellitus  
Scientific Title of Study   Thyroid hormone indices as biomarkers for risk of gestational diabetes  
Trial Acronym  Nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Manju Jha 
Designation  Assistant Professor 
Affiliation  RUHS COLLEGE OF MEDICAL SCIENCES 
Address  Department of Biochemistry, RUHS College of Medical Sciences, Jaipur, Rajasthan, India.

Jaipur
RAJASTHAN
302033
India 
Phone  9001063619  
Fax    
Email  drmanjujha77@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Manju Jha 
Designation  Assistant Professor 
Affiliation  RUHS COLLEGE OF MEDICAL SCIENCES 
Address  Department of Biochemistry, RUHS College of Medical Sciences, Jaipur, Rajasthan, India.

Jaipur
RAJASTHAN
302033
India 
Phone  9001063619  
Fax    
Email  drmanjujha77@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Manju Jha 
Designation  Assistant Professor 
Affiliation  RUHS COLLEGE OF MEDICAL SCIENCES 
Address  Department of Biochemistry, RUHS College of Medical Sciences, Jaipur, Rajasthan, India.

Jaipur
RAJASTHAN
302033
India 
Phone  9001063619  
Fax    
Email  drmanjujha77@gmail.com  
 
Source of Monetary or Material Support  
Multidisciplinary Research Unit, RUHS College of Medical Sciences, Jaipur, Rajasthan, India. PIN-302033 
 
Primary Sponsor  
Name  Department of Health Research 
Address  Multidisciplinary Research Unit, Govt of India.  
Type of Sponsor  Government funding agency 
 
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 Manju Jha  RUHS College of Medical Sciences, Jaipur, Rajasthan, India  Department of Obstetrics and Gynecology, RDBP Jaipuria Hospital, Milap Nagar, and Hospital of RUHS College of Medical Sciences, Jaipur, Rajasthan, India. PIN-302033.
Jaipur
RAJASTHAN 
9001063619

drmanjujha77@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Ethics Committee of RUHS College of Medical Sciences  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, (2) ICD-10 Condition: O281||Abnormal biochemical finding on antenatal screening of mother,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  NIL  NIL 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  45.00 Year(s)
Gender  Female 
Details  Pregnant women who had normal thyroid function and glucose levels in early pregnancy before conception.
Who have completed normal OGTT (2 hour, 75g) in early pregnancy.
Singleton pregnancy.
 
 
ExclusionCriteria 
Details  a. Pregnant women with pre-existing diabetes (type 1 or 2) or thyroid disorders diagnosed during the first pre-natal examination.
b. Pregnant women with cardiovascular, cerebrovascular, respiratory disease, or systemic illness related to kidneys/liver.
c. Women undergoing medication treatment for diabetes or thyroid function before or during the first trimester or steroid treatment.
d. Personal or family history of thyroid disease
e. Visible/palpable goitre
f. History of autoimmune disease
g. Multiple pregnancy
h. Polycystic ovary syndrome
i. Missing thyroid or diabetes related basic data of early pregnancy
 
 
Method of Generating Random Sequence    
Method of Concealment    
Blinding/Masking    
Primary Outcome  
Outcome  TimePoints 
To investigate the relationship between central thyroid hormone sensitivity and periph eral thyroid hormone sensitivity in euthyroid females with the subsequent risk of GDM   3rd trimester 
 
Secondary Outcome  
Outcome  TimePoints 
2. To examine trimester-specific associations of thyroid sensitivity status and GDM  3 months 
 
Target Sample Size   Total Sample Size="400"
Sample Size from India="400" 
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)   01/04/2025 
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   N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

A plethora of studies have evidenced the relation of Hypothyroidism with Diabetes Mellitus.  Talking about the prevalence of hypothyroidism in India it is about 3.9%, with higher prevalence in women at 11.4% compared to men at 6.2%. Pregnancy impacts thyroid function as the hormone production increase in gestation by 50%. About 10%–15% of pregnant women have thyroid disorders during pregnancy including subclinical hyper- or hypothyroidism and by routine screening correction of these disorders can be done which will eventually reduce the risk of adverse feto-maternal outcomes like foetal loss, preterm birth etc. Gestational diabetes mellitus is the most prevalent disease among pregnant women affecting 4-14% of population in India. Recently the association between thyroid insensitivity and reduced response to the thyroid hormones is considered to be a risk factor for diabetes in general and also during pregnancy.

The purpose of this study is to explore the association of central and peripheral thyroid resistance indices with the risk of Gestational Diabetes Mellitus (GDM). The relation between gestational diabetes and thyroid disorders with the help of thyroid indices has been a less explored arena.

The study will be hospital based prospective cross-sectional study and participants will be pregnant females (18-45years) In this study we will analyse all the routine biochemical parameters during their visit like fasting plasma glucose, post-prandial plasma glucose, lipid profile, renal profile etc. will also be checked. All pregnant women will be screened for GDM at 24-28 weeks by Oral Glucose tolerance test and at the same time thyroid levels (T3, T4, and TSH) will be measured.

This study will help us in solving the unresolved questions of associations of thyroid hormones insensitivity and prevalence of diabetes in euthyroid pregnant females.

 

 
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