| 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
|
|
|
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
|
|
|
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.
|