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临床试验/CTRI/2025/03/082905
CTRI/2025/03/082905尚未招募不适用

Thyroid hormone indices as biomarkers for risk of gestational diabetes

Department of Health Research1 个研究点 分布在 1 个国家目标入组 400 人开始时间: 2025年4月1日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
400
试验地点
1
主要终点
To investigate the relationship between central thyroid hormone sensitivity and periph eral thyroid hormone sensitivity in euthyroid females with the subsequent risk of GDM

研究概览

简要总结

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.

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 45.00 Year(s)(—)
性别
Female

入选标准

  • 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.

排除标准

  • Pregnant women with pre-existing diabetes (type 1 or 2) or thyroid disorders diagnosed during the first pre-natal examination.
  • Pregnant women with cardiovascular, cerebrovascular, respiratory disease, or systemic illness related to kidneys/liver.
  • Women undergoing medication treatment for diabetes or thyroid function before or during the first trimester or steroid treatment.
  • 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.

结局指标

主要结局

To investigate the relationship between central thyroid hormone sensitivity and periph eral thyroid hormone sensitivity in euthyroid females with the subsequent risk of GDM

时间窗: 3rd trimester

次要结局

  • 2. To examine trimester-specific associations of thyroid sensitivity status and GDM(3 months)

研究者

发起方
Department of Health Research
申办方类型
Government funding agency
责任方
Principal Investigator
主要研究者

Dr Manju Jha

RUHS COLLEGE OF MEDICAL SCIENCES

研究点 (1)

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