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临床试验/CTRI/2023/11/059858
CTRI/2023/11/059858已完成不适用

Sonographic measurement of maternal adipose tissue thickness in first trimester and the risk of developing gestational diabetes mellitus in later pregnancy

Kasturba Medical College MANIPAL1 个研究点 分布在 1 个国家目标入组 601 人开始时间: 2023年11月23日最近更新:

试验速览

阶段
不适用
状态
已完成
入组人数
601
试验地点
1
主要终点
Positively diagnosed gestational diabetes mellitus patients will be assessed and correlated with their previously measured adipose tissue thickness during 1st Trimester and its risk being evaluated.

研究概览

简要总结

Eligible Pregnant women between 11-14weeks of gestation are recruited from OBG OPD during their routine antenatal checkup or during their in patient stay.RBS >200mg/dl or HBA1C >6.5% was described as overt diabetic and Patients with Pre existing type 1 or 2 DM ,and patients with  increased pre-conceptional BMI (>26)are not eliglible for  study.

Detailed description of the study procedure will be explained to them and  the willing and eligible participants will be recruited after Informed written consent.

All the patients will undergo transabdominal sonographic measurements of subcutaneous and visceral adipose tissue during 11-14weeks of gestation. It was performed using a 3.5-5.5MHz TAS probe-(Philips ClearVue ultrasound system).

Subcutaneous adipose tissue thickness is measured as maximum vertical distance from the skin line to edge of linea alba, immediately caudal to xiphoid tip.

The visceral adipose tissue was measured from posterior edge of linea alba to anterior surface of liver.

Three measurements were done and their mean value is obtained. All these Patients will be (Contacted through telephone) and followed up during 2nd trimester, and will undergo 75g OGTT between 24-28weeks of period of gestation.

The test was done following a 12hour fast, with sampling at 1hour and two hours post load.

Diagnostic criteria of GDM( IADPSG criteria):

Fasting glucose>92mg/dl

Postprandial 1hr>180mg/dl

Postprandial 2hr>153mg/dl

One or more abnormal values from the 75g OGTT are diagnosed as  GDM.  Positively diagnosed GDM  and negatively diagnosed GDM patients  will be  differntiated into two groups and are compared with their previously measured adipose tissue thickness during 1st Trimester and its risk being evaluated.

研究设计

研究类型
Observational

入排标准

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

入选标准

  • Pregnant women aged between 21-45years 2)Singleton pregnancies of 11-14weeks of gestation.

排除标准

  • Women aged <21 and > 46years 2)Pre existing diabetes 3)Twin pregnancies 4)Presence of any fetal abnormalities 5)Pre conceptional BMI >26.

结局指标

主要结局

Positively diagnosed gestational diabetes mellitus patients will be assessed and correlated with their previously measured adipose tissue thickness during 1st Trimester and its risk being evaluated.

时间窗: Sonographic measurement of maternal adipose tissue thickness will be measured at the time of NT Scan(11-14weeks of gestation) | GTT is done during 2nd Trimester (preferably 24-28weeks of gestation)

次要结局

  • Positively diagnosed GDM patients will be assessed and correlated with their previously measured adipose tissue thickness during 1st Trimester and its risk being evaluated.(During NT Scan and 2nd Trimester of pregnancy)

研究者

申办方类型
Private medical college
责任方
Principal Investigator
主要研究者

UMASREE DEVAGIRI

KMC,MANIPAL

研究点 (1)

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