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临床试验/CTRI/2024/08/072032
CTRI/2024/08/072032尚未招募不适用

Association between insulin resistance with endometrial, ovarian and cervical cancers in non-diabetic women : A Cross sectional study

Dr Parish Kamdi1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2024年8月25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
100
试验地点
1
主要终点
Homeostatic model assessment -insulin resistance calculated as fasting insulin (microU/L) X fasting plasma glucose (mol/L)

研究概览

简要总结

Insulin resistance (IR) refers to cells and tissues becoming insensitive to the peptide hormone, Insulin. It is well-established that hyperinsulinemia, a hallmark of IR, may play a role in tumorigenesis as well as IR is strongly associated with visceral adiposity dysfunction and systemic inflammation, both favouring the establishment of a pro-tumorigenic environment.  Polycystic ovary syndrome (PCOS) frequently shows IR accompanied by an increase of IGF-1 in plasma, being involved in the differentiation of various reproductive tissues, like endometrium and ovarian tissues. Metabolic Syndrome may contribute to viral-host interactions, which lead to persistent human papillomavirus (HPV) infection, leading to increased risk of cervical cancer. A higher risk for cervical, ovarian and endometrial cancer is related to high IGF-1 levels in post- and premenopausal women.   Many international studies have depicted the close association between IR and gynaecological malignancies. However, further evidence needs to be investigated as only a few studies have been published from the Indian subcontinent showing the association between insulin resistance and gynaecological cancers, and hence, this study has been planned to determine the association between insulin resistance and endometrial, ovarian and cervical cancer in non-diabetic women. The primary objective of the study is to evaluate the prevalence of Insulin resistance in non-diabetic women with endometrial, ovarian and cervical cancer. All non-diabetic women with endometrial, ovarian and cervical cancers willing to participate in the study will be recruited from Obstetrics and Gynaecology outpatient or inpatient departments at AIIMS Rishikesh for a period of one year and six months and blood samples will be collected from all patients in resting position and after 8–10 h of fasting and tested for fasting plasma glucose, fasting insulin, lipid profile and Hba1c. HOMA IR will be calculated with the help of fasting plasma glucose and fasting insulin and study population will be divided into two groups, insulin sensitive and insulin resistant and baseline characteristics (age, BMI, menopausal status), anthropometric measures, and metabolic parameters will be compared among insulin-resistant and insulin-sensitive groups.

研究设计

研究类型
Observational

入排标准

年龄范围
15.00 Year(s) 至 90.00 Year(s)(—)
性别
Female

入选标准

  • All non-diabetic women with endometrial, ovarian and cervical cancers who are willing to participate.

排除标准

  • Women with Diabetes Mellitus.

结局指标

主要结局

Homeostatic model assessment -insulin resistance calculated as fasting insulin (microU/L) X fasting plasma glucose (mol/L)

时间窗: Once at the time of recruitment

次要结局

  • Age, menopausal status, parity, history of contraception, smoking or drinking habits, education status, family history of female genital cancer, family history of diabetes, weight, height, BMI, waist circumference, hip circumference, blood pressure, lipid profile , fasting plasma glucose, fasting insulin, HbA1c.(Once at the time of recruitment)

研究者

发起方
Dr Parish Kamdi
申办方类型
Other [Principle Investigator]
责任方
Principal Investigator
主要研究者

Dr Parish Kamdi

AIIMS Rishikesh

研究点 (1)

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