跳至主要内容
临床试验/NCT01506869
NCT01506869Unknown不适用

A Prospective Cohort Study on the Associations of Diabetes With Cancer Risk in Chinese Men and Women

Shanghai Jiao Tong University School of Medicine1 个研究点 分布在 1 个国家目标入组 200,000 人开始时间: 2011年5月最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
200,000
试验地点
1
主要终点
number of participants who develop cancer during follow-up

研究概览

简要总结

Phase 1: Baseline investigation (nation-wide survey)

Aims: To investigate whether diabetes and prediabetes is a risk factor for cancers of all sites as well as for specific type of cancer, such as breast and colorectal cancer.

Subjects and Methods: A nation-wide survey will be carried out in 200,000-250,000 individuals selected from 20-25 communities stratified according to geographic regions (northeast, north, east, south central, northwest, and southwest China), degrees of urbanization (large cities [Beijing, Shanghai, and provincial capitals], midsize cities, county seats, and rural townships), and economic development status (as assessed on the basis of the gross domestic product [GDP] for each province). A comprehensive examination including questionnaire, anthropometric measurements, biochemical analysis will be performed in each study participant. Diabetes and prediabetes should be diagnosed by OGTT according to the WHO 1999 criteria, while the diagnosis of cancer is established on the self-report questionnaire and cross checking with the tumor registry or a proof of doctor's diagnosis.

Phase 2: Cohort follow-up

Aims : To examine factors that modify the risk of cancer in diabetes, prediabetes and normal glucose regulation (NGR).

Subjects and Methods: To recruit and follow all type 2 diabetes, prediabetes, and sex,age-matched NGR (1:1) in each community for at least 3 years. For diabetes, treatment target is HbA1c ≤ 7.0% with treatment paradigm recommended by local guideline.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
40 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age >= 40 years old
  • Gender: males and females
  • Provide written informed consent
  • Satisfactory compliance
  • Inclusion Criteria:
  • Age >= 40 and =< 75 years old
  • Gender: males and females
  • Provide written informed consent
  • Satisfactory compliance

排除标准

  • History of cancer;
  • History of LADA and other autoimmunity diseases;
  • Acute diabetic complication, acidosis, etc;
  • Moderate to severe liver, kidney dysfunction, i.e. ALT/AST > 2.5 times the upper limit of normal range or Ccr < 25ml/min;
  • Any other condition or major systemic diseases that the investigator feels would interfere with trial participation or evaluation of results.

结局指标

主要结局

number of participants who develop cancer during follow-up

时间窗: 3 years

次要结局

未报告次要终点

研究者

发起方
Shanghai Jiao Tong University School of Medicine
申办方类型
Other
责任方
Principal Investigator
主要研究者

Guang Ning

Professor

Shanghai Jiao Tong University School of Medicine

研究点 (1)

Loading locations...

相似试验