Risk Evaluation of cAncers in Chinese diabeTic Individuals: a lONgitudinal Study

NCT01506869 | Unknown DMC

• 1 other identifier: CCEMD010
• Study Type: observational
• Target: 200,000
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cancer

Outcome Measures

Primary Outcomes (1)

• number of participants who develop cancer during follow-up

  3 years

Study Arms (3)

Type 2 diabetes

Prediabetes

Normal glucose regulation

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

In phase 1, 200,000-250,000 individuals selected from 20-25 communities stratified according to geographic regions, degrees of urbanization, and economic development status In Phase 2, 30,000-40,000 type 2 diabetes, 20,000-30,000 prediabetes, 30,000-40,000 normal glucose regulation, recruited from the baseline survey

You may qualify if:

• Age \>= 40 years old
• Gender: males and females
• Provide written informed consent
• Satisfactory compliance
• Phase 2
• Age \>= 40 and =\< 75 years old
• Gender: males and females
• Provide written informed consent
• Satisfactory compliance

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shanghai Jiao Tong University School of Medicine: lead
• Chinese Society of Endocrinology: collaborator

Study Sites (1)

Shanghai Jiao-Tong University School of Medicine

Shanghai, 200025, China

RECRUITING

Related Publications (3)

• Wang L, Wu P, Chen K, Li B, Wang J, Mu Y. Correlation between rate-pressure product or pressure-rate quotient and urinary albumin-creatinine ratio in the Chinese older population: The REACTION study. Chin Med J (Engl). 2024 Jan 20;137(2):238-240. doi: 10.1097/CM9.0000000000002941. Epub 2024 Jan 8. No abstract available.

  PMID: 38185831 DERIVED

• Xu C, Zhou G, Zhao M, Zhang X, Fang L, Guan Q, Zhang H, Gao L, Zhang T, Zhao J. Bidirectional temporal relationship between obesity and hyperinsulinemia: longitudinal observation from a Chinese cohort. BMJ Open Diabetes Res Care. 2021 Feb;9(1):e002059. doi: 10.1136/bmjdrc-2020-002059.

  PMID: 33632707 DERIVED

• Chen Y, Lin H, Qin L, Lu Y, Zhao L, Xia M, Jiang J, Li X, Yu C, Zong G, Zheng Y, Gao X, Su Q, Li X. Fasting Serum Fructose Levels Are Associated With Risk of Incident Type 2 Diabetes in Middle-Aged and Older Chinese Population. Diabetes Care. 2020 Sep;43(9):2217-2225. doi: 10.2337/dc19-2494. Epub 2020 Jul 1.

  PMID: 32611608 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Blood and urine samples were collected and retained for biomarker analysis

MeSH Terms

Conditions

Neoplasms

Study Officials

• Guang Ning, MD,PHD

  Shanghai Jiao Tong University School of Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Guang Ning, MD,PHD

CONTACT

008621 64370045; guangning@medmail.com.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 5, 2012
• First Posted: January 10, 2012
• Study Start: May 1, 2011
• Primary Completion: December 1, 2014
• Study Completion: June 1, 2015
• Last Updated: January 10, 2012

Record last verified: 2012-01

Locations

CN (1)