Overview

This trial is active, not recruiting.

Conditions diabetes, cancer
Sponsor Sheba Medical Center
Collaborator European Foundation for the Study of Diabetes
Start date March 2012
End date December 2014
Trial size 2188669 participants
Trial identifier NCT02072902, SHEBA-14-0050-RD-CTIL

Summary

This is a large nationwide population study, with 10 year follow-up, of the effect of diabetes, metabolic control and a large number of glucose-lowering medications, on total and site-specific cancer incidence and survival.

The study is based on electronic medical records from the largest Israeli health maintenance organization in Israel, Clalit Health Services. 2,301,990 insurees age 21 years old or above at study entry, January 2002 will be included. Four study groups will be established according to the prevalence of diabetes and/or cancer on that date: neither diabetes nor cancer; prevalent diabetes but not cancer; prevalent cancer but not diabetes; both diabetes and cancer prevalence. Subjects free of diabetes at study entry will be followed for diabetes incidence, and all four groups will be followed until December 2012 for study outcomes. The cohort data file will be linked to the Israel National Cancer Registry for cancer morbidity.

We will compare, after adjustment, all and site-specific cancer rates between individuals with and without diabetes; and investigate if metabolic control, as indicated by HbA1c and blood glucose levels, is related to cancer risk. Using time-dependent Cox proportionate hazard models, we will then evaluate differences in outcomes that associate with the use of one or a combination of glucose-lowering treatments, while stratifying by those who were already diagnosed with diabetes at study entry, and those diagnosed during follow-up. Data for a large number of potential confounding variables, including BMI, plasma glucose, HbA1c, hormone replacement therapy and comorbidities will help mitigate allocation bias. The accessibility and uniformity of the healthcare provided by Clalit Health Services, as well as data on cancer screening tests, will minimize the risk of surveillance bias.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective retrospective
Arm

Primary Outcomes

Measure
Hazard ratio for cancer
time frame: The population will be followed historically for incidence of cancer for a period of up to 11 years.

Eligibility Criteria

Male or female participants at least 21 years old.

Inclusion Criteria: - Aged older than 21 and younger than 90 at study entry, January 1, 2002 - Insured by Clalit Health Services Exclusion Criteria: - Under age 21 at January 1, 2002 - Over age 90 at January 1, 2002

Additional Information

Official title Diabetes, Glucose Control, Glucose Lowering Medications, and Cancer Risk: A 10-year Population-based Historical Cohort
Principal investigator Rachel Dankner, MD MPH
Trial information was received from ClinicalTrials.gov and was last updated in March 2014.
Information provided to ClinicalTrials.gov by Sheba Medical Center.