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Clinical Trial Summary

Background:

Diabetes has been associated with many cancers including liver, pancreas, endometrial, colorectal, breast and bladder cancer. Excess body fat has also been linked to cancer. One reason for this might be resistance to insulin. Researchers want to look for links between insulin, diabetes, and certain cancers. They want to study data that has already been collected.

Objectives:

To study links between insulin, diabetes, and cancers. To study how the links might differ by gender, race, and other factors.

Eligibility:

People who already participated in 1 of 8 cardiovascular disease studies

Design:

Researchers will study data that has already been collected. There will be no active participants.

Participants gave permission to share their data. The data contain no personally identifying information. Researchers will look at biomarkers like diet, medicines, and tobacco use. They will do statistical analysis of the data


Clinical Trial Description

There are multiple biological mechanisms that have been proposed for the association between obesity and cancer including hormonal disruption (adipokines), inflammation, and growth factor stimulation. A common unifying feature of all of these is insulin resistance, which is strongly related to overweight and obesity. To extend the insulin and diabetes hypotheses, we propose pooling data from eight well phenotyped cardiovascular disease cohorts (Atherosclerosis Risk in Community-ARIC, Cardiovascular Health Study-CHS, Framingham study, Multi-Ethnic Study of Atherosclerosis-MESA, Coronary Artery Risk Development in Young Adults-CARDIA, Jackson Heart Study, and Honolulu Heart Program-HHP) to examine associations for lung, pancreatic cancers, and possibly other cancers. These cohorts are ethnically diverse and have fasting insulin and glucose measured at least 1 time during the study, measured anthropometrics (including repeated measures of weight and BMI), lifestyle including diet, tobacco, and alcohol use, and health history. Most of the studies have other clinically measured biomarkers (e.g. CRP, HBA1c, hematology, and chemistry panel). We estimate that the combined cohorts will total approximately 57,000 participants. Although none of the individual cohorts have sufficient numbers of lung or pancreatic cancer cases alone, combined they will facilitate an adequately powered study. This study uses anonomized data from Biolinc. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03534232
Study type Observational
Source National Institutes of Health Clinical Center (CC)
Contact
Status Enrolling by invitation
Phase
Start date June 22, 2018
Completion date March 19, 2020

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