Insulin-Related Biomarkers and Exposures and Risk of Pancreatic, Lung, and Other Cancers

Obesity Clinical Trial

Official title:

Insulin-related Biomarkers and Exposures and Risk of Pancreatic, Lung and Other Cancers

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT03534232
• Other study ID #: 999918094
• Secondary ID: 18-C-N094
• Status: Enrolling by invitation
• Start date: June 22, 2018
• Est. completion date: March 19, 2020

Study information

• Verified date: May 8, 2018
• Source: National Institutes of Health Clinical Center (CC)
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

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

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 57031
• Est. completion date: March 19, 2020
• Est. primary completion date: March 19, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Years to 89 Years

Eligibility

• All data included in this pooling project are being provided through an NHLBI biorepository. The biorepository is called: BioLINCC.

Related Conditions & MeSH terms

• Diabetes
• Insulin Resistance
• Obesity

Locations

Country	Name	City	State
United States	National Cancer Institute (NCI)	Bethesda	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cancer incidence	Pancreatic ductal adenocarcinoma, lung, and other cancers. The follow-up time will vary across the cohorts. The Honolulu Heart Program has follow-up between 1965 and 1998. The other more contemporary cohorts have follow-up between baseline and current times. We will use the followup provided by Biolinc. We will go to individual cohorts via Biolinc for additional follow-up beyond what is in Biolinc.	from baseline to most recent follow-up
Secondary	Diabetes, obesity, and mortality		baseline to more recent follow-up