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A Biobehavioral Model of Diabetes Risk in Chinese Immigrants

Sponsor
Fox Chase Cancer Center (Other)
Overall Status
Completed
CT.gov ID
NCT02449213
Collaborator
(none)
650
Enrollment
1
Location
61.8
Actual Duration (Months)
10.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This prospective, longitudinal study of Chinese American immigrants will examine whether psychosocial factors (e.g., acculturative stress, social isolation, discrimination) are associated with markers of type 2 diabetes risk over time, and whether such associations are mediated by inflammatory pathways.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    It is now well-documented that immigration to the US leads to increased risk for various chronic diseases, including type 2 diabetes. The increased diabetes risk observed among Chinese immigrants has been primarily attributed to changes in diet and weight gain following immigration, but these changes can only partially explain disparities in disease risk. Models of immigrant health suggest that the stress of adapting to life in a new country has a considerable impact on physical health. However, few studies have considered the psychosocial impact of immigration upon biomarkers of health and disease risk. Therefore, this longitudinal study of US Chinese immigrant men and women will examine: (1) whether psychosocial factors (e.g., acculturative stress, social isolation, discrimination) are associated with markers of type 2 diabetes risk over time; and (2) whether the association between psychosocial factors and diabetes risk markers is mediated by inflammatory pathways.

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    650 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    A Biobehavioral Model of Diabetes Risk in Chinese Immigrants
    Actual Study Start Date :
    Mar 11, 2016
    Actual Primary Completion Date :
    May 5, 2021
    Actual Study Completion Date :
    May 5, 2021

    Outcome Measures

    Primary Outcome Measures

    1. Insulin resistance [24 months post-baseline]

      Insulin resistance will be estimated according to the homeostasis model assessment (HOMA) as HOMA = (fasting insulin x fasting glucose) / 22.5

    Secondary Outcome Measures

    1. glycated hemoglobin (HbA1c) [24-months post-baseline]

      Level of blood sugar

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    35 Years to 65 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    • Chinese heritage;

    • migration from Asia in adulthood (aged 18 years or older); and

    • age 35-65 years

    Exclusion Criteria:

    • Current or prior history of diabetes

    • Self-reported conditions of cancer, auto-immune disorders, HIV, or psychiatric illness

    • Use of medications that may impact study outcomes (e.g., steroidal or non-steroidal anti-inflammatory medications)

    • Inability to provide informed consent.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Fox Chase Cancer Center Philadelphia Pennsylvania United States 19111

    Sponsors and Collaborators

    • Fox Chase Cancer Center

    Investigators

    • Principal Investigator: Carolyn Y. Fang, PhD, Fox Chase Cancer Center

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Fox Chase Cancer Center
    ClinicalTrials.gov Identifier:
    NCT02449213
    Other Study ID Numbers:
    • 15-8006
    First Posted:
    May 20, 2015
    Last Update Posted:
    Jun 4, 2021
    Last Verified:
    Jun 1, 2021
    Additional relevant MeSH terms:
    Diabetes Mellitus
    Diabetes Mellitus, Type 2

    Study Results

    No Results Posted as of Jun 4, 2021