- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02449213
A Biobehavioral Model of Diabetes Risk in Chinese Immigrants
June 2, 2021 updated by: Fox Chase Cancer Center
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.
Study Overview
Status
Completed
Conditions
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 Type
Observational
Enrollment (Actual)
650
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Pennsylvania
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Philadelphia, Pennsylvania, United States, 19111
- Fox Chase Cancer Center
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
35 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
600 foreign-born Chinese Americans
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Insulin resistance
Time Frame: 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
|
24 months post-baseline
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
glycated hemoglobin (HbA1c)
Time Frame: 24-months post-baseline
|
Level of blood sugar
|
24-months post-baseline
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Carolyn Y. Fang, PhD, Fox Chase Cancer Center
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 11, 2016
Primary Completion (Actual)
May 5, 2021
Study Completion (Actual)
May 5, 2021
Study Registration Dates
First Submitted
May 17, 2015
First Submitted That Met QC Criteria
May 17, 2015
First Posted (Estimate)
May 20, 2015
Study Record Updates
Last Update Posted (Actual)
June 4, 2021
Last Update Submitted That Met QC Criteria
June 2, 2021
Last Verified
June 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 15-8006
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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