Diabetes Mellitus, Type 2 Clinical Trial
Official title:
Social Determinants of Health as Explanatory Factors for Ethnic Disparities in Diabetes Outcomes
| NCT number | NCT01749345 |
| Other study ID # | 17676 |
| Secondary ID | 1K24DK093699-01 |
| Status | Completed |
| Phase | |
| First received | |
| Last updated | |
| Start date | July 2012 |
| Est. completion date | August 2014 |
| Verified date | May 2018 |
| Source | Medical University of South Carolina |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
This is a cross-sectional study of six hundred adults with type 2 diabetes, (300 White and 300 African-American) who will be recruited from two primary care sites to determine how social determinants of health impact diabetes outcomes. The first aim is to investigate the role of psychosocial factors and SES on diabetes care processes and outcomes. The second aim is to investigate the influence of community and neighborhood characteristics on diabetes care processes and outcomes. Finally, we will examine the contribution of social determinants of health to ethnic differences in diabetes care processes and outcomes. Clinical and metabolic measures will be abstracted from the electronic medical records. Outcome variables include hemoglobin A1c, blood pressure, LDL-Cholesterol and quality of life.
| Status | Completed |
| Enrollment | 650 |
| Est. completion date | August 2014 |
| Est. primary completion date | August 2014 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria: - Clinical diagnosis of type 2 diabetes - Able to communicate in English Exclusion Criteria: - Mental confusion on interview suggesting significant dementia - Alcohol or drug abuse/dependency - Active psychosis or acute mental disorder |
| Country | Name | City | State |
|---|---|---|---|
| United States | Medical University of South Carolina | Charleston | South Carolina |
| United States | Ralph H. Johnson VA Medical Center | Charleston | South Carolina |
| Lead Sponsor | Collaborator |
|---|---|
| Medical University of South Carolina | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), Ralph H. Johnson VA Medical Center |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | HbA1C | Within 3 months prior to the assessment | ||
| Primary | Quality of life | Within a month of completely the assessment | ||
| Secondary | Blood pressure | Most recent to assessment date | ||
| Secondary | Low density lipoprotein (LDL) Cholesterol | Most recent to assessment date |
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