Diabetes Mellitus, Type 2NCT01749345
Social Determinants of Health in Diabetes Outcomes
An observational study of Diabetes Mellitus, Type 2, run by Medical University of South Carolina at 2 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Mellitus, Type 2
- How many people
- 650 participants
- Where
- 2 sitesUnited States
- Study dates
- Jul 2012to Aug 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Pimary care and internal medicine clinics
Who may be able to join
- Clinical diagnosis of type 2 diabetes
- Able to communicate in English
Who cannot join
- Mental confusion on interview suggesting significant dementia
- Alcohol or drug abuse/dependency
- Active psychosis or acute mental disorder
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Ralph H. Johnson VA Medical Center
Charleston, South Carolina, 29401
Medical University of South Carolina
Charleston, South Carolina, 29425
About this study
Official title: Social Determinants of Health as Explanatory Factors for Ethnic Disparities in Diabetes Outcomes
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.
- Conditions
- Diabetes Mellitus, Type 2
- Medical subject headings
- Diabetes Mellitus, Type 2
What is being measured
The primary outcome is the main question the study is designed to answer.
HbA1C
Measured: Within 3 months prior to the assessment
Quality of life
Measured: Within a month of completely the assessment
Secondary outcomes (2)
Blood pressure
Measured: Most recent to assessment date
Low density lipoprotein (LDL) Cholesterol
Measured: Most recent to assessment date
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2012 (estimated)
- Study startJul 2012
- Primary completionAug 2014
- Study completionAug 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- More trials run by Medical University of South CarolinaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 650 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of South Carolina
- Sponsor type
- University, hospital or other
- Collaborators
- Ralph H. Johnson VA Medical Center, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Responsible party
- Sponsor
- Investigators
- Leonard E Egede, M.D., Principal investigator, Medical University of South Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01749345
- Sponsor's protocol ID
- 17676
- Other IDs
- 1K24DK093699-01
- Status last verified
- May 2018
- First submitted
- 11 Dec 2012
- Last updated
- 8 May 2018
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Social Determinants of Health as Explanatory Factors for Ethnic Disparities in Diabetes Outcomes
- ClinicalTrials.gov ID
- NCT01749345
- Acronym / sponsor ID
- 17676
- Conditions
- Diabetes Mellitus, Type 2
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 650 participants (actual)
- Lead sponsor
- Medical University of South CarolinaUniversity, hospital or other
- Collaborators
- Ralph H. Johnson VA Medical Center, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- Jul 2012
- Primary completion
- Aug 2014 (actual)
- Study completion
- Aug 2014 (actual)
- First posted
- 13 Dec 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Pimary care and internal medicine clinics
Key inclusion criteria (2 listed)
- Clinical diagnosis of type 2 diabetes
- Able to communicate in English
Key exclusion criteria (3 listed)
- Mental confusion on interview suggesting significant dementia
- Alcohol or drug abuse/dependency
- Active psychosis or acute mental disorder
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
HbA1C
Time frame: Within 3 months prior to the assessment
Quality of life
Time frame: Within a month of completely the assessment
2 secondary outcomes
Blood pressure
Time frame: Most recent to assessment date
Low density lipoprotein (LDL) Cholesterol
Time frame: Most recent to assessment date
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Leonard E Egede, M.D. principal investigator
Medical University of South Carolina
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes Mellitus, Type 2, run by Medical University of South Carolina at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HbA1C (time frame: Within 3 months prior to the assessment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2018.