Diabetes Mellitus, Type 2NCT01186354
Understanding of Genetic Risk Information for Type 2 Diabetes
A study testing Receiving results via genetic counselor in people with Diabetes Mellitus, Type 2, run by Duke University at 1 site in United States.
Trial summary
This research study is being conducted to learn about how health and genetic literacy (i.e., how well a person understands health and genetic information) affects a person's ability to understand genetic risk information for Type 2 diabetes and whether that person chooses to change their lifestyle and health behaviors… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- Receiving results via genetic counselor
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2010to Jan 2012
- Phase
- Interventional
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Ages 18 or older
- Speak fluent English
- Have an email address and access to the internet
- Not diagnosed with type 2 diabetes
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke University Medical Center
Durham, North Carolina, 27708
About this study
Official title: Implications of Health and Genetic Literacy for Genomic Medicine
This research study is being conducted to learn about how health and genetic literacy (i.e., how well a person understands health and genetic information) affects a person's ability to understand genetic risk information for Type 2 diabetes and whether that person chooses to change their lifestyle and health behaviors to reduce their risk. The investigators also want to learn if the manner in which the genetic risk information is communicated affects the level of understanding and potential behavior changes. Participants will be tested for genetic risk of developing Type 2 diabetes and will received results either via a web-based computer program, or in-person from a genetic counselor.
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- Receiving results via genetic counselor
- Keywords
- Type 2 diabetes, health literacy, genetic literacy, genetic risk
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Receiving results via genetic counselorBehavioural
Also called genetic counseling
participants will receive genetic risk information for Type 2 diabetes from a board certified genetic counselor
| Study group | Role | What they receive |
|---|---|---|
| Receiving results via web-based program | Experimental | participants will receive genetic risk results for Type 2 diabetes via a web-based program that they access on their own Receives: Behavioral: Receiving results via genetic counselor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accurate understanding of genetic risk information
Measured: assessed at follow-up 1 week, 3 months and 6 months after receiving results
Secondary outcomes (1)
Impact on behavior change
Measured: assessed upon follow-up (3 mon, 6 mon)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2010 (estimated)
- Study startJul 2010
- Primary completionJan 2012
- Study completionJan 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- More trials run by Duke UniversityThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Sponsor
- Investigators
- Susanne B Haga, PhD, Principal investigator, Duke University Medical Center, Institute for Genome Sciences and Policy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01186354
- Sponsor's protocol ID
- Pro00021370
- Other IDs
- 1R21HL096573-01A1
- Status last verified
- Dec 2012
- First submitted
- 22 Jul 2010
- Last updated
- 17 Dec 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Mills R, Powell J, Barry W, Haga SB. Information-seeking and sharing behavior following genomic testing for diabetes risk. J Genet Couns. 2015 Feb;24(1):58-66. doi: 10.1007/s10897-014-9736-1. Epub 2014 Jun 14.
PubMed 24927802Haga SB, Barry WT, Mills R, Svetkey L, Suchindran S, Willard HF, Ginsburg GS. Impact of delivery models on understanding genomic risk for type 2 diabetes. Public Health Genomics. 2014;17(2):95-104. doi: 10.1159/000358413. Epub 2014 Feb 27.
PubMed 24577154Haga SB, Barry WT, Mills R, Ginsburg GS, Svetkey L, Sullivan J, Willard HF. Public knowledge of and attitudes toward genetics and genetic testing. Genet Test Mol Biomarkers. 2013 Apr;17(4):327-35. doi: 10.1089/gtmb.2012.0350. Epub 2013 Feb 13.
PubMed 23406207Waxler JL, O'Brien KE, Delahanty LM, Meigs JB, Florez JC, Park ER, Pober BR, Grant RW. Genetic counseling as a tool for type 2 diabetes prevention: a genetic counseling framework for common polygenetic disorders. J Genet Couns. 2012 Oct;21(5):684-91. doi: 10.1007/s10897-012-9486-x.
PubMed 22302620
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implications of Health and Genetic Literacy for Genomic Medicine
- ClinicalTrials.gov ID
- NCT01186354
- Acronym / sponsor ID
- Pro00021370
- Conditions
- Diabetes Mellitus, Type 2
- Keywords
- Type 2 diabetes, health literacy, genetic literacy, genetic risk
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- Jul 2010
- Primary completion
- Jan 2012 (actual)
- Study completion
- Jan 2012 (actual)
- First posted
- 23 Aug 2010 (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 research study is being conducted to learn about how health and genetic literacy (i.e., how well a person understands health and genetic information) affects a person's ability to understand genetic risk information for Type 2 diabetes and whether that person chooses to change their lifestyle and health behaviors to reduce their risk. The investigators also want to learn if the manner in which the genetic risk information is communicated affects the level of understanding and potential behavior changes. Participants will be tested for genetic risk of developing Type 2 diabetes and will received results either via a web-based computer program, or in-person from a genetic counselor.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Receiving results via web-based program | Experimental | Behavioral: Receiving results via genetic counselorparticipants will receive genetic risk results for Type 2 diabetes via a web-based program that they access on their own |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Ages 18 or older
- Speak fluent English
- Have an email address and access to the internet
- Not diagnosed with type 2 diabetes
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Receiving results via genetic counselorAlso: genetic counselingparticipants will receive genetic risk information for Type 2 diabetes from a board certified genetic counselor | Behavioural | Receiving results via web-based program |
Primary outcome
Accurate understanding of genetic risk information
Time frame: assessed at follow-up 1 week, 3 months and 6 months after receiving results
1 secondary outcome
Impact on behavior change
Time frame: assessed upon follow-up (3 mon, 6 mon)
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 17 Dec 2012.
- Derived from this study: PubMed 24927802Mills R, Powell J, Barry W, Haga SB. Information-seeking and sharing behavior following genomic testing for diabetes risk. J Genet Couns. 2015 Feb;24(1):58-66. doi: 10.1007/s10897-014-9736-1. Epub 2014 Jun 14.
- Derived from this study: PubMed 24577154Haga SB, Barry WT, Mills R, Svetkey L, Suchindran S, Willard HF, Ginsburg GS. Impact of delivery models on understanding genomic risk for type 2 diabetes. Public Health Genomics. 2014;17(2):95-104. doi: 10.1159/000358413. Epub 2014 Feb 27.
- Derived from this study: PubMed 23406207Haga SB, Barry WT, Mills R, Ginsburg GS, Svetkey L, Sullivan J, Willard HF. Public knowledge of and attitudes toward genetics and genetic testing. Genet Test Mol Biomarkers. 2013 Apr;17(4):327-35. doi: 10.1089/gtmb.2012.0350. Epub 2013 Feb 13.
- Derived from this study: PubMed 22302620Waxler JL, O'Brien KE, Delahanty LM, Meigs JB, Florez JC, Park ER, Pober BR, Grant RW. Genetic counseling as a tool for type 2 diabetes prevention: a genetic counseling framework for common polygenetic disorders. J Genet Couns. 2012 Oct;21(5):684-91. doi: 10.1007/s10897-012-9486-x.
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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.
Susanne B Haga, PhD principal investigator
Duke University Medical Center, Institute for Genome Sciences and Policy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Receiving results via genetic counselor in people with Diabetes Mellitus, Type 2, run by Duke University at 1 site 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 4 inclusion and 1 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 17 Dec 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Accurate understanding of genetic risk information (time frame: assessed at follow-up 1 week, 3 months and 6 months after receiving results). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01186354, which also lists 4 linked publications.
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 17 Dec 2012.