Diabetes Mellitus, Type 2TDENCT00849563
Effect of Type 2 Diabetes Genetic Risk Information on Health Behaviors and Outcomes
A study testing Standardized Risk Assessment in people with Diabetes Mellitus, Type 2, run by Duke University at 2 sites in United States.
Trial summary
The primary objective of the study is to assess the clinical utility of a genetic test for Type 2 diabetes risk in combination with standardized risk assessment compared with standardized risk assessment alone, and to measure whether changes in perceived risk following genetic testing for Type 2 diabetes risk are… Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- Standardized Risk Assessment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 450 participants
- Where
- 2 sitesUnited States
- Study dates
- Apr 2009to Jun 2013
- 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 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Are male or female outpatients
- No self-reported history of diabetes
- No self-reported history of prior genetic testing for diabetes
- Not pregnant (self report)
- Are ≥18 and <81 years of age
- Scheduled to receive serum glucose test in participating clinic
Show all 10Show fewer
- Fasting at time of blood draw (no food or drink - except water - previous 8 hours: self report)
- Able and willing to give legally effective consent
- Able and willing to participate in patient questionnaires
- Ambulatory
Who cannot join
- Previously or currently taking medications for lowering glucose (i.e., exenatide, pramlintide, metformin, rosiglitazone, pioglitazone, or future diabetes drugs) based on self-report and/or prescreening
- Self-report of current or prior diabetes diagnosis
- Self-reported prior history of genetic testing for diabetes
- Baseline serum glucose test result >125
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Duke Family Medicine at Pickens
Durham, North Carolina, 27705
Duke Health Center at Pickett Rd
Durham, North Carolina, 27705
About this study
The primary objective of the study is to assess the clinical utility of a genetic test for Type 2 diabetes risk in combination with standardized risk assessment compared with standardized risk assessment alone, and to measure whether changes in perceived risk following genetic testing for Type 2 diabetes risk are correlated with behavior change and increased concern about risk for Type 2 diabetes.
Read the detailed description
One thousand outpatients will be enrolled over two years at two university-affiliated primary care clinics. Patients will be assigned to one of three study arms: those who want genetic testing for diabetes risk will be randomly assigned to either receive the testing in addition to the SRA (SRA+G) or to receive the SRA only (SRA-only). Those who do not wish to have genetic testing will receive the SRA only. All patients will be surveyed at baseline, immediately after going through the SRA (risk-counseling visit; 2-4 weeks after initial visit), at 3 months post risk counseling visit and at 12 months post risk counseling visit. BMI, waist circumference, fasting plasma glucose and insulin will be measured at baseline and 12 months. Surveys will allow us to track patients' emotional responses to diabetes risk information and changing perceptions of personal risk for Type 2 diabetes over time, and to see if these correlate with subsequent diet and exercise behaviors.
We will use a linear model to assess the effects of genetic testing among the three study groups, using HOmeostasis Model Assessment of Insulin Resistance (HOMA-IR) and weight loss as the primary outcomes. We will use generalized linear ordinal regression models to fit the ordinal survey outcomes of risk perceptions to the continuous HOMA-IR and weight outcome variables.
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- Standardized Risk Assessment
- Keywords
- predictive genomics, personalized medicine, personal genomics, genetic knowledge, genetic attitudes, prevention, health outcomes, behavioral
- Medical subject headings
- Diabetes Mellitus, Type 2, Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standardized Risk AssessmentOther
patients interested in genetic testing will be randomly assigned to either get testing for type 2 diabetes or not. All arms with receive standardized risk asessements. This study is evaluating behavior after receipt of genetic risk information and different types of counseling.
| Study group | Role | What they receive |
|---|---|---|
| SRA+genetic test | Active comparator | patients randomized to receive genetic test for type 2 diabetes risk will be followed and surveyed and will be counseled based on SAR and genetic risk for type 2 diabetes Receives: Other: Standardized Risk Assessment |
| SRA only | No intervention | Patients randomized to not get genetic testing will be followed and surveyed and will be counseled based on SRA only |
| no testing control | No intervention | Patients not interested in genetic testing will be followed and surveyed. Counseling will be based on SRA only |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of weight loss
Measured: 12 months
Secondary outcomes (2)
Change in perceptions of personal risk for Type 2 diabetes
Measured: 12 months
Change in HOmeostasis Model Assessment of Insulin Resistance (HOMA-IR)
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2009 (estimated)
- Study startApr 2009
- Primary completionSep 2011
- Study completionJun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 450 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- deCODE genetics
- Responsible party
- Sponsor
- Investigators
- Geoffrey Ginsburg, Md, PhD, Principal investigator, Institute for Genome Sciences and Policy, Duke UniversityAlex Cho, MD, Principal investigator, Institute for Genome Sciences and Policy, Duke UniversityScott Joy, MD, Principal investigator, Duke UniversitySusanne Haga, PhD, Principal investigator, Institute for Genome Sciences and Policy, Duke UniversityIsaac Lipkus, PhD, Principal investigator, Institute for Genome Sciences and Policy, Duke UniversityGloria Trujillo, MD, Principal investigator, Duke UniversityJulianne O'Daniel, PhD, Principal investigator, Institute for Genome Sciences and Policy, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00849563
- Sponsor's protocol ID
- Pro00011592
- Acronym
- TDE
- Status last verified
- Apr 2014
- First submitted
- 22 Feb 2009
- Last updated
- 10 Apr 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Waxler 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 22302620Cho AH, Killeya-Jones LA, O'Daniel JM, Kawamoto K, Gallagher P, Haga S, Lucas JE, Trujillo GM, Joy SV, Ginsburg GS. Effect of genetic testing for risk of type 2 diabetes mellitus on health behaviors and outcomes: study rationale, development and design. BMC Health Serv Res. 2012 Jan 18;12:16. doi: 10.1186/1472-6963-12-16.
PubMed 22257365
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Type 2 Diabetes Genetic Risk Information on Health Behaviors and Outcomes
- ClinicalTrials.gov ID
- NCT00849563
- Acronym / sponsor ID
- TDE / Pro00011592
- Conditions
- Diabetes Mellitus, Type 2
- Keywords
- predictive genomics, personalized medicine, personal genomics, genetic knowledge, genetic attitudes, prevention, health outcomes, behavioral
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 450 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- deCODE genetics
- Study start
- Apr 2009
- Primary completion
- Sep 2011 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 24 Feb 2009 (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.
The primary objective of the study is to assess the clinical utility of a genetic test for Type 2 diabetes risk in combination with standardized risk assessment compared with standardized risk assessment alone, and to measure whether changes in perceived risk following genetic testing for Type 2 diabetes risk are correlated with behavior change and increased concern about risk for Type 2 diabetes.
Detailed description
One thousand outpatients will be enrolled over two years at two university-affiliated primary care clinics. Patients will be assigned to one of three study arms: those who want genetic testing for diabetes risk will be randomly assigned to either receive the testing in addition to the SRA (SRA+G) or to receive the SRA only (SRA-only). Those who do not wish to have genetic testing will receive the SRA only. All patients will be surveyed at baseline, immediately after going through the SRA (risk-counseling visit; 2-4 weeks after initial visit), at 3 months post risk counseling visit and at 12 months post risk counseling visit. BMI, waist circumference, fasting plasma glucose and insulin will be measured at baseline and 12 months. Surveys will allow us to track patients' emotional responses to diabetes risk information and changing perceptions of personal risk for Type 2 diabetes over time, and to see if these correlate with subsequent diet and exercise behaviors.
We will use a linear model to assess the effects of genetic testing among the three study groups, using HOmeostasis Model Assessment of Insulin Resistance (HOMA-IR) and weight loss as the primary outcomes. We will use generalized linear ordinal regression models to fit the ordinal survey outcomes of risk perceptions to the continuous HOMA-IR and weight outcome variables.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| SRA+genetic test | Active comparator | Other: Standardized Risk Assessmentpatients randomized to receive genetic test for type 2 diabetes risk will be followed and surveyed and will be counseled based on SAR and genetic risk for type 2 diabetes |
| SRA only | No intervention | –Patients randomized to not get genetic testing will be followed and surveyed and will be counseled based on SRA only |
| no testing control | No intervention | –Patients not interested in genetic testing will be followed and surveyed. Counseling will be based on SRA only |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Are male or female outpatients
- No self-reported history of diabetes
- No self-reported history of prior genetic testing for diabetes
- Not pregnant (self report)
- Are ≥18 and <81 years of age
Key exclusion criteria (4 listed)
- Previously or currently taking medications for lowering glucose (i.e., exenatide, pramlintide, metformin, rosiglitazone, pioglitazone, or future diabetes drugs) based on self-report and/or prescreening
- Self-report of current or prior diabetes diagnosis
- Self-reported prior history of genetic testing for diabetes
- Baseline serum glucose test result >125
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 |
|---|---|---|
| Standardized Risk Assessmentpatients interested in genetic testing will be randomly assigned to either get testing for type 2 diabetes or not. All arms with receive standardized risk asessements. This study is evaluating behavior after receipt of genetic risk information and different types of counseling. | Other | SRA+genetic test |
Primary outcome
Percentage of weight loss
Time frame: 12 months
2 secondary outcomes
Change in perceptions of personal risk for Type 2 diabetes
Time frame: 12 months
Change in HOmeostasis Model Assessment of Insulin Resistance (HOMA-IR)
Time frame: 12 months
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 10 Apr 2014.
- 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.
- Derived from this study: PubMed 22257365Cho AH, Killeya-Jones LA, O'Daniel JM, Kawamoto K, Gallagher P, Haga S, Lucas JE, Trujillo GM, Joy SV, Ginsburg GS. Effect of genetic testing for risk of type 2 diabetes mellitus on health behaviors and outcomes: study rationale, development and design. BMC Health Serv Res. 2012 Jan 18;12:16. doi: 10.1186/1472-6963-12-16.
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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.
Geoffrey Ginsburg, Md, PhD principal investigator
Institute for Genome Sciences and Policy, Duke University
Alex Cho, MD principal investigator
Institute for Genome Sciences and Policy, Duke University
Scott Joy, MD principal investigator
Duke University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standardized Risk Assessment in people with Diabetes Mellitus, Type 2, run by Duke University 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 10 inclusion and 4 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 10 Apr 2014. 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?
Percentage of weight loss (time frame: 12 months). 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 NCT00849563, which also lists 2 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 10 Apr 2014.