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Understanding of Genetic Risk Information for Type 2 Diabetes

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01186354
Recruitment Status : Completed
First Posted : August 23, 2010
Last Update Posted : December 17, 2012
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Duke University

Brief 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 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.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus, Type 2 Behavioral: Receiving results via genetic counselor Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Implications of Health and Genetic Literacy for Genomic Medicine
Study Start Date : July 2010
Actual Primary Completion Date : January 2012
Actual Study Completion Date : January 2012

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Receiving results via web-based program
participants will receive genetic risk results for Type 2 diabetes via a web-based program that they access on their own
Behavioral: Receiving results via genetic counselor
participants will receive genetic risk information for Type 2 diabetes from a board certified genetic counselor
Other Name: genetic counseling

Primary Outcome Measures :
  1. Accurate understanding of genetic risk information [ Time Frame: assessed at follow-up 1 week, 3 months and 6 months after receiving results ]

Secondary Outcome Measures :
  1. Impact on behavior change [ Time Frame: assessed upon follow-up (3 mon, 6 mon) ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Ages 18 or older
  • Speak fluent English
  • Have an email address and access to the internet
  • Not diagnosed with type 2 diabetes

Exclusion Criteria:


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01186354

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United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27708
Sponsors and Collaborators
Duke University
National Heart, Lung, and Blood Institute (NHLBI)
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Principal Investigator: Susanne B Haga, PhD Duke University Medical Center, Institute for Genome Sciences and Policy

Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Duke University Identifier: NCT01186354     History of Changes
Other Study ID Numbers: Pro00021370
1R21HL096573-01A1 ( U.S. NIH Grant/Contract )
First Posted: August 23, 2010    Key Record Dates
Last Update Posted: December 17, 2012
Last Verified: December 2012

Keywords provided by Duke University:
Type 2 diabetes
health literacy
genetic literacy
genetic risk

Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases