- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT00849563
Effect of Type 2 Diabetes Genetic Risk Information on Health Behaviors and Outcomes (TDE)
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
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.
Studietype
Registrering (Faktiske)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
-
-
North Carolina
-
Durham, North Carolina, Forente stater, 27705
- Duke Family Medicine at Pickens
-
Durham, North Carolina, Forente stater, 27705
- Duke Health Center at Pickett Rd
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
Inclusion Criteria:
- 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
- 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
Exclusion Criteria:
- 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
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Forebygging
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Enkelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
---|---|
Aktiv komparator: SRA+genetic test
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
|
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.
|
Ingen inngripen: SRA only
Patients randomized to not get genetic testing will be followed and surveyed and will be counseled based on SRA only
|
|
Ingen inngripen: no testing control
Patients not interested in genetic testing will be followed and surveyed.
Counseling will be based on SRA only
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
---|---|
Percentage of weight loss
Tidsramme: 12 months
|
12 months
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
---|---|
Change in perceptions of personal risk for Type 2 diabetes
Tidsramme: 12 months
|
12 months
|
Change in HOmeostasis Model Assessment of Insulin Resistance (HOMA-IR)
Tidsramme: 12 months
|
12 months
|
Samarbeidspartnere og etterforskere
Sponsor
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Geoffrey Ginsburg, Md, PhD, Institute for Genome Sciences and Policy, Duke University
- Hovedetterforsker: Alex Cho, MD, Institute for Genome Sciences and Policy, Duke University
- Hovedetterforsker: Scott Joy, MD, Duke University
- Hovedetterforsker: Susanne Haga, PhD, Institute for Genome Sciences and Policy, Duke University
- Hovedetterforsker: Isaac Lipkus, PhD, Institute for Genome Sciences and Policy, Duke University
- Hovedetterforsker: Gloria Trujillo, MD, Duke University
- Hovedetterforsker: Julianne O'Daniel, PhD, Institute for Genome Sciences and Policy, Duke University
Publikasjoner og nyttige lenker
Generelle publikasjoner
- 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.
- Cho 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.
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- Pro00011592
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