- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT00849563
Effect of Type 2 Diabetes Genetic Risk Information on Health Behaviors and Outcomes (TDE)
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Inscription (Réel)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
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North Carolina
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Durham, North Carolina, États-Unis, 27705
- Duke Family Medicine at Pickens
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Durham, North Carolina, États-Unis, 27705
- Duke Health Center at Pickett Rd
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
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
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: La prévention
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Seul
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
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Comparateur actif: 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
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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.
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Aucune intervention: SRA only
Patients randomized to not get genetic testing will be followed and surveyed and will be counseled based on SRA only
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Aucune intervention: no testing control
Patients not interested in genetic testing will be followed and surveyed.
Counseling will be based on SRA only
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Délai |
|---|---|
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Percentage of weight loss
Délai: 12 months
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12 months
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Mesures de résultats secondaires
Mesure des résultats |
Délai |
|---|---|
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Change in perceptions of personal risk for Type 2 diabetes
Délai: 12 months
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12 months
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Change in HOmeostasis Model Assessment of Insulin Resistance (HOMA-IR)
Délai: 12 months
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12 months
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Collaborateurs et enquêteurs
Parrainer
Collaborateurs
Les enquêteurs
- Chercheur principal: Geoffrey Ginsburg, Md, PhD, Institute for Genome Sciences and Policy, Duke University
- Chercheur principal: Alex Cho, MD, Institute for Genome Sciences and Policy, Duke University
- Chercheur principal: Scott Joy, MD, Duke University
- Chercheur principal: Susanne Haga, PhD, Institute for Genome Sciences and Policy, Duke University
- Chercheur principal: Isaac Lipkus, PhD, Institute for Genome Sciences and Policy, Duke University
- Chercheur principal: Gloria Trujillo, MD, Duke University
- Chercheur principal: Julianne O'Daniel, PhD, Institute for Genome Sciences and Policy, Duke University
Publications et liens utiles
Publications générales
- 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.
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- Pro00011592
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