Genetics of Latent Autoimmune Diabetes in Adults (LADA)
| Tracking Information | |||||
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| First Received Date ICMJE | February 4, 2013 | ||||
| Last Updated Date | February 14, 2013 | ||||
| Start Date ICMJE | July 2011 | ||||
| Estimated Primary Completion Date | March 2017 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Identify variations in the human genome associated with LADA by genotyping cases and comparing allele frequencies to an existing control database [ Time Frame: 5 years ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT01793974 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
Identify associations between genetic variants with certain measurable risk profiles that can be used to judge the health status or well being of a LADA case. [ Time Frame: 5 years ] [ Designated as safety issue: No ] | ||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Genetics of Latent Autoimmune Diabetes in Adults | ||||
| Official Title ICMJE | A Study of the Genetic Causes of Latent Autoimmune Diabetes in Adults | ||||
| Brief Summary | This is a prospective study that will study adults and has the objective of examining 'Latent Autoimmune Diabetes in Adults' (LADA) to understand how this trait is influenced by genetic factors. |
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| Detailed Description | A case-control study approach will be used to compare the allelic frequencies of Deoxyribonucleic acid (DNA) markers of the cases (i.e., LADA patients) to a randomly selected control samples that does not have the trait under study. To study the role of genetic factors in LADA, the study seeks to determine if certain genomic regions that are captured or mirrored by selective Single nucleotide polymorphisms (SNPs) that are genotyped, are over or underrepresented in those with the disease compared to those who do not. The level of auto-antibodies is the serum can also be studied as a quantitative trait where we ask the question if there is correlation with specific SNP alleles that are genotyped. The markers that are found to be over or under-represented in the study cases will then be tested in an independent set of patients also recruited in this study. This allows us to filter markers that show significance simply by chance and prevents us from being misled. |
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| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Observational Model: Case Control Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Retention: Samples With DNA Description: Whole blood, plasma, serum |
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| Sampling Method | Non-Probability Sample | ||||
| Study Population | The recruitment will be carried out at several adult diabetes clinics across the United States. |
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| Condition ICMJE | Latent Autoimmune Diabetes in Adult | ||||
| Intervention ICMJE | Not Provided | ||||
| Study Group/Cohort (s) |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Recruiting | ||||
| Estimated Enrollment ICMJE | 10000 | ||||
| Estimated Completion Date | March 2017 | ||||
| Estimated Primary Completion Date | March 2017 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
OR
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 25 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE |
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| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01793974 | ||||
| Other Study ID Numbers ICMJE | 11-008065 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Children's Hospital of Philadelphia | ||||
| Study Sponsor ICMJE | Children's Hospital of Philadelphia | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | Children's Hospital of Philadelphia | ||||
| Verification Date | February 2013 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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