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Clinical Trials/NCT01793974
NCT01793974
Completed
Not Applicable

A Study of the Genetic Causes of Latent Autoimmune Diabetes in Adults

Children's Hospital of Philadelphia2 sites in 2 countries205 target enrollmentJuly 2011

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Latent Autoimmune Diabetes in Adult
Sponsor
Children's Hospital of Philadelphia
Enrollment
205
Locations
2
Primary Endpoint
Identify variations in the human genome associated with LADA by genotyping cases and comparing allele frequencies to an existing control database
Status
Completed
Last Updated
9 years ago

Overview

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.

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.

Registry
clinicaltrials.gov
Start Date
July 2011
End Date
March 2017
Last Updated
9 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Diagnosed type 2 Diabetes (T2D) patient with: BMI \<30 at diagnosis; Age \>25-\<50 at diagnosis
  • Diagnosed type 1 Diabetes (T1D) patient with: Age \>25 at diagnosis
  • Currently Diagnosed with LADA with age at initial diagnosis of Diabetes \>25 years and a positive GAD65 antibody test

Exclusion Criteria

  • Any underlying disease or condition that is a contraindication for obtaining 18.0 ml of blood.
  • Inability to obtain an informed consent from a given LADA case.
  • Blood sampling has already occurred for a given subject.
  • Previous GAD65 antibody test(s) negative.

Outcomes

Primary Outcomes

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

Secondary Outcomes

  • 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.(5 years)

Study Sites (2)

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