Genetics of Latent Autoimmune Diabetes in Adults

NCT ID: NCT01793974

Last Updated: 2017-04-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

205 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-07-31

Study Completion Date

2017-03-31

Brief Summary

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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

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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.

Conditions

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Latent Autoimmune Diabetes in Adult

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Latent Autoimmune Diabetes in Adult

Individuals who meet criteria for Latent Autoimmune Diabetes in Adult

No interventions assigned to this group

Without Latent Autoimmune Diabetes in Adult

Individuals who do not meet criteria for Latent Autoimmune Diabetes in Adult

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Diagnosed type 2 Diabetes (T2D) patient with: BMI \<30 at diagnosis; Age \>25-\<50 at diagnosis

OR

* Diagnosed type 1 Diabetes (T1D) patient with: Age \>25 at diagnosis

OR

\- 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.
Minimum Eligible Age

25 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Children's Hospital of Philadelphia

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Struan Grant, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Children's Hospital of Philadelphia

Locations

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The Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, United States

Site Status

The University of Leicester

Leicester, , United Kingdom

Site Status

Countries

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United States United Kingdom

Other Identifiers

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11-008065

Identifier Type: -

Identifier Source: org_study_id

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