Genetics of Latent Autoimmune Diabetes in Adults

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01793974

Acronym

LADA

Enrollment

205

Registered

2013-02-18

Start date

2011-07-31

Completion date

2017-03-31

Last updated

2017-04-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Latent Autoimmune Diabetes in Adult

Keywords

LADA, Latent Autoimmune Diabetes in Adults, Latent Autoimmune Diabetes, Latent 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.

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.

Interventions

None listed

Study design

Observational model

CASE_CONTROL

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

25 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
Identify variations in the human genome associated with LADA by genotyping cases and comparing allele frequencies to an existing control database	5 years

Secondary

Measure	Time frame
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

Countries

United Kingdom, United States

Outcome results