Clinical trial NCT01793974: Genetics of Latent Autoimmune Diabetes in Adults
Official title: A Study of the Genetic Causes of Latent Autoimmune Diabetes in Adults
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Latent Autoimmune Diabetes in Adult
Keywords: LADA
Latent Autoimmune Diabetes in Adults
Latent Autoimmune Diabetes
Latent Diabetes in Adults
Lead sponsor: Children's Hospital of Philadelphia
Sponsor class: OTHER
First posted: 2013-02-18
Enrollment: 205
Sex: ALL
Minimum age (years): 25
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The recruitment will be carried out at several adult diabetes clinics across the United States.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Identify variations in the human genome associated with LADA by genotyping cases and comparing allele frequencies to an existing control database
timeFrame: 5 years
Secondary outcomes:
measure: 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.
timeFrame: 5 years
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: The Children's Hospital of Philadelphia
state: Pennsylvania
city: Leicester
country: United Kingdom
facility: The University of Leicester
Study officials:
affiliation: Children's Hospital of Philadelphia
name: Struan Grant, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: