Genetics of Latent Autoimmune Diabetes in Adults

  • Clinical Studies
  • Leicester

NIHR

clinical trials leicester, clinical research uk,

Primary Trial ID Number

NCT01793974

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.
Research Details
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.

Study Design
Observational Model: Case Control, Time Perspective: Prospective
Study Type
Observational
Intervention
Sorry, this information is not available
Intervention Type
See Interventions above
Primary Outcome Measures
Identify variations in the human genome associated with LADA by genotyping cases and comparing allele frequencies to an existing control database; 5 years
Secondary Outcome Measures
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

Result Reports
This is available on the Clinicaltrials.gov website
Key Dates

Recruitment Start Date
Jul 2011
Recruitment End Date
Mar 2017

Trial End Date
Date Not Available
Date Assigned
04 Feb 2013
Last Updated
08 Oct 2015

Gender
Both
Age Range
25 Years – N/A
Who Can Participate
Patients
Number of Participants
10000
Participant Inclusion 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.
Participant Exclusion Criteria
This is in the inclusion criteria above

Trial Location(s)
Leicester
Trial Contact(s)
Primary Trial Contact
Kenyaita M Hodge, MPH
hodgek@email.chop.edu
215-590-6815
Other Trial Contacts
Sorry, this information is not available
Countries Recruiting
United Kingdom, United States

Scientific Title
A Study of the Genetic Causes of Latent Autoimmune Diabetes in Adults
EudraCT Number
Not available for this trial
Funder(s)
Sorry, this information is not available
Other Study ID Numbers
11-008065
Sponsor(s)
Children’s Hospital of Philadelphia

To apply for this job please visit the following URL: http://www.ukctg.nihr.ac.uk/trials/trial-details/trial-details?trialId=16279 →