Genetics of Latent Autoimmune Diabetes in Adults (LADA)

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by Children's Hospital of Philadelphia
Sponsor:
Information provided by (Responsible Party):
Children's Hospital of Philadelphia
ClinicalTrials.gov Identifier:
NCT01793974
First received: February 4, 2013
Last updated: May 2, 2014
Last verified: May 2014

February 4, 2013
May 2, 2014
July 2011
March 2017   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01793974 on ClinicalTrials.gov Archive Site
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. [ Time Frame: 5 years ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Genetics of Latent Autoimmune Diabetes in Adults
A Study of the Genetic Causes of Latent Autoimmune Diabetes in Adults

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.

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.

Observational
Observational Model: Case Control
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:

Whole blood, plasma, serum

Non-Probability Sample

The recruitment will be carried out at several adult diabetes clinics across the United States.

Latent Autoimmune Diabetes in Adult
Not Provided
  • Latent Autoimmune Diabetes in Adult
    Individuals who meet criteria for Latent Autoimmune Diabetes in Adult
  • Without Latent Autoimmune Diabetes in Adult
    Individuals who do not meet criteria for Latent Autoimmune Diabetes in Adult
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
10000
March 2017
March 2017   (final data collection date for primary outcome measure)

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.
Both
25 Years and older
No
Contact: Vanessa Guy, M.S. 215-590-6815 guyv@email.chop.edu
United States
 
NCT01793974
11-008065
No
Children's Hospital of Philadelphia
Children's Hospital of Philadelphia
Not Provided
Principal Investigator: Struan Grant, Ph.D. Children's Hospital of Philadelphia
Children's Hospital of Philadelphia
May 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP