Genetics of Latent Autoimmune Diabetes in Adults

Latent Autoimmune Diabetes in Adult Clinical Trial

— LADA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01793974
• Other study ID #: 11-008065
• Status: Completed
• Phase: N/A
• First received: February 4, 2013
• Last updated: April 12, 2017
• Start date: July 2011
• Est. completion date: March 2017

Study information

• Verified date: April 2017
• Source: Children's Hospital of Philadelphia
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 205
• Est. completion date: March 2017
• Est. primary completion date: November 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 25 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Latent Autoimmune Diabetes in Adult

Locations

Country	Name	City	State
United Kingdom	The University of Leicester	Leicester
United States	The Children's Hospital of Philadelphia	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Children's Hospital of Philadelphia

Countries where clinical trial is conducted

United States,  United Kingdom, 

Outcome

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