Overview

This trial is active, not recruiting.

Condition latent autoimmune diabetes in adult
Sponsor Children's Hospital of Philadelphia
Start date July 2011
End date November 2015
Trial size 205 participants
Trial identifier NCT01793974, 11-008065

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model case control
Time perspective prospective
Arm
Individuals who meet criteria for Latent Autoimmune Diabetes in Adult
Individuals who do not meet criteria for Latent Autoimmune Diabetes in Adult

Primary Outcomes

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

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.
time frame: 5 years

Eligibility Criteria

Male or female participants at least 25 years old.

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.

Additional Information

Official title A Study of the Genetic Causes of Latent Autoimmune Diabetes in Adults
Principal investigator Struan Grant, Ph.D.
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.
Trial information was received from ClinicalTrials.gov and was last updated in April 2016.
Information provided to ClinicalTrials.gov by Children's Hospital of Philadelphia.