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NCT Number: NCT01793974

Genetics 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.

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Key information

Conditions

Latent Autoimmune Diabetes in Adult Autoimmune Diseases Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases Latent Autoimmune Diabetes in Adults Metabolic Diseases Nutritional and Metabolic Diseases

Age range

25 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

The University of Leicester, Leicester, United Kingdom

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. 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

  1. 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

Sponsors and collaborators

Lead sponsor

Children's Hospital of Philadelphia

Other

Registry information

Official study title

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

Acronym: LADA

Important dates

Study start
2011
Primary completion
2015
Study completion
2017
First posted
Feb 18, 2013
Registry last updated
Apr 13, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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