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Genetics of Latent Autoimmune Diabetes in Adults (LADA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01793974
Recruitment Status : Completed
First Posted : February 18, 2013
Last Update Posted : April 13, 2017
Information provided by (Responsible Party):
Children's Hospital of Philadelphia

Brief 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.

Condition or disease
Latent Autoimmune Diabetes in Adult

Detailed 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.

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Study Type : Observational
Actual Enrollment : 205 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: A Study of the Genetic Causes of Latent Autoimmune Diabetes in Adults
Study Start Date : July 2011
Actual Primary Completion Date : November 2015
Actual Study Completion Date : March 2017

Resource links provided by the National Library of Medicine

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

Primary Outcome Measures :
  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 Outcome Measures :
  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 ]

Biospecimen Retention:   Samples With DNA
Whole blood, plasma, serum

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   25 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
The recruitment will be carried out at several adult diabetes clinics across the United States.

Inclusion Criteria:

  • Diagnosed type 2 Diabetes (T2D) patient with: BMI <30 at diagnosis; Age >25-<50 at diagnosis


  • Diagnosed type 1 Diabetes (T1D) patient with: Age >25 at diagnosis


- 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01793974

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United States, Pennsylvania
The Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19104
United Kingdom
The University of Leicester
Leicester, United Kingdom
Sponsors and Collaborators
Children's Hospital of Philadelphia
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Principal Investigator: Struan Grant, Ph.D. Children's Hospital of Philadelphia
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Responsible Party: Children's Hospital of Philadelphia Identifier: NCT01793974    
Other Study ID Numbers: 11-008065
First Posted: February 18, 2013    Key Record Dates
Last Update Posted: April 13, 2017
Last Verified: April 2017
Keywords provided by Children's Hospital of Philadelphia:
Latent Autoimmune Diabetes in Adults
Latent Autoimmune Diabetes
Latent Diabetes in Adults
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 1
Latent Autoimmune Diabetes in Adults
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases