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
  Purpose

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
Latent Autoimmune Diabetes in Adult

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: A Study of the Genetic Causes of Latent Autoimmune Diabetes in Adults

Resource links provided by NLM:


Further study details as provided by Children's Hospital of Philadelphia:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Biospecimen Retention:   Samples With DNA

Whole blood, plasma, serum


Estimated Enrollment: 10000
Study Start Date: July 2011
Estimated Study Completion Date: March 2017
Estimated Primary Completion Date: March 2017 (Final data collection date for primary outcome measure)
Groups/Cohorts
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

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.

  Eligibility

Ages Eligible for Study:   25 Years and older
Genders Eligible for Study:   Both
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.

Criteria

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.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01793974

Contacts
Contact: Vanessa Guy, M.S. 215-590-6815 guyv@email.chop.edu

Locations
United States, Pennsylvania
The Children's Hospital of Philadelphia Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Vanessa Guy, M.S.    215-590-6815    guyv@email.chop.edu   
Principal Investigator: Struan Grant, Ph.D.         
Sponsors and Collaborators
Children's Hospital of Philadelphia
Investigators
Principal Investigator: Struan Grant, Ph.D. Children's Hospital of Philadelphia
  More Information

No publications provided

Responsible Party: Children's Hospital of Philadelphia
ClinicalTrials.gov Identifier: NCT01793974     History of Changes
Other Study ID Numbers: 11-008065
Study First Received: February 4, 2013
Last Updated: May 2, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Children's Hospital of Philadelphia:
LADA
Latent Autoimmune Diabetes in Adults
Latent Autoimmune Diabetes
Latent Diabetes in Adults

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on August 26, 2014