Genetics of Latent Autoimmune Diabetes in Adults (LADA)

April 12, 2017 updated by: Children's Hospital of Philadelphia

A Study of the Genetic Causes 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.

Study Overview

Status

Completed

Conditions

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.

Study Type

Observational

Enrollment (Actual)

205

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • Leicester, United Kingdom
        • The University of Leicester
  • United States
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • The Children's Hospital of Philadelphia

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

The recruitment will be carried out at several adult diabetes clinics across the United States.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
5 years

Secondary Outcome Measures

Outcome Measure
Time Frame
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
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Children's Hospital of Philadelphia

Investigators

  • Principal Investigator: Struan Grant, Ph.D., Children's Hospital of Philadelphia

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2011

Primary Completion (Actual)

November 1, 2015

Study Completion (Actual)

March 1, 2017

Study Registration Dates

First Submitted

February 4, 2013

First Submitted That Met QC Criteria

February 14, 2013

First Posted (Estimate)

February 18, 2013

Study Record Updates

Last Update Posted (Actual)

April 13, 2017

Last Update Submitted That Met QC Criteria

April 12, 2017

Last Verified

April 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 11-008065

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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