Latent Autoimmune Diabetes in AdultLADANCT01793974
Genetics of Latent Autoimmune Diabetes in Adults
An observational study of Latent Autoimmune Diabetes in Adult, run by Children's Hospital of Philadelphia at 2 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 25 years and older
- Conditions the study is for
- Latent Autoimmune Diabetes in Adult
- How many people
- 205 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Jul 2011to Mar 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The recruitment will be carried out at several adult diabetes clinics across the United States.
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
United States1 site
The Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
About this study
Official title: 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.
Read the 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.
- Conditions
- Latent Autoimmune Diabetes in Adult
- Keywords
- LADA, Latent Autoimmune Diabetes in Adults, Latent Autoimmune Diabetes, Latent Diabetes in Adults
- Medical subject headings
- Latent Autoimmune Diabetes in Adults
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Identify variations in the human genome associated with LADA by genotyping cases and comparing allele frequencies to an existing control database
Measured: 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.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2013 (estimated)
- Study startJul 2011
- Primary completionNov 2015
- Study completionMar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Latent Autoimmune Diabetes in AdultStudies of the same condition, open and under way.
- More trials run by Children's Hospital of PhiladelphiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 205 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital of Philadelphia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Struan Grant, Ph.D., Principal investigator, Children's Hospital of Philadelphia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01793974
- Sponsor's protocol ID
- 11-008065
- Acronym
- LADA
- Status last verified
- Apr 2017
- First submitted
- 4 Feb 2013
- Last updated
- 13 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study of the Genetic Causes of Latent Autoimmune Diabetes in Adults
- ClinicalTrials.gov ID
- NCT01793974
- Acronym / sponsor ID
- LADA / 11-008065
- Conditions
- Latent Autoimmune Diabetes in Adult
- Keywords
- LADA, Latent Autoimmune Diabetes in Adults, Latent Autoimmune Diabetes, Latent Diabetes in Adults
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 205 participants (actual)
- Lead sponsor
- Children's Hospital of PhiladelphiaUniversity, hospital or other
- Study start
- Jul 2011
- Primary completion
- Nov 2015 (actual)
- Study completion
- Mar 2017 (actual)
- First posted
- 18 Feb 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 25 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The recruitment will be carried out at several adult diabetes clinics across the United States.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Struan Grant, Ph.D. principal investigator
Children's Hospital of Philadelphia
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Latent Autoimmune Diabetes in Adult, run by Children's Hospital of Philadelphia at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2017.