Autoimmune DiabetesNCT01148238
Autoimmune Diabetes: Markers of the Disease and Treatment of Latent Autoimmune Diabetes in Adults (LADA)
An observational study of Autoimmune Diabetes, run by Norwegian University of Science and Technology.
Trial summary
Autoimmunity is the main cause of diabetes type 1 and an important factor as cause of Latent Autoimmune Diabetes in Adults (LADA). Recently, research has found that being deficient of T-reg cells is an important cause of autoimmunity. The study hypothesis are: 1. Read more about this study
- Who is it for?
- Ages 30 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Autoimmune Diabetes
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Aug 2012to Dec 2012
- 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 30 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: 10 patients with newly diagnosed diabetes type 1. 10 healthy age- and sex matched blood donors. 10 patients with LADA. 10 healthy age- and sex matched blood donors. 10 patients with diabetes type 1 older than 10 years. 10 healthy age- and sex matched blood donors.
Who may be able to join
- newly diagnosed diabetes type 1
- LADA
- diabetes type 1 older than 10 years
Who cannot join
- none
About this study
Official title: Autoimmune Diabetes: Disease Markers and Treatment of Latent Autoimmune Diabetes in Adults (LADA)
Autoimmunity is the main cause of diabetes type 1 and an important factor as cause of Latent Autoimmune Diabetes in Adults (LADA). Recently, research has found that being deficient of T-reg cells is an important cause of autoimmunity. The study hypothesis are:
- Patients with newly found diabetes type 1 have less T-reg than healthy.
- Patients with newly found diabetes type 1 have less T-reg than patients with long duration of the illness.
- The number of T-reg is negative associated with HLA-risk-haplotype.
- The number of T-reg is negative associated with LADA.
- Differences relating to inflammatory cytokines will be seen among patients with newly found diabetes type 1, but not among others.
Read the detailed description
Research has worked out that b-cells are being destroyed by cytokines released from inflammatory cells. One hypothesis in that T-reg is a cause of autoimmunity, and that T-reg concentrations are low in patients with newly diagnosed diabetes type 1.
Blood samples will be taken from 10 patients with newly diagnosed type 1 diabetes, Latent Autoimmune Diabetes in Adults (LADA) and type 1 diabetes older than 10 years and the same amount of samples from healthy, age- and sex-matched blood donors. Markers of autoimmune diabetes will be analyzed.
- Conditions
- Autoimmune Diabetes
- Keywords
- Autoimmune diabetes, LADA, T-reg, cytokine
- Medical subject headings
- Diabetes Mellitus, Type 1
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 |
|---|---|---|
| Diabetes type 1 older than 10 years | Blood samples will be taken from 10 patients with diabetes type 1 older than 10 years and 10 healthy age-and sexmatched controls. | |
| Newly diagnosed type 1 diabetes | Blood samples will be taken from 10 patients with newly diagnosed type 1 diabetes and 10 healthy age-and sexmatched controls. | |
| LADA | Blood samples will be taken from 10 patients with LADA and 10 healthy age-and sexmatched controls. |
What is being measured
The primary outcome is the main question the study is designed to answer.
T-reg
Secondary outcomes (1)
HLA, anti-GAD, anti-IA2, white blood count, CRP, fasting C-peptide, HbA1c
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2010 (estimated)
- Study startAug 2012
- Primary completionDec 2012
- Study completionDec 2012
Why it stopped: changed research plan
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autoimmune DiabetesStudies of the same condition, open and under way.
- More trials run by Norwegian University of Science and TechnologyThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Norwegian University of Science and Technology
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Valdemar Grill, M.D, PhD, Principal investigator, Department of Cancer Research and Molecular Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01148238
- Sponsor's protocol ID
- AUTO
- Status last verified
- Dec 2012
- First submitted
- 17 Jun 2010
- Last updated
- 10 Dec 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Autoimmune Diabetes: Disease Markers and Treatment of Latent Autoimmune Diabetes in Adults (LADA)
- ClinicalTrials.gov ID
- NCT01148238
- Acronym / sponsor ID
- AUTO
- Conditions
- Autoimmune Diabetes
- Keywords
- Autoimmune diabetes, LADA, T-reg, cytokine
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: changed research plan
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Norwegian University of Science and TechnologyUniversity, hospital or other
- Study start
- Aug 2012
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 22 Jun 2010 (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.
Autoimmunity is the main cause of diabetes type 1 and an important factor as cause of Latent Autoimmune Diabetes in Adults (LADA). Recently, research has found that being deficient of T-reg cells is an important cause of autoimmunity. The study hypothesis are:
- Patients with newly found diabetes type 1 have less T-reg than healthy.
- Patients with newly found diabetes type 1 have less T-reg than patients with long duration of the illness.
- The number of T-reg is negative associated with HLA-risk-haplotype.
- The number of T-reg is negative associated with LADA.
- Differences relating to inflammatory cytokines will be seen among patients with newly found diabetes type 1, but not among others.
Detailed description
Research has worked out that b-cells are being destroyed by cytokines released from inflammatory cells. One hypothesis in that T-reg is a cause of autoimmunity, and that T-reg concentrations are low in patients with newly diagnosed diabetes type 1.
Blood samples will be taken from 10 patients with newly diagnosed type 1 diabetes, Latent Autoimmune Diabetes in Adults (LADA) and type 1 diabetes older than 10 years and the same amount of samples from healthy, age- and sex-matched blood donors. Markers of autoimmune diabetes will be analyzed.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Diabetes type 1 older than 10 years | – | –Blood samples will be taken from 10 patients with diabetes type 1 older than 10 years and 10 healthy age-and sexmatched controls. |
| Newly diagnosed type 1 diabetes | – | –Blood samples will be taken from 10 patients with newly diagnosed type 1 diabetes and 10 healthy age-and sexmatched controls. |
| LADA | – | –Blood samples will be taken from 10 patients with LADA and 10 healthy age-and sexmatched controls. |
Who may qualify
- Ages
- 30 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 10 patients with newly diagnosed diabetes type 1. 10 healthy age- and sex matched blood donors. 10 patients with LADA. 10 healthy age- and sex matched blood donors. 10 patients with diabetes type 1 older than 10 years. 10 healthy age- and sex matched blood donors.
Key inclusion criteria (3 listed)
- newly diagnosed diabetes type 1
- LADA
- diabetes type 1 older than 10 years
Key exclusion criteria (1 listed)
- none
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
T-reg
1 secondary outcome
HLA, anti-GAD, anti-IA2, white blood count, CRP, fasting C-peptide, HbA1c
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2012.
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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.
Valdemar Grill, M.D, PhD principal investigator
Department of Cancer Research and Molecular Medicine
Questions about this trial
What is this clinical trial studying?
An observational study of Autoimmune Diabetes, run by Norwegian University of Science and Technology.
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 3 inclusion and 1 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: withdrawn, as of the sponsor's last update on 10 Dec 2012. Status can change between updates, so confirm with the study contact before making plans.
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 was withdrawn before enrolling participants, so there are no results.
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?
T-reg. 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 10 Dec 2012.