Type 2 DiabetesNCT05553145
The Prevalence of Autoimmune Antibodies in Patients with Type 2 Diabetes Managed by Endocrinology Vs. Primary Care
An observational study of Type 2 Diabetes, run by The Cleveland Clinic at 1 site in United States.
Trial summary
The purpose of this study is to assess the levels of autoimmune markers of diabetes in those with a type 2 diabetes diagnosis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- Autoimmune Antibody Assays
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2022to 29 Aug 2024
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Participants will be recruited from community hospital either coming in to see their primary care physician or endocrinologist.
Who may be able to join
- Language: English
- Age: ≥ 18
- Type 2 diabetes
- Ability to provide informed consent before any trial-related activities. Trial-related activities are any procedure that would not have been performed during normal management of the subject.
Who cannot join
- Patients with a diagnosis of T1D or LADA in their problem list
- Patients with an encounter diagnosis for T1D or LADA
- Mental incapacity or language barrier (non-English speaking)
Trial locations and contacts
1 site in 1 country.
United States1 site
Twinsburg Family Health & Surgery Center
Twinsburg, Ohio, 44087
About this study
The purpose of this study is to assess the levels of autoimmune markers of diabetes in those with a type 2 diabetes diagnosis.
Read the detailed description
Autoimmune markers can appear when the body uses its natural defense system to mistakenly attack the patient's own cells because it cannot tell the difference between the patient and foreign cells. The study investigators want to determine if there are any differences in these marker levels when comparing patients who are managed by their primary care provider and patients managed by endocrinology. Patients will be asked to come in for a blood draw. This sample will be used for autoimmune antibody testing. An antibody is a protein in the blood that is made to find and respond to a specific antigen. An antigen is something that triggers the body to have an immune response. Patient participation in the research study will last for the duration of one visit to the clinic for informed consent and a blood draw.
The clinical implications of detecting this type of diabetes can be profound, as it can identify patients who are at risk of becoming insulin dependent in the near future, and therefore may require a change in diabetes management to avoid adverse outcomes. In addition, identifying these patients may also open up the door for treatments directed at stopping the complete autoimmune destruction of insulin producing cells, potentially delaying or avoiding the need for insulin dependency.
The study team presumes that autoimmune markers of diabetes will be detected in patients with a diagnosis of type 2 diabetes and the prevalence of these markers will be higher among patients managed by endocrinology. The population of patients found to have detectable autoimmune markers of diabetes will differ from the population of patients without these markers. The population of patients managed by endocrinology that are found to have detectable autoimmune markers of diabetes will differ from the population of patients managed by primary care. The population of patients with more than 1 autoimmune antibody are more likely to require insulin therapy.
- Conditions
- Type 2 Diabetes
- Being tested
- Autoimmune Antibody Assays
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Autoimmune Antibody AssaysDiagnostic test
GAD-65, Islet cell-Ab, IA-2 Ab, anti-insulin Ab, and ZnTn8 Ab
| Study group | Role | What they receive |
|---|---|---|
| Patients Seen by their Endocrinologist | Patients whose diabetes is managed by their Endocrinologist Receives: Diagnostic Test: Autoimmune Antibody Assays | |
| Patients Seen by their Primary Care Provider | Patients whose diabetes is managed by their Primary Care Provider Receives: Diagnostic Test: Autoimmune Antibody Assays |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of autoimmune antibodies in patients with Type 2 Diabetes
Percentage of subjects with T2D and detectable autoimmune antibodies calculated as the percentage of subjects that test positive for at least one of the autoimmune antibodies
Measured: One-time blood draw at consent/screening
Secondary outcomes (2)
Prevalence of autoimmune antibodies in patients with T2D managed by endocrinology
Percentage of subjects whose diabetes is managed by an endocrinologist with T2D and detectable autoimmune antibodies calculated as the percentage of subjects that test positive for at least one of the autoimmune antibodies
Measured: One-time blood draw at consent/screening
Prevalence of autoimmune antibodies in patients with T2D managed by primary care
Percentage of subjects whose diabetes is managed by a primacy care physician with T2D and detectable autoimmune antibodies calculated as the percentage of subjects that test positive for at least one of the autoimmune antibodies
Measured: One-time blood draw at consent/screening
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2022
- Study start1 Sep 2022
- Primary completion31 May 2023
- Study completion29 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- More trials run by The Cleveland ClinicThe 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
- Cross-sectional
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Cleveland Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kevin Pantalone, DO, Principal investigator, The Cleveland Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05553145
- Sponsor's protocol ID
- 22-797
- Status last verified
- Oct 2024
- First submitted
- 21 Sep 2022
- Last updated
- 10 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Prevalence of Autoimmune Antibodies in Patients with Type 2 Diabetes Managed by Endocrinology Vs. Primary Care
- ClinicalTrials.gov ID
- NCT05553145
- Acronym / sponsor ID
- 22-797
- Conditions
- Type 2 Diabetes
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- The Cleveland ClinicUniversity, hospital or other
- Study start
- 1 Sep 2022 (actual)
- Primary completion
- 31 May 2023 (actual)
- Study completion
- 29 Aug 2024 (actual)
- First posted
- 23 Sep 2022 (actual)
- 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.
The purpose of this study is to assess the levels of autoimmune markers of diabetes in those with a type 2 diabetes diagnosis.
Detailed description
Autoimmune markers can appear when the body uses its natural defense system to mistakenly attack the patient's own cells because it cannot tell the difference between the patient and foreign cells. The study investigators want to determine if there are any differences in these marker levels when comparing patients who are managed by their primary care provider and patients managed by endocrinology. Patients will be asked to come in for a blood draw. This sample will be used for autoimmune antibody testing. An antibody is a protein in the blood that is made to find and respond to a specific antigen. An antigen is something that triggers the body to have an immune response. Patient participation in the research study will last for the duration of one visit to the clinic for informed consent and a blood draw.
The clinical implications of detecting this type of diabetes can be profound, as it can identify patients who are at risk of becoming insulin dependent in the near future, and therefore may require a change in diabetes management to avoid adverse outcomes. In addition, identifying these patients may also open up the door for treatments directed at stopping the complete autoimmune destruction of insulin producing cells, potentially delaying or avoiding the need for insulin dependency.
The study team presumes that autoimmune markers of diabetes will be detected in patients with a diagnosis of type 2 diabetes and the prevalence of these markers will be higher among patients managed by endocrinology. The population of patients found to have detectable autoimmune markers of diabetes will differ from the population of patients without these markers. The population of patients managed by endocrinology that are found to have detectable autoimmune markers of diabetes will differ from the population of patients managed by primary care. The population of patients with more than 1 autoimmune antibody are more likely to require insulin therapy.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients Seen by their Endocrinologist | – | Diagnostic Test: Autoimmune Antibody AssaysPatients whose diabetes is managed by their Endocrinologist |
| Patients Seen by their Primary Care Provider | – | Diagnostic Test: Autoimmune Antibody AssaysPatients whose diabetes is managed by their Primary Care Provider |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants will be recruited from community hospital either coming in to see their primary care physician or endocrinologist.
Key inclusion criteria (4 listed)
- Language: English
- Age: ≥ 18
- Type 2 diabetes
- Ability to provide informed consent before any trial-related activities. Trial-related activities are any procedure that would not have been performed during normal management of the subject.
Key exclusion criteria (3 listed)
- Patients with a diagnosis of T1D or LADA in their problem list
- Patients with an encounter diagnosis for T1D or LADA
- Mental incapacity or language barrier (non-English speaking)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Autoimmune Antibody AssaysGAD-65, Islet cell-Ab, IA-2 Ab, anti-insulin Ab, and ZnTn8 Ab | Diagnostic test | Patients Seen by their Endocrinologist, Patients Seen by their Primary Care Provider |
Primary outcome
Prevalence of autoimmune antibodies in patients with Type 2 Diabetes
Time frame: One-time blood draw at consent/screening
Percentage of subjects with T2D and detectable autoimmune antibodies calculated as the percentage of subjects that test positive for at least one of the autoimmune antibodies
2 secondary outcomes
Prevalence of autoimmune antibodies in patients with T2D managed by endocrinology
Time frame: One-time blood draw at consent/screening
Prevalence of autoimmune antibodies in patients with T2D managed by primary care
Time frame: One-time blood draw at consent/screening
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 10 Jan 2025.
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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.
Kevin Pantalone, DO principal investigator
The Cleveland Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Type 2 Diabetes, run by The Cleveland Clinic at 1 site in United States.
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 4 inclusion and 3 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 10 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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?
Prevalence of autoimmune antibodies in patients with Type 2 Diabetes (time frame: One-time blood draw at consent/screening). 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 Jan 2025.