The Prevalence of Autoimmune Antibodies in Patients With Type 2 Diabetes Managed by Endocrinology vs. Primary Care

Type 2 Diabetes Clinical Trial

Official title:

The Prevalence of Autoimmune Antibodies in Patients With Type 2 Diabetes Managed by Endocrinology vs. Primary Care

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05553145
• Other study ID #: 22-797
• Status: Active, not recruiting
• Start date: September 1, 2022
• Est. completion date: August 29, 2024

Study information

• Verified date: June 2024
• Source: The Cleveland Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 200
• Est. completion date: August 29, 2024
• Est. primary completion date: May 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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)

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes

Intervention

Diagnostic Test:
• Autoimmune Antibody Assays
GAD-65, Islet cell-Ab, IA-2 Ab, anti-insulin Ab, and ZnTn8 Ab

Locations

Country	Name	City	State
United States	Twinsburg Family Health & Surgery Center	Twinsburg	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
The Cleveland Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	One-time blood draw at consent/screening
Secondary	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	One-time blood draw at consent/screening
Secondary	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	One-time blood draw at consent/screening