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

NCT ID: NCT05553145

Last Updated: 2025-01-10

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 200 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-09-01
• Study Completion Date: 2024-08-29

Brief Summary

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.

Conditions

Type 2 Diabetes

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

Patients Seen by their Endocrinologist

Patients whose diabetes is managed by their Endocrinologist

Autoimmune Antibody Assays

Intervention Type: DIAGNOSTIC_TEST

GAD-65, Islet cell-Ab, IA-2 Ab, anti-insulin Ab, and ZnTn8 Ab

Patients Seen by their Primary Care Provider

Patients whose diabetes is managed by their Primary Care Provider

Autoimmune Antibody Assays

Intervention Type: DIAGNOSTIC_TEST

GAD-65, Islet cell-Ab, IA-2 Ab, anti-insulin Ab, and ZnTn8 Ab

Interventions

Autoimmune Antibody Assays

GAD-65, Islet cell-Ab, IA-2 Ab, anti-insulin Ab, and ZnTn8 Ab

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Cleveland Clinic

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kevin Pantalone, DO

Role: PRINCIPAL_INVESTIGATOR

The Cleveland Clinic

Locations

Twinsburg Family Health & Surgery Center

Twinsburg, Ohio, United States

Countries

United States

Other Identifiers

22-797

Identifier Type: -

Identifier Source: org_study_id