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

NCT05553145 | Completed

• 1 other identifier: 22-797
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Type 2 Diabetes

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Prevalence of autoimmune antibodies in patients with T2D managed by endocrinology

  One-time blood draw at consent/screening

• Prevalence of autoimmune antibodies in patients with T2D managed by primary care

  One-time blood draw at consent/screening

Study Arms (2)

Patients Seen by their Endocrinologist

Patients whose diabetes is managed by their Endocrinologist

Diagnostic Test: Autoimmune Antibody Assays

Patients Seen by their Primary Care Provider

Patients whose diabetes is managed by their Primary Care Provider

Diagnostic Test: Autoimmune Antibody Assays

Interventions

Autoimmune Antibody Assays DIAGNOSTIC_TEST

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

Patients Seen by their Endocrinologist; Patients Seen by their Primary Care Provider

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Participants will be recruited from community hospital either coming in to see their primary care physician or endocrinologist.

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• The Cleveland Clinic: lead

Study Sites (1)

Twinsburg Family Health & Surgery Center

Twinsburg, Ohio, 44087, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Kevin Pantalone, DO

  The Cleveland Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 21, 2022
• First Posted: September 23, 2022
• Study Start: September 1, 2022
• Primary Completion: May 31, 2023
• Study Completion: August 29, 2024
• Last Updated: January 10, 2025

Record last verified: 2024-10

Locations

US (1)