Clinical trial NCT05553145: The Prevalence of Autoimmune Antibodies in Patients with Type 2 Diabetes Managed by Endocrinology Vs. Primary Care
Official title: The Prevalence of Autoimmune Antibodies in Patients with Type 2 Diabetes Managed by Endocrinology Vs. Primary Care
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Type 2 Diabetes
Lead sponsor: The Cleveland Clinic
Sponsor class: OTHER
First posted: 2022-09-23
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
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.

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.

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)

Primary outcomes:
measure: Prevalence of autoimmune antibodies in patients with Type 2 Diabetes
timeFrame: One-time blood draw at consent/screening
Secondary outcomes:
measure: Prevalence of autoimmune antibodies in patients with T2D managed by endocrinology
timeFrame: One-time blood draw at consent/screening
measure: Prevalence of autoimmune antibodies in patients with T2D managed by primary care
timeFrame: One-time blood draw at consent/screening
Other outcomes:
Locations:
city: Twinsburg
country: United States
facility: Twinsburg Family Health & Surgery Center
state: Ohio
Study officials:
affiliation: The Cleveland Clinic
name: Kevin Pantalone, DO
role: PRINCIPAL_INVESTIGATOR
References: