Long-Term Sequelae of SARS-COV-2 Infection: Diabetes Mellitus

Study Overview
=================
Brief Summary
-----------------
Hospitalized patients with severe COVID-19 have an increased incidence of insulin resistance, impaired beta cell function, glucose intolerance (prediabetes), and overt type 2 diabetes (T2D) compared to non-hospitalized patients with COVID-19 and COVID-19 negative individuals on long-term follow up.

Detailed Description
-----------------
The purpose of this research study is to understand the long-term effects of COVID-19 infection on individuals without any prior history of diabetes. This study will look at several measures of diabetes, such as glycemic control (blood glucose/sugar levels), function of beta cells (cells that make insulin to control sugar), insulin secretion and insulin sensitivity (fasting insulin levels). The following participants will be enrolled: 1) have had COVID-19 infection and were hospitalized and recovered, or 2) have had mild COVID-19 infection and were seen at outpatient clinics or ER and were not required to be hospitalized, or 3) have not had COVID-19 infection but were seen in outpatient clinics or ER during the same time period. The researchers hope to learn the long-term effects of COVID-19 infection in hospitalized patients. Specifically, they will be focusing on the subsequent development of diabetes and associated metabolic disturbances, such as impaired insulin secretion and insulin resistance. A relationship between COVID-19 and diabetes needs to be investigated.

Official Title
-----------------
Long-Term Sequelae of SARS-COV-2 Infection: Diabetes Mellitus

Conditions
-----------------
COVID-19, Diabete Mellitus

Intervention / Treatment
-----------------
* Other: Measure of physiologic parameters


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Body Mass index (BMI) < 40 kg/m2 Exclusion Criteria: History of diabetes prior to SARS-CoV-2 infection Took medications used to treat diabetes prior to SARS-CoV-2 infection History of myocardial infarction or stroke within 6 months History of major organ system disease prior to COVID-19 infection

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
-----------------
All

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Severe COVID-19 Group<br>Hospitalized in ICU with COVID-19 (PCR positive) and recovered | Other: Measure of physiologic parameters<br>* Participants will have hepatic muscle and adipose tissue insulin sensitivity tested<br>|
| Mild COVID-19 positive Group<br>COVID-19 positive (by PCR) who recovered from mild COVID-19 and were seen in outpatient clinics or ER with symptoms that did not justify hospitalization. | Other: Measure of physiologic parameters<br>* Participants will have hepatic muscle and adipose tissue insulin sensitivity tested<br>|
| COVID-19 negative Group<br>COVID-19 negative (by PCR) and seen in outpatient clinics or ER during same time period as Groups I and II. | Other: Measure of physiologic parameters<br>* Participants will have hepatic muscle and adipose tissue insulin sensitivity tested<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measure of glycosylated glucose percentage (HbA1c) | Change in HbA1c, and indication of glucose levels over a 3 month period | Baseline to 24 months | 
| Measure of free plasma glucose (FPG) | Change in FPG | Baseline to 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Body Weight | Change in body weight over the study period | Baseline to 25 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Glycemic control, Long term medical effects of COVID-19, Blood glucose control, Insulin sensitivity