Long-Term Sequelae of SARS-COV-2 Infection: Diabetes Mellitus
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Severe COVID-19 Group Hospitalized in ICU with COVID-19 (PCR positive) and recovered |
Other: Measure of physiologic parameters
Participants will have hepatic muscle and adipose tissue insulin sensitivity tested
|
| Mild COVID-19 positive Group 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
Participants will have hepatic muscle and adipose tissue insulin sensitivity tested
|
| COVID-19 negative Group 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
Participants will have hepatic muscle and adipose tissue insulin sensitivity tested
|
Outcome Measures
Primary Outcome Measures
- Measure of glycosylated glucose percentage (HbA1c) [Baseline to 24 months]
Change in HbA1c, and indication of glucose levels over a 3 month period
- Measure of free plasma glucose (FPG) [Baseline to 24 months]
Change in FPG
Secondary Outcome Measures
- Body Weight [Baseline to 25 months]
Change in body weight over the study period
Eligibility Criteria
Criteria
Inclusion Criteria:
- Body Mass index (BMI) < 40 kg/m2
Exclusion Criteria:
-
History of diabetes prior to SARS-CoV-2 infection
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Took medications used to treat diabetes prior to SARS-CoV-2 infection
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History of myocardial infarction or stroke within 6 months
-
History of major organ system disease prior to COVID-19 infection
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Texas Diabetes Institute - University Health System | San Antonio | Texas | United States | 78207 |
Sponsors and Collaborators
- The University of Texas Health Science Center at San Antonio
- National Heart, Lung, and Blood Institute (NHLBI)
Investigators
- Principal Investigator: Ralph DeFronzo, MD, University of Texas Health Science Center San Antonio
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- HSC20220656H
- OT2HL161847-01