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| ID | Type | Description | Link |
|---|---|---|---|
| OT2HL161847-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Severe COVID-19 Group | Hospitalized in ICU with COVID-19 (PCR positive) and recovered |
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| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Measure of physiologic parameters | Other | Participants will have hepatic muscle and adipose tissue insulin sensitivity tested |
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| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Body Weight | Change in body weight over the study period | Baseline to 24 months |
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Inclusion Criteria:
Exclusion Criteria:
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Three groups from background (general) population including Mexican ancestry will be studied, who have no history of diabetes or treatment with diabetes drugs prior to COVID-19 infection.
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| Name | Affiliation | Role |
|---|---|---|
| Ralph DeFronzo, MD | The University of Texas Health Science Center at San Antonio | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Texas Diabetes Institute - University Health System | San Antonio | Texas | 78207 | United States |
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| D003920 | Diabetes Mellitus |
| D007333 | Insulin Resistance |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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Plasma samples for future lipidomic and metabolomic analysis will be frozen at -80degC for later analysis.
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D006946 | Hyperinsulinism |