Clinical trial NCT05867017: Long-Term Sequelae of SARS-COV-2 Infection: Diabetes Mellitus
Official title: Long-Term Sequelae of SARS-COV-2 Infection: Diabetes Mellitus
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: COVID-19
Diabete Mellitus
Keywords: Glycemic control
Long term medical effects of COVID-19
Blood glucose control
Insulin sensitivity
Lead sponsor: The University of Texas Health Science Center at San Antonio
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2023-05-19
Enrollment: 213
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Observational model: OTHER
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

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.

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

Primary outcomes:
measure: Measure of glycosylated glucose percentage (HbA1c)
timeFrame: Baseline to 24 months
measure: Measure of free plasma glucose (FPG)
timeFrame: Baseline to 24 months
Secondary outcomes:
measure: Body Weight
timeFrame: Baseline to 25 months
Other outcomes:
Locations:
city: San Antonio
country: United States
facility: Texas Diabetes Institute - University Health System
state: Texas
Study officials:
affiliation: University of Texas Health Science Center San Antonio
name: Ralph DeFronzo, MD
role: PRINCIPAL_INVESTIGATOR
References: