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

Recruiting

• Conditions: COVID-19; Diabete Mellitus
• Interventions: Other: Measure of physiologic parameters

• Registration Number: NCT05867017
• Lead Sponsor: The University of Texas Health Science Center at San Antonio

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.

Study Timeline

• Study First Submitted: 2023-05-17
• Study First Submitted QC: 2023-05-17
• Study First Posted: 2023-05-19
• Study Start: 2023-07-10
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-19
• Last Update Posted: 2024-08-20
• Primary Completion: 2025-06
• Study Completion: 2026-08

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 213

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Severe COVID-19 Group	Measure of physiologic parameters	Hospitalized in ICU with COVID-19 (PCR positive) and recovered
COVID-19 negative Group	Measure of physiologic parameters	COVID-19 negative (by PCR) and seen in outpatient clinics or ER during same time period as Groups I and II.
Mild COVID-19 positive Group	Measure of physiologic parameters	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.

Primary Outcome Measures

Name	Time	Method
Measure of free plasma glucose (FPG)	Baseline to 24 months	Change in FPG
Measure of glycosylated glucose percentage (HbA1c)	Baseline to 24 months	Change in HbA1c, and indication of glucose levels over a 3 month period

Secondary Outcome Measures

Name	Time	Method
Body Weight	Baseline to 25 months	Change in body weight over the study period

Trial Locations

Locations (1)

Texas Diabetes Institute - University Health System; 🇺🇸 San Antonio, Texas, United States