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

COVID-19 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05867017
• Other study ID #: HSC20220656H
• Secondary ID: OT2HL161847-01
• Status: Recruiting
• Start date: July 10, 2023
• Est. completion date: August 2026

Study information

• Verified date: July 2023
• Source: The University of Texas Health Science Center at San Antonio
• Contact: Marzieh Salehi, MD
• Phone: (210) 567-6691
• Email: salehi[@]uthscsa.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 213
• Est. completion date: August 2026
• Est. primary completion date: June 2025
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• COVID-19
• Diabete Mellitus
• Diabetes Mellitus

Intervention

Other:
• Measure of physiologic parameters
Participants will have hepatic muscle and adipose tissue insulin sensitivity tested

Locations

Country	Name	City	State
United States	Texas Diabetes Institute - University Health System	San Antonio	Texas

Sponsors (2)

Lead Sponsor	Collaborator
The University of Texas Health Science Center at San Antonio	National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Measure of glycosylated glucose percentage (HbA1c)	Change in HbA1c, and indication of glucose levels over a 3 month period	Baseline to 24 months
Primary	Measure of free plasma glucose (FPG)	Change in FPG	Baseline to 24 months
Secondary	Body Weight	Change in body weight over the study period	Baseline to 25 months