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OpenTrials
Completed

NCT Number: NCT05867017

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

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.

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Key information

Conditions

COVID-19 Coronaviridae Infections Coronavirus Infections Diabete Mellitus Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Hyperinsulinism Infections Insulin Resistance Lung Diseases Metabolic Diseases Nidovirales Infections Nutritional and Metabolic Diseases Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Texas Diabetes Institute - University Health System

San Antonio, Texas, 78207, United States

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Measure of physiologic parameters

Other

Participants will have hepatic muscle and adipose tissue insulin sensitivity tested

Primary outcomes

  1. Measure of glycosylated glucose percentage (HbA1c)

    Time frame: Baseline to 24 months

    Change in HbA1c, and indication of glucose levels over a 3 month period

  2. Measure of free plasma glucose (FPG)

    Time frame: Baseline to 24 months

    Change in FPG

Secondary outcomes

  1. Body Weight

    Time frame: Baseline to 24 months

    Change in body weight over the study period

Sponsors and collaborators

Lead sponsor

The University of Texas Health Science Center at San Antonio

Other

Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)

Registry information

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
May 19, 2023
Registry last updated
Jan 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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