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

NCT ID: NCT05867017

Last Updated: 2026-01-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

23 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-07-10

Study Completion Date

2025-11-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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COVID-19 Diabete Mellitus

Study Design

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Observational Model Type

OTHER

Study Time Perspective

OTHER

Study Groups

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Severe COVID-19 Group

Hospitalized in ICU with COVID-19 (PCR positive) and recovered

Measure of physiologic parameters

Intervention Type OTHER

Participants will have hepatic muscle and adipose tissue insulin sensitivity tested

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.

Measure of physiologic parameters

Intervention Type OTHER

Participants will have hepatic muscle and adipose tissue insulin sensitivity tested

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.

Measure of physiologic parameters

Intervention Type OTHER

Participants will have hepatic muscle and adipose tissue insulin sensitivity tested

Interventions

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Measure of physiologic parameters

Participants will have hepatic muscle and adipose tissue insulin sensitivity tested

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role collaborator

The University of Texas Health Science Center at San Antonio

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ralph DeFronzo, MD

Role: PRINCIPAL_INVESTIGATOR

University of Texas Health Science Center San Antonio

Locations

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Texas Diabetes Institute - University Health System

San Antonio, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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OT2HL161847-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

HSC20220656H

Identifier Type: -

Identifier Source: org_study_id

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