COVID-19NCT05867017
Long-Term Sequelae of SARS-COV-2 Infection: Diabetes Mellitus
An observational study of COVID-19 and Diabete Mellitus, run by The University of Texas Health Science Center at San Antonio at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- COVID-19, Diabete Mellitus
- What is being tested?
- Measure of physiologic parameters
- How many people
- 23 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Jul 2023to 30 Nov 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Adult, Older adult
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.
Who may be able to join
- Body Mass index (BMI) < 40 kg/m2
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Texas Diabetes Institute - University Health System
San Antonio, Texas, 78207
About this study
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.
Read the 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.
- Conditions
- COVID-19, Diabete Mellitus
- Being tested
- Measure of physiologic parameters
- Keywords
- Glycemic control, Long term medical effects of COVID-19, Blood glucose control, Insulin sensitivity
- Medical subject headings
- COVID-19, Diabetes Mellitus, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Measure of physiologic parametersOther
Participants will have hepatic muscle and adipose tissue insulin sensitivity tested
| Study group | Role | What they receive |
|---|---|---|
| Severe COVID-19 Group | Hospitalized in ICU with COVID-19 (PCR positive) and recovered Receives: Other: Measure of physiologic parameters | |
| 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. Receives: Other: Measure of physiologic parameters | |
| 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. Receives: Other: Measure of physiologic parameters |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measure of glycosylated glucose percentage (HbA1c)
Change in HbA1c, and indication of glucose levels over a 3 month period
Measured: Baseline to 24 months
Measure of free plasma glucose (FPG)
Change in FPG
Measured: Baseline to 24 months
Secondary outcomes (1)
Body Weight
Change in body weight over the study period
Measured: Baseline to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2023
- Study start10 Jul 2023
- Primary completion30 Nov 2025
- Study completion30 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies of the same condition, open and under way.
- More trials run by The University of Texas Health Science Center at San AntonioThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Sponsor
- Investigators
- Ralph DeFronzo, MD, Principal investigator, The University of Texas Health Science Center at San Antonio
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05867017
- Sponsor's protocol ID
- HSC20220656H
- Other IDs
- OT2HL161847-01
- Status last verified
- Jan 2026
- First submitted
- 17 May 2023
- Last updated
- 7 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-Term Sequelae of SARS-COV-2 Infection: Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT05867017
- Acronym / sponsor ID
- HSC20220656H
- Conditions
- COVID-19, Diabete Mellitus
- Keywords
- Glycemic control, Long term medical effects of COVID-19, Blood glucose control, Insulin sensitivity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- The University of Texas Health Science Center at San AntonioUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 10 Jul 2023 (actual)
- Primary completion
- 30 Nov 2025 (actual)
- Study completion
- 30 Nov 2025 (actual)
- First posted
- 19 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Other
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Severe COVID-19 Group | – | Other: Measure of physiologic parametersHospitalized in ICU with COVID-19 (PCR positive) and recovered |
| Mild COVID-19 positive Group | – | Other: Measure of physiologic parametersCOVID-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. |
| COVID-19 negative Group | – | Other: Measure of physiologic parametersCOVID-19 negative (by PCR) and seen in outpatient clinics or ER during same time period as Groups I and II. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- Body Mass index (BMI) < 40 kg/m2
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Measure of physiologic parametersParticipants will have hepatic muscle and adipose tissue insulin sensitivity tested | Other | COVID-19 negative Group, Mild COVID-19 positive Group, Severe COVID-19 Group |
Primary outcome
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
Measure of free plasma glucose (FPG)
Time frame: Baseline to 24 months
Change in FPG
1 secondary outcome
Body Weight
Time frame: Baseline to 24 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jan 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ralph DeFronzo, MD principal investigator
The University of Texas Health Science Center at San Antonio
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COVID-19 and Diabete Mellitus, run by The University of Texas Health Science Center at San Antonio at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measure of glycosylated glucose percentage (HbA1c) (time frame: Baseline to 24 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jan 2026.