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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05867017
Other study ID # HSC20220656H
Secondary ID OT2HL161847-01
Status Recruiting
Phase
First received
Last updated
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
Health authority
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
Accepts healthy volunteers
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

Study Design


Related Conditions & MeSH terms


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
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