N/A N=23

Endocrine, Metabolic and Microbiome Influence on the Post-acute Sequelae SARS-CoV-2 (PASC)

Covid19

Bottom Line

View on ClinicalTrials.gov: NCT04860869 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Oct 2024

Primary outcome: Primary: Insulin-Like Growth Factor-1 (IGF1) — 142.8; 137.6 ng/ml

Study Design & Population

Study type: Observational
Phase: N/A
Interventions: —
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: The University of Texas Medical Branch, Galveston
Primary completion: May 2022

Outcome Measures

Outcome	Result	p-value
PRIMARY Insulin-Like Growth Factor-1 (IGF1)	142.8; 137.6	—
PRIMARY Follicle Stimulating Hormone (FSH)	38.2; 24.1	—
PRIMARY Sex Hormone Binding Globulin (SHBG)	46.4; 97.7	—
PRIMARY Total Testosterone	508.0; 292.5	—
PRIMARY Free Testosterone	27.9; 76.0	—
PRIMARY Prolactin	11.5; 9.5	—
PRIMARY Thyroid Stimulating Hormone (TSH)	2.38; 1.60	—
PRIMARY C Reactive Protein (CRP)	0.47; 0.38	—
PRIMARY Vitamin B12	553.7; 446.1	—
PRIMARY Vitamin D 25OH	30.6; 41.1	—
PRIMARY Glucose Tolerance as Measured by the Oral Glucose Tolerance Test (OGTT) Before Glucose Consumption	91.9	—
PRIMARY Glucose Tolerance as Measured by the Oral Glucose Tolerance Test (OGTT) 120 Minutes After Glucose Consumption	150.3	—
PRIMARY Insulin as Measured by the Oral Glucose Tolerance Test (OGTT) Before Glucose Consumption	7.4	—
PRIMARY Insulin as Measured by the Oral Glucose Tolerance Test (OGTT) 120 Minutes After Glucose Consumption	82.0	—
PRIMARY Glucose Derived CO2 as Measured by Breath During the Oral Glucose Tolerance Test (OGTT) 120 Minutes After Glucose Consumption	40.9	—
PRIMARY Sleep Quality as Measured by Pittsburgh Sleep Quality Index	11.1; 4.5	—
PRIMARY Growth Hormone as Measured by Glucagon Stimulation Test Before Glucagon Administration	0.4; 0.9	—
PRIMARY Growth Hormone as Measured by Glucagon Stimulation Test 90 Minutes After Glucagon Administration	0.6; 1.6	—
PRIMARY Growth Hormone as Measured by Glucagon Stimulation Test 120 Minutes After Glucagon Administration	2.2; 5.6	—
PRIMARY Growth Hormone as Measured by Glucagon Stimulation Test 150 Minutes After Glucagon Administration	2.6; 5.8	—
PRIMARY Growth Hormone as Measured by Glucagon Stimulation Test 180 Minutes After Glucagon Administration	2.3; 3.0	—
PRIMARY Basal Metabolic Rate as Measured by Resting Energy Expenditure	1489.2	—
PRIMARY Cortisol as Measured by the Adrenocorticotropic Hormone Stimulation Test (ACTH) Before Cortrosyn Administration	5.3	—
PRIMARY Cortisol as Measured by the Adrenocorticotropic Hormone Stimulation Test (ACTH) 30 Minutes After Cortrosyn Administration	17.9	—
PRIMARY Cortisol as Measured by the Adrenocorticotropic Hormone Stimulation Test (ACTH) 60 Minutes After Cortrosyn Administration	21.7	—
PRIMARY Cognitive Function as Measured by Montreal Cognitive Assessment	27.0; 27.9	—
PRIMARY Gastrointestinal Health Measured by the Gastrointestinal Symptom Rating Scale	2.5; 1.4	—
PRIMARY Fatigue as Measured by the Multidimensional Fatigue Symptom Inventory	31.0; -14.0	—
PRIMARY Symptoms of Growth Hormone Deficiency Measured by the Questionnaire Quality of Life - Assessment of Growth Hormone Deficiency in Adults	13.6; 2.4	—
PRIMARY Depression Measured by the Beck Depression Inventory-II	16.8; 2.2	—
SECONDARY Free T4	1.05; 1.19	—

Summary

The aim of this study is characterize the endocrine, metabolic and microbiomes of patients with post-acute sequelae SARS-CoV-2 infection (PASC) and patients that have recovered from COVID without lingering symptoms.

Eligibility Criteria

COVID Non-Symptomatic controls (nPASC)

Inclusion criteria

Male or female with a history of COVID with diagnosis confirmed by PCR test.
Minimum of 6 months since diagnosis of COVID by PCR test.
Ages 18 to 80 years.
Participant is willing and able to give informed consent for participation in the study.

Exclusion criteria

Current COVID infection.
Unable to walk unassisted.
Significant heart, liver, kidney, blood or respiratory disease as determined by Principal Investigator.
Uncontrolled diabetes mellitus.
Any history of a recently (12 months) diagnosed cancer other than a skin cancer (excluding melanoma).
Current alcohol or drug abuse.
History of psychosis.
Pregnancy or become pregnant during the trial.
Subjects who are being managed with narcotics will be excluded as the effects of central nervous system depressants may interfere with study test results.
Other medical condition or medication administration deemed exclusionary by the study investigators.

COVID Symptomatic Subjects (PASC)

Inclusion Criteria

Male or female with a history of COVID with diagnosis confirmed by PCR test.
Has been seen at UTMB Post COVID clinic.
Minimum of 6 months since diagnosis of COVID by PCR test.
Ages 18 to 80 years.
Score of 3 or higher on any question 1-3 of the Brief Fatigue Inventory (BFI) questionnaire.
Participant is willing and able to give informed consent for participation in the study.

Exclusion Criteria

Current COVID infection.
Unable to walk unassisted.
Significant heart, liver, kidney, blood or respiratory disease.
Uncontrolled diabetes mellitus.
Any history of a recently (12 months) diagnosed cancer other than a skin cancer (excluding melanoma).
Current alcohol or drug abuse.
History of psychosis.
Pregnancy or become pregnant during the trial.
Subjects who are being managed with narcotics will be excluded as the effects of central nervous system depressants may interfere with study test results.
Other medical condition or medication administration deemed exclusionary by the study investigators.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04860869). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.