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

NCT04860869 | Completed Results

• 1 other identifier: 20-0361
• Study Type: observational
• Target: 23
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Covid19

Keywords

cognitive impairment; fatigue

Outcome Measures

Primary Outcomes (30)

• Insulin-Like Growth Factor-1 (IGF1)

  Insulin-Like Growth Factor-1 (IGF1) will be measured in serum. Results will be reported in ng/mL.

  baseline

• Follicle Stimulating Hormone (FSH)

  Follicle Stimulation Hormone (FSH) will be measured in serum.

  baseline

• Sex Hormone Binding Globulin (SHBG)

  Sex Hormone Binding Globulin (SHBG) will be measured in serum. Results will be reported in nmol/L.

  baseline

• Total Testosterone

  Total testosterone will be measured in serum of male subjects. Results will be reported in ng/dL.

  baseline

• Free Testosterone

  Free testosterone will be measured in serum of male subjects. Results will be reported in pg/mL.

  baseline

• Prolactin

  Prolactin will be measured in serum. Results will be reported in ng/mL.

  baseline

• Thyroid Stimulating Hormone (TSH)

  Thyroid Stimulating Hormone (TSH) will be measured in serum. Results will be reported in mUI/L.

  baseline

• C Reactive Protein (CRP)

  C Reactive Protein (CRP) will be measured in serum.

  baseline

• Vitamin B12

  Vitamin B12 will be measured in serum.

  baseline

• Vitamin D 25OH

  Vitamin D 25OH will be measured in serum.

  baseline

• Glucose Tolerance as Measured by the Oral Glucose Tolerance Test (OGTT) Before Glucose Consumption

  Glucose will be measured in serum before (0 minutes) oral consumption of 75g glucose. OGTT will be performed on PASC subjects only.

  Before glucose consumption

• Glucose Tolerance as Measured by the Oral Glucose Tolerance Test (OGTT) 120 Minutes After Glucose Consumption

  Glucose will be measured in serum at 120 minutes after oral consumption of 75g glucose. OGTT will be performed on PASC subjects only.

  120 minutes after glucose consumption

• Insulin as Measured by the Oral Glucose Tolerance Test (OGTT) Before Glucose Consumption

  Insulin will be measured in serum before (0 min) oral consumption of 75g glucose. OGTT will be performed on PASC subjects only.

  Before glucose consumption

• Insulin as Measured by the Oral Glucose Tolerance Test (OGTT) 120 Minutes After Glucose Consumption

  Insulin will be measured in serum at 120 minutes after oral consumption of 75g glucose. OGTT will be performed on PASC subjects only.

  120 minutes after glucose consumption

• Glucose Derived CO2 as Measured by Breath During the Oral Glucose Tolerance Test (OGTT) 120 Minutes After Glucose Consumption

  Glucose derived CO2 will be measured in breath samples at 120 minutes after oral consumption of 75g glucose isotopically labeled with 150 mg \[U-13C6\] glucose. Glucose-derived breath CO2 data are analyzed by measuring the ratios of 13CO2 to 12CO2 in single breath samples using an UBiT-IR300 infrared spectrophotometer (Otsuka Electronics, Hirakata, Osaka, Japan). The UBIT-IR300 calculates the difference in 13CO2 abundance from the baseline breath sample to each timed sample and expresses this as per mille delta over baseline (%DOB). OGTT will be performed on PASC subjects only.

  120 minutes after glucose consumption

• Sleep Quality as Measured by Pittsburgh Sleep Quality Index

  Pittsburgh Sleep Quality Index (PSQI) is a self-rated questionnaire which assesses sleep quality and disturbances over a 1 month-time interval. Minimum Score = 0 (better); Maximum Score = 21 (worse). Interpretation: Total \< 5 associated with good sleep quality. Total \> 5 associated with poor sleep quality.

  baseline

• Growth Hormone as Measured by Glucagon Stimulation Test Before Glucagon Administration

  Growth hormone secretion will be measured using the glucagon stimulation test. Serum will be collected for the baseline (time: 0 minutes) to test for levels of human growth hormone. 1 mg glucagon (for subjects over 90 kg, 1.5 mg glucagon) will be injected intramuscularly (IM) in the deltoid muscle of the subject and blood will be drawn at specified time points. Results will be reported as ng/mL.

  Before glucagon administration

• Growth Hormone as Measured by Glucagon Stimulation Test 90 Minutes After Glucagon Administration

  Growth hormone secretion will be measured using the glucagon stimulation test. Serum will be collected at time point 90 minutes after glucagon injection to test for levels of human growth hormone. Results will be reported as ng/mL.

  90 minutes after glucagon administration

• Growth Hormone as Measured by Glucagon Stimulation Test 120 Minutes After Glucagon Administration

  Growth hormone secretion will be measured using the glucagon stimulation test. Serum will be collected at timepoint 120 minutes after glucagon injection to test for levels of growth hormone. Results will be reported as ng/mL.

  120 minutes after glucagon administration

• Growth Hormone as Measured by Glucagon Stimulation Test 150 Minutes After Glucagon Administration

  Growth hormone secretion will be measured using the glucagon stimulation test. Serum will be collected at timepoint 150 minutes after glucagon injection to test for levels of growth hormone. Results will be reported as ng/mL.

  150 minutes after glucagon administration

• Growth Hormone as Measured by Glucagon Stimulation Test 180 Minutes After Glucagon Administration

  Growth hormone secretion will be measured using the glucagon stimulation test. Serum will be collected at timepoint 180 minutes after glucagon injection to test for levels of growth hormone. Results will be reported as ng/mL.

  180 minutes after glucagon administration

• Basal Metabolic Rate as Measured by Resting Energy Expenditure

  Resting Energy Expenditure will be measured by capturing the expired breath of subjects while at rest with a metabolic cart over a 30 minute time period. Data from the first 5 minutes will be discarded and the remaining 25 minutes of data will be averaged to calculate the resting energy expenditure. Data will be reported as kilocalories/day Procedure will be performed on PASC subjects only.

  baseline

• Cortisol as Measured by the Adrenocorticotropic Hormone Stimulation Test (ACTH) Before Cortrosyn Administration

  Cortisol secretion will be measured using the ACTH stimulation test. Serum will be collected for the baseline (time: 0 minutes) to test for levels of cortisol. 0.25 mg Cortrosyn will be administered and additional serum (3.5 mL) will be collected at specified time points. Results will be reported as ug/dL. Procedure will be performed on PASC subjects only.

  Before Cortrosyn administration

• Cortisol as Measured by the Adrenocorticotropic Hormone Stimulation Test (ACTH) 30 Minutes After Cortrosyn Administration

  Cortisol secretion will be measured using the ACTH stimulation test. Serum will be collected at time point 30 minutes after Cortrosyn administration to test for levels of cortisol. Procedure will be performed on PASC subjects only. Results will be reported as ug/dL.

  30 minutes after Cortrosyn administration

• Cortisol as Measured by the Adrenocorticotropic Hormone Stimulation Test (ACTH) 60 Minutes After Cortrosyn Administration

  Cortisol secretion will be measured using the ACTH stimulation test. Serum will be collected at time point 60 minutes after Cortrosyn administration to test for levels of cortisol. Results will be reported as ug/dL. Procedure will be performed on PASC subjects only.

  60 minutes after Cortrosyn administration

• Cognitive Function as Measured by Montreal Cognitive Assessment

  The Montreal Cognitive Assessment (MoCA) will be used to assess cognition. The Montreal Cognitive Assessment (MoCA) is a rapid assessment of cognition. The MoCA consists of 9 questions with the following subcategories: visuospatial/executive, naming, memory, language, abstraction, delayed recall and orientation. The MoCA has been used extensively to detect cognitive impairment in many conditions, including head trauma. Version 7.1 will be used. Scores range from 0 to 30, higher score being a better outcome.

  baseline

• Gastrointestinal Health Measured by the Gastrointestinal Symptom Rating Scale

  The Gastrointestinal Symptom Rating Scale (GSRS) is a specific 15-item questionnaire. Subjects are asked to numerically score their subjective symptoms on a scale of 1-7 (1 = no discomfort at all; 7 = very severe discomfort). The average of the scores for all 15 items is regarded as the GSRS total score. A higher score indicates a worse outcome.

  baseline

• Fatigue as Measured by the Multidimensional Fatigue Symptom Inventory

  Multidimensional Fatigue Symptom Inventory Short Form (MFSI-SF) from the Moffitt Cancer Center, University of South Florida The MFSI-SF is a 30 question assessment designed to assess the principal manifestations of fatigue. There 5 subscales used to calculate a total score. The subscales are: General Fatigue, Physical Fatigue, Emotional Fatigue, Mental Fatigue, and Vigor (an estimate of the patient's energy level). The total score is calculated with the equation: (general + physical + emotional + mental) - vigor = total score. The range of the total score is -24 to 96, with the higher the number meaning more fatigue.

  baseline

• Symptoms of Growth Hormone Deficiency Measured by the Questionnaire Quality of Life - Assessment of Growth Hormone Deficiency in Adults

  Symptoms of growth hormone deficiency will be measured using the Quality of Life - Assessment of Growth Hormone Deficiency in Adults (QoL-AGHDA). This 25-item questionnaire measures specific symptoms associated with growth hormone deficiency, with a score range of 0 to 25, with a higher score indicating worse symptoms.

  baseline

• Depression Measured by the Beck Depression Inventory-II

  The Beck Depression Inventory- II (BDI-II) assesses depressive symptom severity. The BDI-II is comprised of 21 individual items reflecting specific cognitive, affective, and physical symptoms of depression. Each item includes four statements that vary in the description of symptom of severity. Scores range from 0 to 3, with a score of "3" indicating a severe symptoms and a score of "0" indicating an absence of concern with that particular aspect of depressive symptomology. The total score is the sum of all endorsed statements. The maximum total score is 63. The BDI-II Manual designates the following raw score classifications depression severity: ≤13 = minimal; 14-19 = mild; 20-28 = moderate; ≥ 29 = severe.

  baseline

Secondary Outcomes (1)

• Free T4

  baseline

Study Arms (2)

symptomatic post-acute sequelae SARS-CoV-2 (PASC)

Patients with post-acute sequelae SARS-CoV-2 (PASC) after COVID-19 infection

non-symptomatic post-COVID

Patients with that recovered without lingering symptoms after being infected with COVID

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

1. Subjects recovered from COVID without lingering symptoms (nPASC) 2. Subjects with post-COVID syndrome (PASC)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• COVID Symptomatic Subjects (PASC)
• 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.

Sponsors & Collaborators

• The University of Texas Medical Branch, Galveston: lead

Study Sites (1)

The University of Texas Medical Branch

Galveston, Texas, 77555, United States

Location

Related Publications (1)

• Wright TJ, Pyles RB, Sheffield-Moore M, Deer RR, Randolph KM, McGovern KA, Danesi CP, Gilkison CR, Ward WW, Vargas JA, Armstrong PA, Lindsay SE, Zaidan MF, Seashore J, Wexler TL, Masel BE, Urban RJ. Low growth hormone secretion associated with post-acute sequelae SARS-CoV-2 infection (PASC) neurologic symptoms: A case-control pilot study. Mol Cell Endocrinol. 2024 Jan 1;579:112071. doi: 10.1016/j.mce.2023.112071. Epub 2023 Oct 8.

  PMID: 37816478 BACKGROUND

MeSH Terms

Conditions

COVID-19; Cognitive Dysfunction; Fatigue

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Randall Urban
• Organization: University of Texas Medical Branch

rurban@utmb.edu

409-772-5476

Study Officials

• Randall Urban, MD

  University of Texas

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 3, 2021
• First Posted: April 27, 2021
• Study Start: May 12, 2021
• Primary Completion: May 31, 2022
• Study Completion: May 31, 2022
• Last Updated: October 28, 2024
• Results First Posted: October 28, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)