Clinical trial NCT04273022: Effect of Exercise on Biomarkers in SCT
Official title: The Effect of Exercise on Resting Biomarkers in Subjects With Sickle Cell Trait
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sickle Cell Trait
Keywords: Sickle Cell Trait
Lead sponsor: St. Louis University
Sponsor class: OTHER
Collaborators: name: American Society for Clinical Laboratory Science
First posted: 2020-02-17
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: SCT subjects will be evaluated for activation of five physiological pathways by measuring 15 biomarkers before and after a single bout of moderate exercise. The control group will confirm normal biomarkers at rest and determine the natural response to moderate exercise.
Primary purpose: DIAGNOSTIC

Brief summary: This study measures the effect of exercise on a variety of biomarkers in blood and urine selected to evaluate the physiological pathways of hemolysis, myolysis, thrombosis, inflammation, and renal function in subjects with sickle cell trait. These pathways have been shown to be associated with adverse events in athletes and warfighters with SCT upon protracted, repeated, strenuous exertion. Changes in biomarkers post-exercise compared to pre-exercise (and compared to healthy controls) suggest activation of the associated pathway(s) which may contribute to exercise-related events in athletes and warfighters and subclinical complications in non-athletes.

Detailed description: Subjects with sickle cell trait and healthy controls will be subjected to a single bout of moderate, controlled exercise on a treadmill. Blood and urine samples will be collected before exercise, immediately after exercise, and 24 hours after exercise. Fifteen biomarkers, three selected to evaluate each of the five physiologic pathways previously listed, will be tested at each of the three time points. Abnormal biomarkers before exercise suggest chronic pathway activation while exacerbated levels after exercise suggest further activation stimulated by exercise. Biomarker levels 24 hours post-exercise will be used to evaluate continued pathway activation or pathway recovery. By definition, 95% of health controls will show normal biomarker levels pre-exercise and biomarker patterns post-exercise will serve as the expected standard by which to compare the test subjects.

Eligibility criteria: Inclusion Criteria: Sickle Cell Trait Group (AS)

* Health subjects with sickle cell trait (AS)
* Ages 18-70 years

Inclusion Criteria: Control group (AA)

* Healthy subjects without sickle cell trait (AA)
* Ages 18-70 years

Exclusion Criteria: Sickle Cell Trait group (AS) AND healthy controls (AA).

Subjects will be excluded if they:

* weigh less than 110 pounds,
* are pregnant,
* have hemoglobinopathies (other than sickle cell trait) as determined by Hb electrophoresis,
* have other self-reported conditions known to cause blood coagulation activation, myocyte destruction, hemolysis, chronic inflammation, or renal disease
* any condition that places subjects at risk during exercise.

Primary outcomes:
measure: Change in reticulocyte count
timeFrame: Immediately before, immediately after, & 24 hours after a single bout of submaximal exercise on a treadmill
measure: Change in erythrocyte morphology amounts
timeFrame: Immediately before, immediately after, & 24 hours after a single bout of submaximal exercise on a treadmill
measure: Change in haptoglobin level
timeFrame: Immediately before, immediately after, & 24 hours after a single bout of submaximal exercise on a treadmill
measure: Change in potassium (K+) level
timeFrame: Immediately before, immediately after, & 24 hours after a single bout of submaximal exercise on a treadmill
measure: Change in creatine kinase (CK) level
timeFrame: Immediately before, immediately after, & 24 hours after a single bout of submaximal exercise on a treadmill
measure: Change in serum myoglobin level
timeFrame: Immediately before, immediately after, & 24 hours after a single bout of submaximal exercise on a treadmill
measure: Change in urine myoglobin level
timeFrame: Immediately before, immediately after, & 24 hours after a single bout of submaximal exercise on a treadmill
measure: Change in D-dimer level
timeFrame: Immediately before, immediately after, & 24 hours after a single bout of submaximal exercise on a treadmill
measure: Change in fibrin monomer level
timeFrame: Immediately before, immediately after, & 24 hours after a single bout of submaximal exercise on a treadmill
measure: Change in antithrombin III (ATIII) level
timeFrame: Immediately before, immediately after, & 24 hours after a single bout of submaximal exercise on a treadmill
measure: Change in C-reactive protein (CRP) level
timeFrame: Immediately before, immediately after, & 24 hours after a single bout of submaximal exercise on a treadmill
measure: Change in erythrocyte sedimentation rate (ESR) level
timeFrame: Immediately before, immediately after, & 24 hours after a single bout of submaximal exercise on a treadmill
measure: Change in 11-dehydrothrombaxaneB2 (11-DTXB2) level
timeFrame: Immediately before, immediately after, & 24 hours after a single bout of submaximal exercise on a treadmill
measure: Change in complete urinalysis results
timeFrame: Immediately before, immediately after, & 24 hours after a single bout of submaximal exercise on a treadmill
measure: Change in microalbumin level
timeFrame: Immediately before, immediately after, & 24 hours after a single bout of submaximal exercise on a treadmill
Secondary outcomes:
Other outcomes:
Locations:
city: Saint Louis
country: United States
facility: Saint Louis University
state: Missouri
Study officials:
affiliation: St. Louis University
name: Tim R Randolph, PhD
role: PRINCIPAL_INVESTIGATOR
References: