Status:
WITHDRAWN
High-Intensity Interval Training and Regulatory T Cells
Lead Sponsor:
Francesc Marti
Conditions:
End Stage Renal Disease
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief Summary
Regulatory T cells (Tregs) are a small population of T cells compromising of 1% to 5% of the total T cells in the body but they are playing a fundamental role in the maintenance of the immune homeosta...
Detailed Description
Tregs have been studied in clinical practice for different therapeutic applications. In the past several years there has been a significant interest in the transplant community to develop tolerance in...
Eligibility Criteria
Inclusion
- Age between 18 and 65 years old.
- BMI between 18.5 and 25 or above 30. Rationale: we want to include "obesity" as categorical covariate in the influence of HIIT and discriminate the participants between "lean" (BMI range 18.5-25) and "obese" (BMI \> 30)
- Sedentary lifestyle (fewer than 5,000 steps per day)
- Fluent in English, able to understand and provide informed consent.
- Subjects willing to participate in the study and comply with study requirements as evidenced by signed Institutional Review Board (IRB)-approved informed consent.
Exclusion
- Age under 18 or over 65
- BMI under 18.5 or between 25 and 30.
- Active lifestyle (more than 5,000 steps per day).
- Previous chronic use of systemic glucocorticoids, immune-suppressors or immuno-modulators in the preceding 3 months.
- Patients with significant or active infection: HIV negative by ELISA or reverse transcription polymerase chain reaction (RT-PCR) \[if ELISA is positive and RT-PCR is negative, the ELISA is considered false positive\]; negative serology for Hepatitis B and C.
- Active malignancy or history of malignancy within 1 year.
- Be pregnant or breastfeeding.
- Hemoglobin less than 9.0 g/dl at the time of blood drawing.
- Platelet count less than 100,000/\* at the time of blood drawing.
- White blood count less than 4 and/or Absolute Neutrophil Count less than 1500/\* at the time of blood drawing.
- Participation in any other study that involved investigational drug or regimens in the preceding 12 months.
- History of delayed or abnormal wound healing.
- Any immuno-related condition, chronic illness or prior treatment which, in the opinion of the investigator, precludes study participation.
- Inability or unwillingness of participant to comply with study protocol or procedures.
- Impaired consent capacity.
- Any chronic use of anticoagulation.
- Recipient of blood transfusion in 3 months prior to blood drawing.
- Any orthopedic condition or chronic pain that prevents them from cycling.
- Any symptomatic coronary artery disease prior enrollment within 3 months or any intervention for it in the past 6 months.
- Any symptomatic current heart failure (New York Heart Association class III and IV), significant valvar heart disease.
- History of non-compliance.
- The study will not include any vulnerable population such as fetuses, pregnant women, children, or prisoners.
Key Trial Info
Start Date :
January 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 30 2026
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04774484
Start Date
January 1 2023
End Date
June 30 2026
Last Update
February 14 2023
Active Locations (1)
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1
University of Kentucky Transplant Center
Lexington, Kentucky, United States, 40536