- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06484101
Functional Characterization of CD8+ T Cells After Supramaximal Exercise
June 28, 2024 updated by: Helene Rundqvist, Karolinska Institutet
Effekten av högintensiv träning på Vita Blodkroppar, Med Speciellt Fokus på Funktion Kopplad Till Att bekämpa Cancerceller
Healthy human subjects perform supramaximal exercise with venous blood samples obtained before and up to 60 minutes after the exercise bout.
Study Overview
Status
Completed
Intervention / Treatment
Detailed Description
Healthy, human subjects perform 3 x 30 seconds of supramaximal exercise.
Venous blood samples were obtained before and up to 60 minutes after the exercise bout.
The blood was used for absolute count of lymphocytes and monocytes per volume blood, and for isolation of CD8+ T cells.
It was also used for blood gas analysis.
The CD8+ T cells were characterized using flow cytometry, and then cultured for 7 days with CD8+ activation beads.
The cells were counted and analyzed for viability at day4 and day8.
RNAseq was performed on CD8+ cells isolated before and directly after exercise.
CD8+ T cells from Day 1 pre and post exercise and then after 7 days of culture, were analyzed for IFNgamma release using Elispot, and for cytotoxicity against HEK cancer cells in vitro.
Flow cytometry of CD8+ T cells was performed on fresh CD8 T cells pre and post exercise, and then on day4 and day8 after culture.
SeaHorse metabolic assay was done on Day1 CD8 T cells obtained pre and post exercise.
Study Type
Interventional
Enrollment (Actual)
7
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Stockholm
-
Huddinge, Stockholm, Sweden
- Karolinska Sjukhuset Huddinge
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- Be used to physical exercise and be able to perform strenous exercise Be able to attend the experimental procedure for the 90 minute duration of the study
Exclusion Criteria:
- Smoking Pregnant Have any medical condition requiring medical treatment
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Exercise
Healthy human subjects performing 3 x 30 seconds of supramaximal exercise with blood obtained before and up to 60 minutes after the exercise bout
|
3 x 30 seconds of supramaximal exercise
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
CD8 T cell absolute nr after exercise
Time Frame: Before, directly after, 60 minutes after exercise
|
CD8 nr
|
Before, directly after, 60 minutes after exercise
|
|
CD8 T cell cytotoxicity against cancer cells
Time Frame: Cryopreserved CD8 cells from Day 1 and Day 8 of the experiment, obtained before and after exercise
|
CD8 T cell lysis of cancer cells
|
Cryopreserved CD8 cells from Day 1 and Day 8 of the experiment, obtained before and after exercise
|
|
CD8 T cell pheontype after exercise
Time Frame: Before, directly after, 30 minutes and 60 minutes after exercise
|
Flow cytometry analysis of CD8 T cells
|
Before, directly after, 30 minutes and 60 minutes after exercise
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Helene Rundqvist, PhD, Karolinska Institutet
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 31, 2023
Primary Completion (Actual)
December 22, 2023
Study Completion (Actual)
February 14, 2024
Study Registration Dates
First Submitted
June 18, 2024
First Submitted That Met QC Criteria
June 28, 2024
First Posted (Actual)
July 3, 2024
Study Record Updates
Last Update Posted (Actual)
July 3, 2024
Last Update Submitted That Met QC Criteria
June 28, 2024
Last Verified
June 1, 2024
More Information
Terms related to this study
Other Study ID Numbers
- 2023-01066-01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.