Glycogen DepletionREX-6NCT05349149
IL-6 Regulation of Energy Stores During Recovery From an Acute Exercise Bout
A study testing Tocilizumab/Actemra® (Roche) and Saline 9% in people with Glycogen Depletion, run by Helga Ellingsgaard at 1 site in Denmark.
Trial summary
The aim of the study is to investigate the role of exercise-induced IL-6 in regulating energy stores and energy metabolism during recovery after an acute exercise bout. To achieve this, 30 men will be randomized to infusion placebo or tocilizumab (IL-6 receptor antibody) combined with a 2-hour exercise bout. Read more about this study
- Who is it for?
- Ages 18 to 40 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Glycogen Depletion
- What is being tested?
- Tocilizumab/Actemra® (Roche) and Saline 9%
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteDenmark
- Study dates
- 20 Apr 2022to 11 Oct 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Physically active (defined as meeting the ACSM's guidelines of 2.5h per week of moderate to vigorous physical activity per week), young, healthy males will be included. Participants may be included in the study if they meet all the following criteria:
- Age ≥ 18 years and ≤ 40 years
- BMI < 18 and > 25 kg/m2
- Healthy (based on screening)
- Stable body weight for 6 months
- ≥ 2.5h/week moderate to vigorous physical activity
Who cannot join
- • Cardiovascular disease
- Rheumatologic disease
- Metabolic disease
- Elite sports or high aerobic training status (VO2max > 60 mL O2/min/kg)
- Frequent/chronic use of medications affecting physical performance or inflammation (NSAIDS, DMARDS, corticosteroids)
- Aspirin use >100 mg/d
Show all 16Show fewer
- Thyroid disease
- Current infection
- Aspartate amino transferase (AST) or alanine amino transferase (ALT) >2x upper normal range
- History of carcinoma
- History of tuberculosis
- Ketogenic diet
- Smoking
- Anemia (hematocrit <33%)
- Neutrophil count <0,5x 109/l
- Thrombocytes <50x 109/l or bleeding disorders
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Centre for Physical Activity Research, Rigshospitalet Section 7641
Copenhagen, Capital Region, 2100
About this study
Official title: Role of IL-6 in Regulating Energy Stores During Recovery From an Acute Exercise Bout
The aim of the study is to investigate the role of exercise-induced IL-6 in regulating energy stores and energy metabolism during recovery after an acute exercise bout. To achieve this, 30 men will be randomized to infusion placebo or tocilizumab (IL-6 receptor antibody) combined with a 2-hour exercise bout. Stable isotope tracers will be infused to determine substrate kinetics. Indirect calorimetry will be applied to determine substrate oxidation, and muscle biopsies will be taken to determine substrate uptake and storage.
- Conditions
- Glycogen Depletion
- Being tested
- Tocilizumab/Actemra® (Roche), Saline 9%
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tocilizumab/Actemra® (Roche)Drug
The infusion of tocilizumab will antagonize IL-6 signaling for the duration of the study, allowing us to determine the role of IL-6 in regulating energy stores following acute exercise
Saline 9%Drug
The infusion of saline will serve as placebo for tocilizumab, allowing us to determine the role of IL-6 in regulating energy stores following acute exercise
| Study group | Role | What they receive |
|---|---|---|
| Tocilizumab | Experimental | Participants will receive one 30 min intravenous infusion of tocilizumab/Actemra® (Roche). The dose will be 8 mg/kg bodyweight or a maximum of 800mg. Tocilizumab is dissolved in 100 mL 0.9% saline. Receives: Drug: Tocilizumab/Actemra® (Roche) |
| Saline | Placebo comparator | As placebo, participants will receive one 30 min intravenous infusion of 100 mL 0.9% saline. Receives: Drug: Saline 9% |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in muscle glycogen content (mmol/kg/h)
Comparing change in muscle glycogen in the two groups from before exercise to immediately after exercise, and after 1 hour and 4 hours of recovery
Measured: Measured at 0, 120, 180 and 360 minutes
Change in muscle triglycerides content
Comparing change in muscle triglycerides in the two groups from before exercise to immediately after exercise, and after 1 hour and 4 hours of recovery
Measured: Measured at 0, 120, 180 and 360 minutes
Change in muscle expression of glucose transporter type 4 (GLUT4)
Comparing muscle expression of GLUT4 before and immediately after exercise and 4 hours after recovery in the two groups
Measured: Measured at 0, 120 and 360 min
Change in muscle expression of fatty acid translocase (FAT/CD36)
Comparing muscle expression of FAT/CD36 before and immediately after exercise and 4 hours after recovery in the two groups
Measured: Measured at 0, 120 and 360 min
Change in muscle expression of muscle fatty acid binding protein (FABPm)
Comparing muscle expression of FABPm before and immediately after exercise and 4 hours after recovery in the two groups
Measured: Measured at 0, 120 and 360 min
Change in muscle expression of fatty acid transporter 4 (FATP4)
Comparing muscle expression of FATP4 before and immediately after exercise and 4 hours after recovery in the two groups
Measured: Measured at 0, 120 and 360 min
Change in muscle expression of glycerol transporters
Comparing muscle expression of glycerol transporters before and immediately after exercise and 4 hours after recovery in the two groups
Measured: Measured at 0, 120 and 360 min
Secondary outcomes (40)
Change in glucose rate of appearance
Comparing glucose rate of appearance during exercise and recovery in the two groups
Measured: Measured at -150, -60, -45, -30, 10, 30, 60, 90, 120, 130, 150, 180, 210, 240, 300 and 360 minutes
Change in glucose rate of disappearance
Comparing glucose rate of disappearance during exercise and recovery in the two groups
Measured: Measured at -150, -60, -45, -30, 10, 30, 60, 90, 120, 130, 150, 180, 210, 240, 300 and 360 minutes
Change in glucose concentration
Comparing glucose concentration during exercise and recovery in the two groups
Measured: Measured at -150, -60, -45, -30, 10, 30, 60, 90, 120, 130, 150, 180, 210, 240, 300 and 360 minutes
Change in glucose enrichment in intramuscular glycogen
Comparing glucose enrichment in intramuscular glycogen during rest, exercise and recovery in the two groups
Measured: Measured at 0, 120, 180 and 360 minutes
Change in intramuscular glucose concentration
Comparing intramuscular glucose concentration during rest, exercise and recovery in the two groups
Measured: Measured at 0, 120, 180 and 360 minutes
Change in glycogen fractional synthesis rate
Comparing intramuscular glycogen fractional synthesis rate during rest, exercise and recovery in the two groups
Measured: Measured at 0, 120, 180 and 360 minutes
Change in gylcerol rate of appearance
Comparing gylcerol rate of appearance during rest, exercise and recovery in the two groups
Measured: Measured at -150, -60, -45, -30, 10, 30, 60, 90, 120, 130, 150, 180, 210, 240, 300 and 360 minutes
Change in gylcerol rate of disappearance
Comparing gylcerol rate of disappearance during rest, exercise and recovery in the two groups
Measured: Measured at -150, -60, -45, -30, 10, 30, 60, 90, 120, 130, 150, 180, 210, 240, 300 and 360 minutes
Change in gylcerol concentration
Comparing gylcerol concentration during rest, exercise and recovery in the two groups
Measured: Measured at -150, -60, -45, -30, 10, 30, 60, 90, 120, 130, 150, 180, 210, 240, 300 and 360 minutes
Change in palmitate rate of appearance
Comparing palmitate rate of appearance during rest, exercise and recovery in the two groups
Measured: Measured at -150, -60, -45, -30, 10, 30, 60, 90, 120, 130, 150, 180, 210, 240, 300 and 360 minutes
Change in palmitate rate of disappearance
Comparing palmitate rate of disappearance during rest, exercise and recovery in the two groups
Measured: Measured at -150, -60, -45, -30, 10, 30, 60, 90, 120, 130, 150, 180, 210, 240, 300 and 360 minutes
Change in palmitate concentration
Comparing palmitate kinetics during rest, exercise and recovery in the two groups
Measured: Measured at -150, -60, -45, -30, 10, 30, 60, 90, 120, 130, 150, 180, 210, 240, 300 and 360 minutes
Change in palmitate oxidation
Comparing palmitate oxidation during rest, exercise and recovery in the two groups
Measured: Measured at -150, -60, -45, -30, 10, 30, 60, 90, 120, 130, 150, 180, 210, 240, 300 and 360 minutes
Change in intramuscular palmitate content
Comparing intramuscular palmitate content during rest, exercise and recovery in the two groups
Measured: Measured at 0, 120, 180 and 360 minutes
Change in palmitate enrichment in intramuscular triglycerides
Comparing palmitate enrichment in intramuscular triglycerides during rest, exercise and recovery in the two groups
Measured: Measured at 0, 120, 180 and 360 minutes
Change in intramuscular triglycerides fractional synthesis rate
Comparing intramuscular triglycerides fractional synthesis rate during rest, exercise and recovery in the two groups
Measured: Measured at 0, 120, 180 and 360 minutes
Change in haemoglobin
Comparing haemoglobin during rest, exercise and recovery in the two groups
Measured: Measured at -150, -30, 10, 30, 60, 90, 120, 130, 150, 180, 210, 240, 300 and 360 minutes
Change in haematocrit
Comparing haematocrit during rest, exercise and recovery in the two groups
Measured: Measured at -150, -30, 10, 30, 60, 90, 120, 130, 150, 180, 210, 240, 300 and 360 minutes
Change in differential blood count
Comparing differential blood count during rest, exercise and recovery in the two groups
Measured: Measured at -150, -30, 10, 30, 60, 90, 120, 130, 150, 180, 210, 240, 300 and 360 minutes
Change in plasma IL-6 concentration
Comparing plasma IL-6 concentration during rest, exercise and recovery in the two groups
Measured: Measured at -150, -30, 10, 30, 60, 90, 120, 130, 150, 180, 210, 240, 300 and 360 minutes
Change in plasma TNF-alpha concentration
Comparing plasma TNF-alpha concentration during rest, exercise and recovery in the two groups
Measured: Measured at -150, -30, 10, 30, 60, 90, 120, 130, 150, 180, 210, 240, 300 and 360 minutes
Change in plasma IL-8 concentration
Comparing plasma IL-8 concentration during rest, exercise and recovery in the two groups
Measured: Measured at -150, -30, 10, 30, 60, 90, 120, 130, 150, 180, 210, 240, 300 and 360 minutes
Change in plasma IL-10 concentration
Comparing plasma IL-10 concentration during rest, exercise and recovery in the two groups
Measured: Measured at -150, -30, 10, 30, 60, 90, 120, 130, 150, 180, 210, 240, 300 and 360 minutes
Change in plasma IL-1beta concentration
Comparing plasma IL-1beta concentration during rest, exercise and recovery in the two groups
Measured: Measured at -150, -30, 10, 30, 60, 90, 120, 130, 150, 180, 210, 240, 300 and 360 minutes
Change in plasma IL-1Ra concentration
Comparing plasma IL-1Ra concentration during rest, exercise and recovery in the two groups
Measured: Measured at -150, -30, 10, 30, 60, 90, 120, 130, 150, 180, 210, 240, 300 and 360 minutes
Change in plasma IL-4 concentration
Comparing plasma IL-4 concentration during rest, exercise and recovery in the two groups
Measured: Measured at -150, -30, 10, 30, 60, 90, 120, 130, 150, 180, 210, 240, 300 and 360 minutes
Change in plasma sIL-6R concentration
Comparing plasma sIL-6R concentration during rest, exercise and recovery in the two groups
Measured: Measured at -150, -30, 10, 30, 60, 90, 120, 130, 150, 180, 210, 240, 300 and 360 minutes
Change in insulin
Comparing insulin during rest, exercise and recovery in the two groups
Measured: Measured at -150, -30, 10, 30, 60, 90, 120, 130, 150, 180, 210, 240, 300 and 360 minutes
Change in c-peptide
Comparing c-peptide during rest, exercise and recovery in the two groups
Measured: Measured at -150, -30, 10, 30, 60, 90, 120, 130, 150, 180, 210, 240, 300 and 360 minutes
Change in glucagon
Comparing glucagon during rest, exercise and recovery in the two groups
Measured: Measured at -150, -30, 10, 30, 60, 90, 120, 130, 150, 180, 210, 240, 300 and 360 minutes
Change in growth hormone (GH)
Comparing GH during rest, exercise and recovery in the two groups
Measured: Measured at -150, -30, 10, 30, 60, 90, 120, 130, 150, 180, 210, 240, 300 and 360 minutes
Change in adrenaline
Comparing adrenaline during rest, exercise and recovery in the two groups
Measured: Measured at -150, -30, 10, 30, 60, 90, 120, 130, 150, 180, 210, 240, 300 and 360 minutes
Change in noradrenaline
Comparing noradrenaline during rest, exercise and recovery in the two groups
Measured: Measured at -150, -30, 10, 30, 60, 90, 120, 130, 150, 180, 210, 240, 300 and 360 minutes
Change in cortisol
Comparing cortisol during rest, exercise and recovery in the two groups
Measured: Measured at -150, -30, 10, 30, 60, 90, 120, 130, 150, 180, 210, 240, 300 and 360 minutes
Change in total glucagon-like peptide-1 (GLP-1)
Comparing total GLP-1 during rest, exercise and recovery in the two groups
Measured: Measured at -150, -30, 10, 30, 60, 90, 120, 130, 150, 180, 210, 240, 300 and 360 minutes
Change in active GLP-1
Comparing active GLP-1 during rest, exercise and recovery in the two groups
Measured: Measured at -150, -30, 10, 30, 60, 90, 120, 130, 150, 180, 210, 240, 300 and 360 minutes
Change in gastric inhibitory peptide (GIP)
Comparing GIP during rest, exercise and recovery in the two groups
Measured: Measured at -150, -30, 10, 30, 60, 90, 120, 130, 150, 180, 210, 240, 300 and 360 minutes
Change in peptide YY (PYY)
Comparing PYY during rest, exercise and recovery in the two groups
Measured: Measured at -150, -30, 10, 30, 60, 90, 120, 130, 150, 180, 210, 240, 300 and 360 minutes
Change in leptin
Comparing leptin during rest, exercise and recovery in the two groups
Measured: Measured at -150, -30, 10, 30, 60, 90, 120, 130, 150, 180, 210, 240, 300 and 360 minutes
Change in triglycerides
Comparing triglycerides during rest, exercise and recovery in the two groups
Measured: Measured at -150, -30, 10, 30, 60, 90, 120, 130, 150, 180, 210, 240, 300 and 360 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2022
- Study start20 Apr 2022
- Primary completion11 Oct 2022
- Study completion11 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Glycogen DepletionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized, placebo-controlled, double-blind
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Helga Ellingsgaard
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Helga Ellingsgaard, Copenhagen University Hospital, Rigshospitalet
- Investigators
- Bente K Pedersen, MD, Study chair, Copenhagen University Hospital, Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05349149
- Sponsor's protocol ID
- H-21063697
- Acronym
- REX-6
- Status last verified
- Oct 2022
- First submitted
- 6 Apr 2022
- Last updated
- 26 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kistner TM, Trinh B, Mfeketo K, van Hall G, Pedersen BK, Lieberman DE, Ellingsgaard H. Myokine IL-6 activity enhances post-exercise fatty acid accumulation in skeletal muscle but does not affect glycogen resynthesis. Mol Metab. 2026 Jan;103:102283. doi: 10.1016/j.molmet.2025.102283. Epub 2025 Nov 14.
PubMed 41242537
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of IL-6 in Regulating Energy Stores During Recovery From an Acute Exercise Bout
- ClinicalTrials.gov ID
- NCT05349149
- Acronym / sponsor ID
- REX-6 / H-21063697
- Conditions
- Glycogen Depletion
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Helga EllingsgaardUniversity, hospital or other
- Study start
- 20 Apr 2022 (actual)
- Primary completion
- 11 Oct 2022 (actual)
- Study completion
- 11 Oct 2022 (actual)
- First posted
- 27 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of the study is to investigate the role of exercise-induced IL-6 in regulating energy stores and energy metabolism during recovery after an acute exercise bout. To achieve this, 30 men will be randomized to infusion placebo or tocilizumab (IL-6 receptor antibody) combined with a 2-hour exercise bout. Stable isotope tracers will be infused to determine substrate kinetics. Indirect calorimetry will be applied to determine substrate oxidation, and muscle biopsies will be taken to determine substrate uptake and storage.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Randomized, placebo-controlled, double-blind
| Arm | Type | Receives |
|---|---|---|
| Tocilizumab | Experimental | Drug: Tocilizumab/Actemra® (Roche)Participants will receive one 30 min intravenous infusion of tocilizumab/Actemra® (Roche). The dose will be 8 mg/kg bodyweight or a maximum of 800mg. Tocilizumab is dissolved in 100 mL 0.9% saline. |
| Saline | Placebo comparator | Drug: Saline 9%As placebo, participants will receive one 30 min intravenous infusion of 100 mL 0.9% saline. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Physically active (defined as meeting the ACSM's guidelines of 2.5h per week of moderate to vigorous physical activity per week), young, healthy males will be included. Participants may be included in the study if they meet all the following criteria:
Key exclusion criteria (16 listed)
- • Cardiovascular disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tocilizumab/Actemra® (Roche)The infusion of tocilizumab will antagonize IL-6 signaling for the duration of the study, allowing us to determine the role of IL-6 in regulating energy stores following acute exercise | Drug | Tocilizumab |
| Saline 9%The infusion of saline will serve as placebo for tocilizumab, allowing us to determine the role of IL-6 in regulating energy stores following acute exercise | Drug | Saline |
Primary outcome
Change in muscle glycogen content (mmol/kg/h)
Time frame: Measured at 0, 120, 180 and 360 minutes
Comparing change in muscle glycogen in the two groups from before exercise to immediately after exercise, and after 1 hour and 4 hours of recovery
Change in muscle triglycerides content
Time frame: Measured at 0, 120, 180 and 360 minutes
Comparing change in muscle triglycerides in the two groups from before exercise to immediately after exercise, and after 1 hour and 4 hours of recovery
Change in muscle expression of glucose transporter type 4 (GLUT4)
Time frame: Measured at 0, 120 and 360 min
Comparing muscle expression of GLUT4 before and immediately after exercise and 4 hours after recovery in the two groups
Change in muscle expression of fatty acid translocase (FAT/CD36)
Time frame: Measured at 0, 120 and 360 min
Comparing muscle expression of FAT/CD36 before and immediately after exercise and 4 hours after recovery in the two groups
Change in muscle expression of muscle fatty acid binding protein (FABPm)
Time frame: Measured at 0, 120 and 360 min
Comparing muscle expression of FABPm before and immediately after exercise and 4 hours after recovery in the two groups
Change in muscle expression of fatty acid transporter 4 (FATP4)
Time frame: Measured at 0, 120 and 360 min
Comparing muscle expression of FATP4 before and immediately after exercise and 4 hours after recovery in the two groups
Change in muscle expression of glycerol transporters
Time frame: Measured at 0, 120 and 360 min
Comparing muscle expression of glycerol transporters before and immediately after exercise and 4 hours after recovery in the two groups
40 secondary outcomes
Change in glucose rate of appearance
Time frame: Measured at -150, -60, -45, -30, 10, 30, 60, 90, 120, 130, 150, 180, 210, 240, 300 and 360 minutes
Change in glucose rate of disappearance
Time frame: Measured at -150, -60, -45, -30, 10, 30, 60, 90, 120, 130, 150, 180, 210, 240, 300 and 360 minutes
Change in glucose concentration
Time frame: Measured at -150, -60, -45, -30, 10, 30, 60, 90, 120, 130, 150, 180, 210, 240, 300 and 360 minutes
Change in glucose enrichment in intramuscular glycogen
Time frame: Measured at 0, 120, 180 and 360 minutes
Change in intramuscular glucose concentration
Time frame: Measured at 0, 120, 180 and 360 minutes
Change in glycogen fractional synthesis rate
Time frame: Measured at 0, 120, 180 and 360 minutes
Change in gylcerol rate of appearance
Time frame: Measured at -150, -60, -45, -30, 10, 30, 60, 90, 120, 130, 150, 180, 210, 240, 300 and 360 minutes
Change in gylcerol rate of disappearance
Time frame: Measured at -150, -60, -45, -30, 10, 30, 60, 90, 120, 130, 150, 180, 210, 240, 300 and 360 minutes
Change in gylcerol concentration
Time frame: Measured at -150, -60, -45, -30, 10, 30, 60, 90, 120, 130, 150, 180, 210, 240, 300 and 360 minutes
Change in palmitate rate of appearance
Time frame: Measured at -150, -60, -45, -30, 10, 30, 60, 90, 120, 130, 150, 180, 210, 240, 300 and 360 minutes
Change in palmitate rate of disappearance
Time frame: Measured at -150, -60, -45, -30, 10, 30, 60, 90, 120, 130, 150, 180, 210, 240, 300 and 360 minutes
Change in palmitate concentration
Time frame: Measured at -150, -60, -45, -30, 10, 30, 60, 90, 120, 130, 150, 180, 210, 240, 300 and 360 minutes
Change in palmitate oxidation
Time frame: Measured at -150, -60, -45, -30, 10, 30, 60, 90, 120, 130, 150, 180, 210, 240, 300 and 360 minutes
Change in intramuscular palmitate content
Time frame: Measured at 0, 120, 180 and 360 minutes
Change in palmitate enrichment in intramuscular triglycerides
Time frame: Measured at 0, 120, 180 and 360 minutes
Change in intramuscular triglycerides fractional synthesis rate
Time frame: Measured at 0, 120, 180 and 360 minutes
Change in haemoglobin
Time frame: Measured at -150, -30, 10, 30, 60, 90, 120, 130, 150, 180, 210, 240, 300 and 360 minutes
Change in haematocrit
Time frame: Measured at -150, -30, 10, 30, 60, 90, 120, 130, 150, 180, 210, 240, 300 and 360 minutes
Change in differential blood count
Time frame: Measured at -150, -30, 10, 30, 60, 90, 120, 130, 150, 180, 210, 240, 300 and 360 minutes
Change in plasma IL-6 concentration
Time frame: Measured at -150, -30, 10, 30, 60, 90, 120, 130, 150, 180, 210, 240, 300 and 360 minutes
Change in plasma TNF-alpha concentration
Time frame: Measured at -150, -30, 10, 30, 60, 90, 120, 130, 150, 180, 210, 240, 300 and 360 minutes
Change in plasma IL-8 concentration
Time frame: Measured at -150, -30, 10, 30, 60, 90, 120, 130, 150, 180, 210, 240, 300 and 360 minutes
Change in plasma IL-10 concentration
Time frame: Measured at -150, -30, 10, 30, 60, 90, 120, 130, 150, 180, 210, 240, 300 and 360 minutes
Change in plasma IL-1beta concentration
Time frame: Measured at -150, -30, 10, 30, 60, 90, 120, 130, 150, 180, 210, 240, 300 and 360 minutes
Change in plasma IL-1Ra concentration
Time frame: Measured at -150, -30, 10, 30, 60, 90, 120, 130, 150, 180, 210, 240, 300 and 360 minutes
Change in plasma IL-4 concentration
Time frame: Measured at -150, -30, 10, 30, 60, 90, 120, 130, 150, 180, 210, 240, 300 and 360 minutes
Change in plasma sIL-6R concentration
Time frame: Measured at -150, -30, 10, 30, 60, 90, 120, 130, 150, 180, 210, 240, 300 and 360 minutes
Change in insulin
Time frame: Measured at -150, -30, 10, 30, 60, 90, 120, 130, 150, 180, 210, 240, 300 and 360 minutes
Change in c-peptide
Time frame: Measured at -150, -30, 10, 30, 60, 90, 120, 130, 150, 180, 210, 240, 300 and 360 minutes
Change in glucagon
Time frame: Measured at -150, -30, 10, 30, 60, 90, 120, 130, 150, 180, 210, 240, 300 and 360 minutes
Change in growth hormone (GH)
Time frame: Measured at -150, -30, 10, 30, 60, 90, 120, 130, 150, 180, 210, 240, 300 and 360 minutes
Change in adrenaline
Time frame: Measured at -150, -30, 10, 30, 60, 90, 120, 130, 150, 180, 210, 240, 300 and 360 minutes
Change in noradrenaline
Time frame: Measured at -150, -30, 10, 30, 60, 90, 120, 130, 150, 180, 210, 240, 300 and 360 minutes
Change in cortisol
Time frame: Measured at -150, -30, 10, 30, 60, 90, 120, 130, 150, 180, 210, 240, 300 and 360 minutes
Change in total glucagon-like peptide-1 (GLP-1)
Time frame: Measured at -150, -30, 10, 30, 60, 90, 120, 130, 150, 180, 210, 240, 300 and 360 minutes
Change in active GLP-1
Time frame: Measured at -150, -30, 10, 30, 60, 90, 120, 130, 150, 180, 210, 240, 300 and 360 minutes
Change in gastric inhibitory peptide (GIP)
Time frame: Measured at -150, -30, 10, 30, 60, 90, 120, 130, 150, 180, 210, 240, 300 and 360 minutes
Change in peptide YY (PYY)
Time frame: Measured at -150, -30, 10, 30, 60, 90, 120, 130, 150, 180, 210, 240, 300 and 360 minutes
Change in leptin
Time frame: Measured at -150, -30, 10, 30, 60, 90, 120, 130, 150, 180, 210, 240, 300 and 360 minutes
Change in triglycerides
Time frame: Measured at -150, -30, 10, 30, 60, 90, 120, 130, 150, 180, 210, 240, 300 and 360 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2022.
- Derived from this study: PubMed 41242537Kistner TM, Trinh B, Mfeketo K, van Hall G, Pedersen BK, Lieberman DE, Ellingsgaard H. Myokine IL-6 activity enhances post-exercise fatty acid accumulation in skeletal muscle but does not affect glycogen resynthesis. Mol Metab. 2026 Jan;103:102283. doi: 10.1016/j.molmet.2025.102283. Epub 2025 Nov 14.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bente K Pedersen, MD study chair
Copenhagen University Hospital, Rigshospitalet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tocilizumab/Actemra® (Roche) and Saline 9% in people with Glycogen Depletion, run by Helga Ellingsgaard at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in muscle glycogen content (mmol/kg/h) (time frame: Measured at 0, 120, 180 and 360 minutes). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05349149, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2022.