AdiposityChäs2NCT02916355
Role of Interleukin (IL)-1 in Postprandial Fatigue - The Chäschüechli 2 Study
A study testing Anakinra and NaCl in people with Adiposity, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
Trial summary
Role of IL-1 in postprandial fatigue - The Chäschüechli 2 Study It is a randomized, single dose, placebo-controlled, double blind, cross-over, proof-of-concept study. 16 healthy young men will be included in this study. The objective of this study is to evaluate if severity of postprandial fatigue is driven by IL-1. Read more about this study
- Who is it for?
- Ages 20 to 65 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Adiposity
- What is being tested?
- Anakinra and NaCl
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteSwitzerland
- Study dates
- Aug 2016to 3 Apr 2017
- 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 20 to 65 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male subjects
- non-smoking
- apparently healthy
- BMI >18 and ≤28 kg/m2 or BMI >30 and ≤35 kg/m2
- Age 20-65 years
- Subject is usually eating breakfast and lunch
- Willingness to use contraceptive measures adequate to prevent the subject's partner from becoming pregnant during the study. Adequate contraceptive measures include hormonal methods used for two or more cycles prior to screening (e.g., oral contraceptive pills, contraceptive patch, or contraceptive vaginal ring), double barrier methods (e.g., contraceptive sponge, diaphragm used in conjunction with contraceptive foam or jelly, and condom used in conjunction with contraceptive foam or jelly), intrauterine methods (IUD) and sterilization (e.g., tubal ligation or a monogamous relationship with a vasectomized partner).
- Owner of a smartphone so they will be able to download and use the sleeping APP, Sleep cycle, prior to the study days.
Who cannot join
- Subjects will be excluded from the study if they meet any of the following criteria:
- Night shift workers
- Subjects suffering from sleep disturbances
- Clinical signs of infection in the week before inclusion or history of infection during the last 2 months (CRP >5mg/l)
- Impaired fasting glucose (fasting plasma glucose >5.5mmol/l)
- Hematologic disease (leukocyte count < 1.5x109/l, hemoglobin <11 g/dl, platelets <100 x 103/ul)
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- Kidney disease (creatinine > 1.5 mg/dl))
- Liver disease (transaminases >2x upper normal range)
- Heart disease
- Pulmonary disease
- Inflammatory disease
- History of carcinoma
- History of tuberculosis
- Alcohol consumption >40g/d
- Smoking
- Known allergy towards Kineret
- Known allergy to ingredients of the test meal
- Current treatment with any drug in the week before inclusion, including vitamin supplementation (especially vitamin C and E)
- Use of any investigational drug within 30 days prior to enrolment or within 5 half-lives of the investigational drug, whichever is longer
- Subject refusing or unable to give written informed consent
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
University Hospital Basel, Department of Endocrinology, Diabetes and Metabolism
Basel, CH-4031 Basel
About this study
Official title: Role of IL-1 in Postprandial Fatigue - The Chäschüechli 2 Study
Role of IL-1 in postprandial fatigue - The Chäschüechli 2 Study It is a randomized, single dose, placebo-controlled, double blind, cross-over, proof-of-concept study.
16 healthy young men will be included in this study. The objective of this study is to evaluate if severity of postprandial fatigue is driven by IL-1.
Read more
Since fatigue is associated with increased cytokine levels, and since fatigue in chronic inflammatory settings, such as type 2 diabetes, can be reduced by inhibition of IL-1β, postprandial fatigue might also respond to anti-inflammatory intervention with IL-1 inhibition.
The aim of the study is to investigate whether postprandial fatigue is, at least in part, driven by the IL-1 system.
- Conditions
- Adiposity
- Being tested
- Anakinra, NaCl
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AnakinraDrug
Also called Kineret
Subjects will receive Anakinra infusion and afterwards they will be fed a very fat containing meal, and postprandial fatigue will be measured regularly until 3,5 hour after the meal.
NaClDrug
Also called sodium chloride
subjects will receive NaCl infusion and afterwards they will be fed a very fat containing meal, and postprandial fatigue will be measured regularly until 3,5 hour after the meal.
| Study group | Role | What they receive |
|---|---|---|
| Normal BMI | Experimental | Healthy young men, normal BMI (BMI >18 and ≤28 kg/m2) will receive interventions Anakinra and sodium Chloride (NaCl) Receives: Drug: Anakinra; Drug: NaCl |
| Overweight | Experimental | Healthy young men (BMI >30 and ≤35 kg/m2) will receive interventions Anakinra and NaCl Receives: Drug: Anakinra; Drug: NaCl |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary outcome is change in fatigue measured by the SSS (Stanford Sleepiness Scale) between groups treated with Anakinra vs. placebo
Fatigue will be measured by using the SSS (Stanford Sleepiness Scale)
Measured: 7 to 9 days (change between study day 1 and study day 2)
Secondary outcomes (11)
Change in postprandial glucose, insulin, C-peptide, glucagon-like Peptide (GLP)-1(active/total), GIP(active/total), PYY, IL-6, tumor necrosis factor (TNF)-alfa, sCRP and cortisol due to any treatment (Anakinra vs. saline).
Blood sampling
Measured: 7 to 9 days (change between study day 1 and study day 2)
Change in heart rate due to any treatment (Anakinra vs. saline)
Pulse watch
Measured: 7 to 9 days (change between study day 1 and study day 2)
Change in insulin due to any treatment (Anakinra vs. saline).
Blood sampling
Measured: 7 to 9 days (change between study day 1 and study day 2)
Change in C-peptide due to any treatment (Anakinra vs. saline).
Blood sampling
Measured: 7 to 9 days (change between study day 1 and study day 2)
Change in GLP-1(active/total) due to any treatment (Anakinra vs. saline).
Blood sampling
Measured: 7 to 9 days (change between study day 1 and study day 2)
Change in GIP(active/total) due to any treatment (Anakinra vs. saline).
Blood sampling
Measured: 7 to 9 days (change between study day 1 and study day 2)
Change in PYY due to any treatment (Anakinra vs. saline).
Blood sampling
Measured: 7 to 9 days (change between study day 1 and study day 2)
Change in IL-6 due to any treatment (Anakinra vs. saline).
Blood sampling
Measured: 7 to 9 days (change between study day 1 and study day 2)
Change in TNF-alfa due to any treatment (Anakinra vs. saline).
Blood sampling
Measured: 7 to 9 days (change between study day 1 and study day 2)
Change in sCRP due to any treatment (Anakinra vs. saline).
Blood sampling
Measured: 7 to 9 days (change between study day 1 and study day 2)
Change in cortisol due to any treatment (Anakinra vs. saline).
Blood sampling
Measured: 7 to 9 days (change between study day 1 and study day 2)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2016 (estimated)
- Study startAug 2016
- Primary completionApr 2017
- Study completion3 Apr 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AdiposityStudies of the same condition, open and under way.
- More trials run by University Hospital, Basel, SwitzerlandThe sponsor's other registered studies.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Collaborators
- Copenhagen University Hospital, Rigshospitalet
- Responsible party
- Sponsor
- Investigators
- Marc Y Donath, MD, Principal investigator, University Hospital, Basel, Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02916355
- Sponsor's protocol ID
- EKNZ BASEC 2016-00816
- Acronym
- Chäs2
- Status last verified
- Jan 2018
- First submitted
- 26 Sep 2016
- Last updated
- 29 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of IL-1 in Postprandial Fatigue - The Chäschüechli 2 Study
- ClinicalTrials.gov ID
- NCT02916355
- Acronym / sponsor ID
- Chäs2 / EKNZ BASEC 2016-00816
- Conditions
- Adiposity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Collaborators
- Copenhagen University Hospital, Rigshospitalet
- Study start
- Aug 2016
- Primary completion
- Apr 2017 (actual)
- Study completion
- 3 Apr 2017 (actual)
- First posted
- 27 Sep 2016 (estimated)
- 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.
Role of IL-1 in postprandial fatigue - The Chäschüechli 2 Study It is a randomized, single dose, placebo-controlled, double blind, cross-over, proof-of-concept study.
16 healthy young men will be included in this study. The objective of this study is to evaluate if severity of postprandial fatigue is driven by IL-1.
Since fatigue is associated with increased cytokine levels, and since fatigue in chronic inflammatory settings, such as type 2 diabetes, can be reduced by inhibition of IL-1β, postprandial fatigue might also respond to anti-inflammatory intervention with IL-1 inhibition.
The aim of the study is to investigate whether postprandial fatigue is, at least in part, driven by the IL-1 system.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Normal BMI | Experimental | Drug: Anakinra, Drug: NaClHealthy young men, normal BMI (BMI >18 and ≤28 kg/m2) will receive interventions Anakinra and sodium Chloride (NaCl) |
| Overweight | Experimental | Drug: Anakinra, Drug: NaClHealthy young men (BMI >30 and ≤35 kg/m2) will receive interventions Anakinra and NaCl |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Male subjects
- non-smoking
- apparently healthy
- BMI >18 and ≤28 kg/m2 or BMI >30 and ≤35 kg/m2
- Age 20-65 years
Key exclusion criteria (20 listed)
- Night shift workers
- Subjects suffering from sleep disturbances
- Clinical signs of infection in the week before inclusion or history of infection during the last 2 months (CRP >5mg/l)
- Impaired fasting glucose (fasting plasma glucose >5.5mmol/l)
- Hematologic disease (leukocyte count < 1.5x109/l, hemoglobin <11 g/dl, platelets <100 x 103/ul)
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 |
|---|---|---|
| AnakinraAlso: KineretSubjects will receive Anakinra infusion and afterwards they will be fed a very fat containing meal, and postprandial fatigue will be measured regularly until 3,5 hour after the meal. | Drug | Normal BMI, Overweight |
| NaClAlso: sodium chloridesubjects will receive NaCl infusion and afterwards they will be fed a very fat containing meal, and postprandial fatigue will be measured regularly until 3,5 hour after the meal. | Drug | Normal BMI, Overweight |
Primary outcome
The primary outcome is change in fatigue measured by the SSS (Stanford Sleepiness Scale) between groups treated with Anakinra vs. placebo
Time frame: 7 to 9 days (change between study day 1 and study day 2)
Fatigue will be measured by using the SSS (Stanford Sleepiness Scale)
11 secondary outcomes
Change in postprandial glucose, insulin, C-peptide, glucagon-like Peptide (GLP)-1(active/total), GIP(active/total), PYY, IL-6, tumor necrosis factor (TNF)-alfa, sCRP and cortisol due to any treatment (Anakinra vs. saline).
Time frame: 7 to 9 days (change between study day 1 and study day 2)
Change in heart rate due to any treatment (Anakinra vs. saline)
Time frame: 7 to 9 days (change between study day 1 and study day 2)
Change in insulin due to any treatment (Anakinra vs. saline).
Time frame: 7 to 9 days (change between study day 1 and study day 2)
Change in C-peptide due to any treatment (Anakinra vs. saline).
Time frame: 7 to 9 days (change between study day 1 and study day 2)
Change in GLP-1(active/total) due to any treatment (Anakinra vs. saline).
Time frame: 7 to 9 days (change between study day 1 and study day 2)
Change in GIP(active/total) due to any treatment (Anakinra vs. saline).
Time frame: 7 to 9 days (change between study day 1 and study day 2)
Change in PYY due to any treatment (Anakinra vs. saline).
Time frame: 7 to 9 days (change between study day 1 and study day 2)
Change in IL-6 due to any treatment (Anakinra vs. saline).
Time frame: 7 to 9 days (change between study day 1 and study day 2)
Change in TNF-alfa due to any treatment (Anakinra vs. saline).
Time frame: 7 to 9 days (change between study day 1 and study day 2)
Change in sCRP due to any treatment (Anakinra vs. saline).
Time frame: 7 to 9 days (change between study day 1 and study day 2)
Change in cortisol due to any treatment (Anakinra vs. saline).
Time frame: 7 to 9 days (change between study day 1 and study day 2)
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 29 Jan 2018.
- 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.
Marc Y Donath, MD principal investigator
University Hospital, Basel, Switzerland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Anakinra and NaCl in people with Adiposity, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
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 8 inclusion and 20 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 29 Jan 2018. 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 Switzerland. 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. 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?
The primary outcome is change in fatigue measured by the SSS (Stanford Sleepiness Scale) between groups treated with Anakinra vs. placebo (time frame: 7 to 9 days (change between study day 1 and study day 2)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Jan 2018.