- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT02916355
Role of Interleukin (IL)-1 in Postprandial Fatigue - The Chäschüechli 2 Study (Chäs2)
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.
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.
Přehled studie
Typ studie
Zápis (Aktuální)
Fáze
- Nelze použít
Kontakty a umístění
Studijní místa
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Basel, Švýcarsko, CH-4031 Basel
- University Hospital Basel, Department of Endocrinology, Diabetes and Metabolism
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Popis
Inclusion Criteria:
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.
Exclusion Criteria:
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)
- 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
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Jiný
- Přidělení: Randomizované
- Intervenční model: Crossover Assignment
- Maskování: Dvojnásobek
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
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Experimentální: Normal BMI
Healthy young men, normal BMI (BMI >18 and ≤28 kg/m2) will receive interventions Anakinra and sodium Chloride (NaCl)
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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.
Ostatní jména:
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.
Ostatní jména:
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Experimentální: Overweight
Healthy young men (BMI >30 and ≤35 kg/m2) will receive interventions Anakinra and NaCl
|
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.
Ostatní jména:
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.
Ostatní jména:
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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The primary outcome is change in fatigue measured by the SSS (Stanford Sleepiness Scale) between groups treated with Anakinra vs. placebo
Časové okno: 7 to 9 days (change between study day 1 and study day 2)
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Fatigue will be measured by using the SSS (Stanford Sleepiness Scale)
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7 to 9 days (change between study day 1 and study day 2)
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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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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).
Časové okno: 7 to 9 days (change between study day 1 and study day 2)
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Blood sampling
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7 to 9 days (change between study day 1 and study day 2)
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Change in heart rate due to any treatment (Anakinra vs. saline)
Časové okno: 7 to 9 days (change between study day 1 and study day 2)
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Pulse watch
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7 to 9 days (change between study day 1 and study day 2)
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Change in insulin due to any treatment (Anakinra vs. saline).
Časové okno: 7 to 9 days (change between study day 1 and study day 2)
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Blood sampling
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7 to 9 days (change between study day 1 and study day 2)
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Change in C-peptide due to any treatment (Anakinra vs. saline).
Časové okno: 7 to 9 days (change between study day 1 and study day 2)
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Blood sampling
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7 to 9 days (change between study day 1 and study day 2)
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Change in GLP-1(active/total) due to any treatment (Anakinra vs. saline).
Časové okno: 7 to 9 days (change between study day 1 and study day 2)
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Blood sampling
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7 to 9 days (change between study day 1 and study day 2)
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Change in GIP(active/total) due to any treatment (Anakinra vs. saline).
Časové okno: 7 to 9 days (change between study day 1 and study day 2)
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Blood sampling
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7 to 9 days (change between study day 1 and study day 2)
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Change in PYY due to any treatment (Anakinra vs. saline).
Časové okno: 7 to 9 days (change between study day 1 and study day 2)
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Blood sampling
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7 to 9 days (change between study day 1 and study day 2)
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Change in IL-6 due to any treatment (Anakinra vs. saline).
Časové okno: 7 to 9 days (change between study day 1 and study day 2)
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Blood sampling
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7 to 9 days (change between study day 1 and study day 2)
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Change in TNF-alfa due to any treatment (Anakinra vs. saline).
Časové okno: 7 to 9 days (change between study day 1 and study day 2)
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Blood sampling
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7 to 9 days (change between study day 1 and study day 2)
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Change in sCRP due to any treatment (Anakinra vs. saline).
Časové okno: 7 to 9 days (change between study day 1 and study day 2)
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Blood sampling
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7 to 9 days (change between study day 1 and study day 2)
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Change in cortisol due to any treatment (Anakinra vs. saline).
Časové okno: 7 to 9 days (change between study day 1 and study day 2)
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Blood sampling
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7 to 9 days (change between study day 1 and study day 2)
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Spolupracovníci a vyšetřovatelé
Spolupracovníci
Vyšetřovatelé
- Vrchní vyšetřovatel: Marc Y Donath, MD, University Hospital, Basel, Switzerland
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia
Primární dokončení (Aktuální)
Dokončení studie (Aktuální)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Odhad)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Další relevantní podmínky MeSH
Další identifikační čísla studie
- EKNZ BASEC 2016-00816
Plán pro data jednotlivých účastníků (IPD)
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