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Role of Interleukin (IL)-1 in Postprandial Fatigue - The Chäschüechli 2 Study (Chäs2)

25. januar 2018 opdateret af: University Hospital, Basel, Switzerland

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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

16

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Schweiz
      • Basel, Schweiz, CH-4031 Basel
        • University Hospital Basel, Department of Endocrinology, Diabetes and Metabolism

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

20 år til 65 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ja

Køn, der er berettiget til at studere

Han

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Andet
  • Tildeling: Randomiseret
  • Interventionel model: Crossover opgave
  • Maskning: Dobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Normal BMI
Healthy young men, normal BMI (BMI >18 and ≤28 kg/m2) will receive interventions Anakinra and sodium Chloride (NaCl)
Medicin: Anakinra
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.
Andre navne:
  • Kineret
Medicin: NaCl
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.
Andre navne:
  • natriumchlorid
Eksperimentel: Overweight
Healthy young men (BMI >30 and ≤35 kg/m2) will receive interventions Anakinra and NaCl
Medicin: Anakinra
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.
Andre navne:
  • Kineret
Medicin: NaCl
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.
Andre navne:
  • natriumchlorid

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
The primary outcome is change in fatigue measured by the SSS (Stanford Sleepiness Scale) between groups treated with Anakinra vs. placebo
Tidsramme: 7 to 9 days (change between study day 1 and study day 2)
Fatigue will be measured by using the SSS (Stanford Sleepiness Scale)
7 to 9 days (change between study day 1 and study day 2)

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
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).
Tidsramme: 7 to 9 days (change between study day 1 and study day 2)
Blood sampling
7 to 9 days (change between study day 1 and study day 2)
Change in heart rate due to any treatment (Anakinra vs. saline)
Tidsramme: 7 to 9 days (change between study day 1 and study day 2)
Pulse watch
7 to 9 days (change between study day 1 and study day 2)
Change in insulin due to any treatment (Anakinra vs. saline).
Tidsramme: 7 to 9 days (change between study day 1 and study day 2)
Blood sampling
7 to 9 days (change between study day 1 and study day 2)
Change in C-peptide due to any treatment (Anakinra vs. saline).
Tidsramme: 7 to 9 days (change between study day 1 and study day 2)
Blood sampling
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).
Tidsramme: 7 to 9 days (change between study day 1 and study day 2)
Blood sampling
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).
Tidsramme: 7 to 9 days (change between study day 1 and study day 2)
Blood sampling
7 to 9 days (change between study day 1 and study day 2)
Change in PYY due to any treatment (Anakinra vs. saline).
Tidsramme: 7 to 9 days (change between study day 1 and study day 2)
Blood sampling
7 to 9 days (change between study day 1 and study day 2)
Change in IL-6 due to any treatment (Anakinra vs. saline).
Tidsramme: 7 to 9 days (change between study day 1 and study day 2)
Blood sampling
7 to 9 days (change between study day 1 and study day 2)
Change in TNF-alfa due to any treatment (Anakinra vs. saline).
Tidsramme: 7 to 9 days (change between study day 1 and study day 2)
Blood sampling
7 to 9 days (change between study day 1 and study day 2)
Change in sCRP due to any treatment (Anakinra vs. saline).
Tidsramme: 7 to 9 days (change between study day 1 and study day 2)
Blood sampling
7 to 9 days (change between study day 1 and study day 2)
Change in cortisol due to any treatment (Anakinra vs. saline).
Tidsramme: 7 to 9 days (change between study day 1 and study day 2)
Blood sampling
7 to 9 days (change between study day 1 and study day 2)

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

University Hospital, Basel, Switzerland

Samarbejdspartnere

Rigshospitalet, Denmark

Efterforskere

  • Ledende efterforsker: Marc Y Donath, MD, University Hospital, Basel, Switzerland

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. august 2016

Primær færdiggørelse (Faktiske)

1. april 2017

Studieafslutning (Faktiske)

3. april 2017

Datoer for studieregistrering

Først indsendt

26. september 2016

Først indsendt, der opfyldte QC-kriterier

26. september 2016

Først opslået (Skøn)

27. september 2016

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

29. januar 2018

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

25. januar 2018

Sidst verificeret

1. januar 2018

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • EKNZ BASEC 2016-00816

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

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