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

University Hospital Basel

Status: Completed

Conditions: Adiposity

Treatments: Drug: NaCl; Drug: Anakinra

Study type: Interventional

Funder types: Other

Identifiers

NCT02916355

EKNZ BASEC 2016-00816

Details and patient eligibility

About

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.

Enrollment: 16 patients

Sex: Male

Ages: 20 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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16 participants in 2 patient groups

Normal BMI

Experimental group

Description:

Healthy young men, normal BMI (BMI \>18 and ≤28 kg/m2) will receive interventions Anakinra and sodium Chloride (NaCl)

Treatment:

Drug: Anakinra

Drug: NaCl

Overweight

Experimental group

Description:

Healthy young men (BMI \>30 and ≤35 kg/m2) will receive interventions Anakinra and NaCl

Treatment:

Drug: Anakinra

Drug: NaCl