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

Adiposity Clinical Trial

— Chäs2  

Official title:

Role of IL-1 in Postprandial Fatigue - The Chäschüechli 2 Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02916355
• Other study ID #: EKNZ BASEC 2016-00816
• Status: Completed
• Phase: N/A
• First received: September 26, 2016
• Last updated: January 25, 2018
• Start date: August 2016
• Est. completion date: April 3, 2017

Study information

• Verified date: January 2018
• Source: University Hospital, Basel, Switzerland
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: April 3, 2017
• Est. primary completion date: April 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 20 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Adiposity
• Fatigue

Intervention

Drug:
• 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.
• 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.

Locations

Country	Name	City	State
Switzerland	University Hospital Basel, Department of Endocrinology, Diabetes and Metabolism	Basel

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Basel, Switzerland	Rigshospitalet, Denmark

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	7 to 9 days (change between study day 1 and study day 2)
Secondary	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	7 to 9 days (change between study day 1 and study day 2)
Secondary	Change in heart rate due to any treatment (Anakinra vs. saline)	Pulse watch	7 to 9 days (change between study day 1 and study day 2)
Secondary	Change in insulin due to any treatment (Anakinra vs. saline).	Blood sampling	7 to 9 days (change between study day 1 and study day 2)
Secondary	Change in C-peptide due to any treatment (Anakinra vs. saline).	Blood sampling	7 to 9 days (change between study day 1 and study day 2)
Secondary	Change in GLP-1(active/total) due to any treatment (Anakinra vs. saline).	Blood sampling	7 to 9 days (change between study day 1 and study day 2)
Secondary	Change in GIP(active/total) due to any treatment (Anakinra vs. saline).	Blood sampling	7 to 9 days (change between study day 1 and study day 2)
Secondary	Change in PYY due to any treatment (Anakinra vs. saline).	Blood sampling	7 to 9 days (change between study day 1 and study day 2)
Secondary	Change in IL-6 due to any treatment (Anakinra vs. saline).	Blood sampling	7 to 9 days (change between study day 1 and study day 2)
Secondary	Change in TNF-alfa due to any treatment (Anakinra vs. saline).	Blood sampling	7 to 9 days (change between study day 1 and study day 2)
Secondary	Change in sCRP due to any treatment (Anakinra vs. saline).	Blood sampling	7 to 9 days (change between study day 1 and study day 2)
Secondary	Change in cortisol due to any treatment (Anakinra vs. saline).	Blood sampling	7 to 9 days (change between study day 1 and study day 2)