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

Primary Purpose

Adiposity

Status

Completed

Phase

Not Applicable

Locations

Switzerland

Study Type

Interventional

Intervention

Anakinra

NaCl

About this trial

This is an interventional other trial for Adiposity

Eligibility Criteria

20 Years - 65 Years (Adult, Older Adult)MaleAccepts 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

Sites / Locations

University Hospital Basel, Department of Endocrinology, Diabetes and Metabolism

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Normal BMI

Overweight

Arm Description

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

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

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

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

Change in heart rate due to any treatment (Anakinra vs. saline)

Pulse watch

Change in insulin due to any treatment (Anakinra vs. saline).

Blood sampling

Change in C-peptide due to any treatment (Anakinra vs. saline).

Blood sampling

Change in GLP-1(active/total) due to any treatment (Anakinra vs. saline).

Blood sampling

Change in GIP(active/total) due to any treatment (Anakinra vs. saline).

Blood sampling

Change in PYY due to any treatment (Anakinra vs. saline).

Blood sampling

Change in IL-6 due to any treatment (Anakinra vs. saline).

Blood sampling

Change in TNF-alfa due to any treatment (Anakinra vs. saline).

Blood sampling

Change in sCRP due to any treatment (Anakinra vs. saline).

Blood sampling

Change in cortisol due to any treatment (Anakinra vs. saline).

Blood sampling

Full Information

NCT ID

NCT02916355

First Posted

September 26, 2016

Last Updated

January 25, 2018

Sponsor

University Hospital, Basel, Switzerland

Collaborators

Rigshospitalet, Denmark

1. Study Identification

Unique Protocol Identification Number

NCT02916355

Brief Title

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

Acronym

Chäs2

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2018

Overall Recruitment Status

Completed

Study Start Date

August 2016 (undefined)

Primary Completion Date

April 2017 (Actual)

Study Completion Date

April 3, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University Hospital, Basel, Switzerland

Collaborators

Rigshospitalet, Denmark

4. Oversight

Data Monitoring Committee

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Adiposity

7. Study Design

Primary Purpose

Other

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

16 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Normal BMI

Arm Type

Experimental

Arm Description

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

Arm Title

Overweight

Arm Type

Experimental

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Anakinra

Other Intervention Name(s)

Kineret

Intervention Description

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.

Intervention Type

Drug

Intervention Name(s)

NaCl

Other Intervention Name(s)

sodium chloride

Intervention Description

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.

Primary Outcome Measure Information:

Title

The primary outcome is change in fatigue measured by the SSS (Stanford Sleepiness Scale) between groups treated with Anakinra vs. placebo

Description

Fatigue will be measured by using the SSS (Stanford Sleepiness Scale)

Time Frame