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

NCT02916355 | Completed

• 1 other identifier: EKNZ BASEC 2016-00816
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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.

Conditions

Adiposity

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (11)

• 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).

  7 to 9 days (change between study day 1 and study day 2)

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

  7 to 9 days (change between study day 1 and study day 2)

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

  7 to 9 days (change between study day 1 and study day 2)

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

  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).

  7 to 9 days (change between study day 1 and study day 2)

Study Arms (2)

Normal BMI

EXPERIMENTAL

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

Drug: Anakinra; Drug: NaCl

Overweight

EXPERIMENTAL

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

Drug: Anakinra; Drug: NaCl

Interventions

Anakinra DRUG

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.

Also known as: Kineret

Normal BMI; Overweight

NaCl DRUG

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.

Also known as: sodium chloride

Normal BMI; Overweight

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Subjects will be excluded from the study if they meet any of the following criteria:
• Night shift workers
• Subjects suffering from sleep disturbances
• 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

Sponsors & Collaborators

• University Hospital, Basel, Switzerland: lead
• Rigshospitalet, Denmark: collaborator

Study Sites (1)

University Hospital Basel, Department of Endocrinology, Diabetes and Metabolism

Basel, CH-4031 Basel, Switzerland

Location

MeSH Terms

Conditions

Obesity

Interventions

Interleukin 1 Receptor Antagonist Protein; Sodium Chloride

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Marc Y Donath, MD

  University Hospital, Basel, Switzerland

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 26, 2016
• First Posted: September 27, 2016
• Study Start: August 1, 2016
• Primary Completion: April 1, 2017
• Study Completion: April 3, 2017
• Last Updated: January 29, 2018

Record last verified: 2018-01

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)