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Role of Interleukin-1 in the Regulation of Muscle Derived Interleukin-6 During Exercise

20 Years
50 Years
Open (Enrolling)
Type 2 Diabetes

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Trial Information

Role of Interleukin-1 in the Regulation of Muscle Derived Interleukin-6 During Exercise

This is a randomized placebo-controlled, double blind, cross-over, proof-of-concept study.

The study will consist of one screening visit followed by 3 study visits. During the first
two study visits, the subjects (20 apparently healthy, lean men) will perform a submaximal
exercise bout on a treadmill for 60 minutes. Subjects will be randomly assigned into two
groups consisting each of 10 subjects receiving study medication in a double-blinded,
crossed over manner.

Inclusion Criteria:

- male

- non-smoking

- apparently healthy

- BMI > 18 and < 26kg/m2

- Age 20-50 years

- Regular exercise including a minimum of two runs weekly of a total duration of > 2h

- 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), sterilization (e.g., tubal ligation or a
monogamous relationship with a vasectomized partner), and abstinence.

Exclusion Criteria:

- Clinical signs of infection in the week before inclusion or history of infection
during the last 3 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 for men and 1.4mg/dL for woman)

- Liver disease (transaminases > 2x upper normal range)

- Heart disease

- Pulmonary disease

- Inflammatory disease

- History of carcinoma

- History of tuberculosis

- Alcohol consumption > 40g/d

- Known allergy to Kineret

- 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 enrollment or within 5
half-lives of the investigational drug, whichever is longer

- Subject refusing or unable to give written informed consent

Type of Study:


Study Design:

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Basic Science

Outcome Measure:


Outcome Time Frame:

Change of IL6 during exercise stimulation at baseline compared to change of IL6 during exercise stimulation at day 7

Safety Issue:


Principal Investigator

Marc Y Donath, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Basel


Switzerland: Swissmedic

Study ID:

MUSIL 294/10



Start Date:

December 2011

Completion Date:

Related Keywords:

  • Type 2 Diabetes
  • IL-1
  • IL-6
  • Inflammation
  • Diabetes Mellitus, Type 2