Type 2 Diabetes Clinical Trial
Official title:
Role of Interleukin-1 in the Regulation of Muscle Derived Interleukin-6 During Exercise
Aim: Evaluate the regulation of muscle derived Interleukin-6 (IL-6)during exercise and in
particular whether it is regulated by the Interleukin-1 (IL-1) system.
Rationale: It has been shown that IL-1 antagonism improves glycemia and insulin secretion in
patients with type 2 Diabetes. However, IL-1 antagonism also decreases IL-6 levels. The
effect if IL-6 on the glucose metabolism has been unclear in the past and subject to intense
debate, with recent evidence indicating a beneficial role in regulating glucose metabolism.
However little is known about regulation of muscle-induced IL-6 produced during exercise. It
is therefore our aim to investigate whether exercise induced increases in IL-6 are dependent
on the IL-1 system. If IL-1 antagonism does decrease IL-6 and along with it, the beneficial
potential of IL-6, this may require additional medication like IL-6 substitution or
dipeptidyl peptidase-IV (DPP-IV)antagonists.
In addition, the investigators will assess the effect of IL-1 antagonism on insulin and
Glucagon like peptide-1 (GLP-1) secretion as well as muscle soreness,fatigue and vascular
function in response to an acute exercise bout.
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.
;
Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Basic Science
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