跳至主要内容
临床试验/NCT01803568
NCT01803568已完成不适用

Skeletal Muscles, Myokines and Glucose Metabolism

Oslo University Hospital0 个研究点目标入组 31 人开始时间: 2011年9月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
31
主要终点
Change from baseline in gene expression changes in skeletal and adipose tissue

研究概览

简要总结

Normal glucose uptake and metabolism in skeletal muscles are essential to keep blood glucose within normal range and hence, insulin resistance (possibly mediated by inflammatory processes) in skeletal muscle is a major pathogenic factor in type 2 diabetes. Physical activity seems to be of essential importance in the prevention and treatment of type 2 diabetes. Myokines are proteins secreted from skeletal muscle that can execute important biological functions locally in the muscle (paracrine) or in other organs like the brain, heart and pancreas (endocrine). Evidence suggest that several interleukines and other cytokines are secreted by skeletal muscles. In the present project, the investigators will explore the relation between secreted myokines from muscle cells, insulin resistance and glucose metabolism before and after 12 weeks of exercise intervention. Subjects with normal as well as impaired glucose metabolism will be included in the study.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Basic Science
盲法
None

入排标准

年龄范围
40 Years 至 65 Years(Adult, Older Adult)
性别
Male
接受健康志愿者

入选标准

  • Age 40-65 years
  • Nordic ethnicity
  • Non-smoker
  • Either (participants with impaired glucose metabolism): Body Mass Index (BMI) 27-32 kg/m2 and abnormal glucose metabolism, defined as:
  • i. impaired fasting glucose (FPG ≥ 5.6 mmol/L) ii. impaired glucose tolerance (2 h PG ≥7.8 mmol/L) iii. type 2 diabetes (no medication, HbA1c ≤7.5%)
  • Or (controls): BMI 19-25 kg/m2 and normal glucose metabolism and no first degree relatives with type 2 diabetes.

排除标准

  • Subjects having type 1 diabetes or medically treated type 2 diabetes.
  • Systolic blood pressure ≥ 160 mmHg or diastolic blood pressure ≥ 90 mmHg at screening
  • Significant hematological or renal disease or chronic renal impairment, GFR< 50 ml/min.
  • Significant liver disease or ALAT >3x UNL.
  • Chronic inflammatory disease in active phase or long-term use of corticosteroids last 3 months.
  • Use of anti-diabetic agents, lipid lowering drugs, antihypertensive medication, ASA or any other drug not deemed suitable by the study physician.
  • Mental condition (psychiatric or organic cerebral disease), drug or alcohol abuse rendering the subject unable to understand the nature, scope and possible consequences of the study.
  • BMI outside inclusion criteria.
  • Any medical or other condition that in the judgment of the investigator would jeopardize the subject's safety or evaluation of the intervention for efficacy and safety
  • Exercising regularly (>1 times pr week)

结局指标

主要结局

Change from baseline in gene expression changes in skeletal and adipose tissue

时间窗: Baseline and after 12 weeks, and before, 0 hr and 2 hours after acute exercise

Changes from baseline in plasma/serum levels of selected proteins

时间窗: Baseline and after 12 weeks, and before, 0 hr and 2 hour

次要结局

  • Change from baseline in insulin sensitivity(Before and after 12 weeks of exercise)
  • Changes in baseline from maximal oxygen uptake VO2 max(Before and after 12 weeks)
  • Changes from baseline in muscle strength(Before and after 12 weeks)
  • Changes from baseline in body composition(Before and after 12 weeks)
  • Changes from baseline in heart frequency(Before and after 12 weeks)

研究者

发起方
Oslo University Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Kåre Inge Birkeland

Professor

Oslo University Hospital

相似试验