NCT00325559已完成不适用
The Effect of Hyperglycaemia on Local Energy Stores in the Working Muscle in Patients With Type 1 Diabetes Mellitus
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Paired difference in the time to complete a time trial corresponding to 5 km cycling between euglycaemia and hyperglycaemia
研究概览
简要总结
This study aims at investigating the effect of hyperglycaemia on physical performance and local energy stores in the muscle in patients with type 1 diabetes mellitus under exercise conditions.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 盲法
- Single
入排标准
- 年龄范围
- 20 Years 至 40 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Aged from 20 to 40 years
- •Patients with type 1 diabetes mellitus lasting for at least 5 years (C-Peptide ≤ 0.3 nmol/l in the presence of a plasma glucose level ≥ 7 mmol/L, indicating insulin dependence)
- •Insulin delivery by CSII (continuous subcutaneous insulin infusion) for at least 6 months
- •Acceptable to good metabolic control, reflected by an HbA1c 5-8%
- •Normal insulin sensitivity, reflected by a daily insulin requirement of 0.3-1.0 U/kg body weight
- •minimum 30' of moderate exercise 3 times per week
- •BMI in the range of 18-25 kg/m2
排除标准
- •Chronic complications of diabetes:
- •Microalbuminuria (Mogensen nephropathy stadium ≥ III)
- •Sensory neuropathy (vibration better than 5/8 at the metatarsophalangeal articulation of digitus I)
- •Proliferating retinopathy
- •No history of macro-vascular complications
- •Clinically relevant autonomous neuropathy
- •Abnormal thyroid function
- •Major depression, psychosis and other severe personality disorders, claustrophobia
- •Active neoplasia
- •Contraindications to exposure to a 1.5 T magnetic field (pace-makers, osteosynthetic material, etc.)
- •Abnormal liver or renal function (creatinine > 130 µmol/L; ASAT and ALAT > 3 times the upper reference limit)
- •Excessive alcohol consumption (>60g/d) or drug-abuse
- •Refusal to give written informed consent
- •Participation in another study
- •Patients, who are not suitable for the study according to the study physician
结局指标
主要结局
Paired difference in the time to complete a time trial corresponding to 5 km cycling between euglycaemia and hyperglycaemia
次要结局
- Rate of glucose infusion
- Serum insulin levels
- Serum glucose levels
- Pretest diary data
- Oxidation of endogenous glucose
- Serum lactate levels during the exercise test
- Amino acid oxidation
- IMCL content during exercise in the working muscle
- Fat oxidation (calculated via tracer and via RER)
- Total glucose oxidation
- Rate of appearance of glucose
- Rate of disappearance of glucose
- Muscle glycogen content during exercise in the working muscle (pre test vs. post test), in euglycaemia and hyperglycaemia respectively (All following endpoints are paired differences (euglycaemia vs. hyperglycaemia) of paired differences (pre
- Oxidation of exogenous glucose
- Rate of perceived exertion
- Serum free fatty acid concentration
- Time to achieve hyperglycemia during clamp
研究者
研究点 (2)
Loading locations...
相似试验
已完成
不适用
Hyperglycemia and Exercise.Aerobic ExerciseGlucose Metabolism Disorders (Including Diabetes Mellitus)HyperglycemiaNCT03284216University of Birmingham12
进行中（未招募）
不适用
Studies on the effect of hyperglycemia on the structure of the fibrin-gel and on the glycosylation of fibrin , and in what way the use of acetylsalicylic acid may interfere with this effect. - Effect of ASA on the fibrin-gel.Patients with type 1 diabetes, not on ASA for the last 6 months, without a history of bleeding disorder and with a normal trobocyte count.EUCTR2005-005723-34-SEDept of Medicine
已完成
不适用
Pathophysiological aspects of hyperglycemia in children with meningococcal sepsis and septic shockMeningococcal sepsisInfections and InfestationsMeningococcal infectionISRCTN68283215Erasmus Medical Centre, Sophia Children?s Hospital (Netherlands)80
终止
不适用
The Association Between Peri-Operative Hyperglycemia and Major Morbidity and MortalityHyperglycemiaNCT00487162University of Medicine and Dentistry of New Jersey56
已完成
不适用
Hyperglycemia and Mitochondrial Function in The Endothelium of HumansDiabetesHyperglycemiaNCT02682342Medical College of Wisconsin35