ISRCTN16418171终止未知
Effect of exercise on insulin resistance: A multi-centre randomized interventional trial
Alere San Diego Inc. (USA)0 个研究点目标入组 30 人开始时间: 2014年7月21日最近更新:
试验速览
- 阶段
- 未知
- 状态
- 终止
- 发起方
- 入组人数
- 30
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Aged 18 to 75 years
- •2. Meets one of the three diagnostic criteria listed below (based on screening results or recorded result within one week of enrollment)
- •2.a. Fasting plasma or whole blood glucose (fasting defined as no caloric intake for at least 8 hours): 100 ¡Ü 125 mg/dL (6.0-6.9 mmol/L)
- •2.b. HbA1c of 5.7% - 6.4% (39 - 46 mmol/mol)
- •2.c. 2-hour plasma glucose of 140-199 mg/dL (7.8-11.0 mmol/L) during an OGTT (as described by the WHO using a glucose load of 75 g anhydrous glucose dissolved in water)
- •3. No clinically significant adverse exercise response during the maximal graded exercise test
排除标准
- •1. Weight loss diet program or weight change (>10%) within the past 6 months
- •2. Daily physical activity of >10,000 steps per day (as measured during the interval between visits 1 and 2)
- •3. Participates in deliberate structured exercise
- •4. Pregnant or intending to become pregnant
- •5. Cognitive or intellectual disability that prevents subject from providing informed consent or following protocol instructions.
- •6. Unwillingness to participate in all study procedures
- •7. Inability to give blood through multiple venous phlebotomies or to have an intravenous catheter
- •8. BMI greater than 40 kg/m2
- •9. Concurrent participation in another lifestyle modification trial
- •10. Diagnosis of diabetes based on any one of the following criteria:
- •10.a. Fasting plasma or whole blood glucose ¡Ý 126 mg/dL (7 mmol/L)
- •10.b. HbA1c of >6.5% (>47 mmol/mol)
- •10.c. 2-hour plasma glucose ¡Ý 200 mg/dL (11.1 mmol/L) during an OGTT
- •11. Any pre-existing or newly discovered medical condition that is deemed likely to put the subject at risk of injury during this trial. This may include but is not limited to:
- •11.a. Clinically relevant vascular or cerebrovascular event (e.g. stroke, recurrent transient ischemic attack (TIA), deep venous thrombosis or intracardiac thrombi, clinically significant edema within the previous 6 months
- •11.b. Current use of anti-psychotic, anti-convulsant, anti-coagulant, sedative medication, or cognition-enhancing medications
- •11.c. Current use of beta blockers (beta-adrenergic blocking agents)
- •11.d. Current or previous use (within the past year) of the following medications: diabetes related medications or insulin; metformin; growth hormone; glucagon; dipeptidyl peptidase-4(DPP-4) inhibitors (saxagliptin, stigagliptin); glucagon-Like Peptide-1(GLP-1) mimetics (exenatide, liraglutide); sulfonylurea medication or other potential confounding medications
- •11.e. Medical conditon which predetermines insulin resistance (e.g. Marfan syndrome / severe Polycystic ovary syndrome (PCOS) / Cushing syndrome etc.).
- •11.f. Fasting triglycerides > 1000 mg/dL
研究者
相似试验
已完成
不适用
The effect of aerobic exercise on insulin resistance in Type 2 DiabetesType 2 Diabetes.Non-insulin-dependent diabetes mellitusIRCT201201258822N1Mazandaran University of Medical Sciences50
已完成
不适用
Effect of high intensity exerice on insulin resistance.oneJPRN-UMIN000003137Graduate School of Medicine, Tohoku University75
Unknown
3 期
Exercise Training in Type 2 Diabetes MellitusCTRI/2022/04/041762Gulf Medical University
招募中
不适用
The effect of an exercise program on insulin sensitivity and plasma glucose levels in women at risk for gestational diabetes mellitus.bloodsugar levelinsulin sensitivity1001842410026908Gestational diabetes mellitusNL-OMON33591Vrije Universiteit Medisch Centrum160
终止
不适用
Effect of Exercise on Insulin ResistancePrediabetic StateNCT01941277Alere San Diego3