ACTRN12617000552381终止未知
Impact of Exercise Intervention on the Phenome (Metabolism and Predictive Complications) in Well Characterised Pre-diabetes and New Onset Type 2 diabetes Cohorts in China and Australia.
适应症
试验速览
- 阶段
- 未知
- 状态
- 终止
- 入组人数
- 162
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 o limit（—）
- 性别
- All
入选标准
- •BMI greater than or equal to 25 kg/m2 (Non-Asian participants) or BMI greater than or equal to 23 kg/m2 (Asian participants)
- •- Willing to undertake, and have no contraindications to, exercise testing and a program involving high intensity interval training program, resistance training or stretching
- •- Willing to give written informed consent
- •- Adequate understanding of national language
- •- Access to either phone or internet (this is necessary when being contacted by the instructors throughout the duration of the trial)
- •- Maximum weight of 140kg (equivalent MRI habitus limit)
- •- No change in medication or dose for the previous three months
- •- 90 participants at each site will be recruited from each of three glucose groups as defined by any one of the ADA criteria. That is Type 2 Diabetes Mellitus - HbA1c greater than or equal to 6.5%, Fasting Plasma Glucose (FPG) greater than or equal to 7.0 mmol/L, 2h post-Oral Glucose Tolerance Test Plasma Glucose (2hOGTT) greater than or equal to 11.1 mmol/L; Pre-diabetes - one occasion of any of the following in a participants medical history: HBA1c greater than or equal to 5.7% but less than 6.5%, FPG greater than or equal to 5.6 mmol/L but less than 7.0 mmol/L, 2hOGTT greater than or equal to 7.8 mmol/L but less than 11.1 mmol/L; Normal Glucose Profile - HbA1c less than 5.7%; FPG less than 5.6%; 2hOGTT less than 5.6 mmol/L.
排除标准
- •- Untreated dense insensate peripheral neuropathy that contraindicates exercise testing and training (as assessed by medical assessment)
- •- Significant cardiovascular disease including current angina; myocardial infarction or stroke within the past 6 months; heart failure; symptomatic peripheral vascular disease
- •- Active foot ulcer
- •- Musculoskeletal condition affecting ability to undertake exercise testing and training
- •- Self-reported average weekly intake of alcohol >140g per week
- •- Abnormalities noted by medical officer based on the resting ECG suggestive of unrecognised myocardial ischaemia: q waves, or ST wave depression.
- •- Self-reported currently completing >75 min/week high intensity exercise or >150 min/week moderate intensity exercise.
- •- Pregnancy, lactation or plans to become pregnant in the next 2 years.
- •- Claustrophobia or ferrous metal implants/devices which contraindicate MRI scan.
- •- Thiazolidinedione medication
- •- History of Hepatitis B or C which has not been cured
- •- Advanced chronic renal impairment (CKD state 4 or 5 or EFGR< 30)
- •- Cirrhosis
- •- Malignancy which is currently active or in remission for less than five years after last treatment (local basal and squamous cell skin cancer allowed)
- •- Blood donation or transfusion within the past month
- •- Haemoglobin concentration below local laboratory reference values (i.e. anaemia).
- •- Alanine Transaminase (ALT) and/or Apartate Transaminase (AST) >3 times the Upper Limit of Normal (local laboratory reference values)
- •- Any other condition deemed by the study physician that would prevent participation in the trial.
- •- Weight change of greater than or equal to 5% in the past three months.
研究者
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