ACTRN12608000286347招募中未知
A randomised trial of exercise training versus standard guideline-based care on vascular function in subjects with newly-diagnosed type 2 diabetes mellitus
Centre for Clinical Research & effective practice (CCRep)0 个研究点目标入组 32 人开始时间: 2008年6月4日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 招募中
- 发起方
- 入组人数
- 32
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
- Prevention
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 30 Years 至 59 Years（—）
- 性别
- All
入选标准
- •Patients to be included in this protocol must:
- •1. Be aged >30 years and =60 years
- •2. Have type 2 diabetes mellitus (maximum of 2 years since diagnosis) in accordance with American Diabetes Association criteria treated with diet or metformin oral hypoglycemic medication with an HbA1c 6.5-10% at baseline.
- •3. Provide written informed consent to participate in the study
排除标准
- •A patient with any of the following conditions prior to randomisation will not be enrolled into the study:
- •1. Diabetic nephropathy (urine albumin creatinine ratio (ACR) >200mg/mmol)
- •2. Known non-diabetic renal disease as indicated by haematuria, active urinary sediment or casts
- •3. Serum creatinine >150 µmol/L in men and ?130 µmmol/L in women
- •4. Morbid obesity with body mass >160kg
- •5. Abnormal baseline Electrocardiogram (ECG), or inducible ischaemic changes on baseline exercise tolerance test
- •6. Pregnant, nursing a child, or planning a pregnancy at the time of this study
- •7. History of type 1 diabetes defined as age of onset <20 years and/or history of continuous treatment with insulin since diagnosis
- •8. History of cigarette smoking, drug or alcohol abuse
- •9. Co-morbid conditions that are likely t o affect ability to participate in an exercise program:
- •a. Severe chronic obstructive pulmonary disease (COPD) as evidenced by hospitalization for decompensation within 6 months of randomization, chronic treatment with oral steroids, or a resting oxygen saturation (SAO2) <90 mm Hg
- •b. Congestive heart failure (CHF) corresponding with New York Heart Association (NYHA) Class II, III and IV or an N-terminal pro-brain natriuretic peptide (NT-proBNP) level >350
- •c. Severe ischaemic heart disease (IHD) with acute coronary event, and/or coronary artery bypass graft (CABG), and/or percutaneous coronary intervention (PCI) in the previous 60 days.
- •d. Severe peripheral vascular disease
- •e. Severe arthritic disease of the feet, knees, hips, or lower spine
- •f. Severe liver disease with icterus and plasma bilirubin =60 µmmol/L, plasma transaminase = 3-fold upper limit of normal, albumin <30 g/L or coagulopathy
- •g. Hematological disorders including hemoglobin <110 g/L or platelet count < 80,000/mm3
- •10. Gastrointestinal bleeding in the previous 60 days,
- •11. Malignancy other than basal cell carcinoma.
- •12. Any other disease or condition which in the opinion of the investigator could make them unsuitable for entry.
研究者
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