ACTRN12620001129976招募中未知
Efficacy of a Structured Weight Management Program for achieving Diabetes REmission in a primary care setting in Australia – Diabetes Remission Clinical Trial-Australia(DiRECT-Aus Study)
Diabetes NSW & ACT0 个研究点目标入组 250 人开始时间: 2020年10月30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
- 250
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
- Non-randomised trial
- 主要目的
- Treatment
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 20 Years 至 65 Years（—）
- 性别
- All
入选标准
- •Men and women aged 20-65 years, all ethnicities
- •T2DM of duration 0-6 years
- •Body mass index (BMI)>27 kg/m2
排除标准
- •Current insulin use
- •HbA1c greater than 86 mmol/mol (10%) at screening
- •Weight loss of greater than 5kg within the last 6 months
- •Recent eGFR equals 45 ml/min/1.732
- •Substance abuse
- •Known cancer
- •Myocardial infarction within previous 6 months
- •Severe or unstable Heart Failure defined as equivalent to the New York Heart Association (NYHA):
- •A.Grade 3 - marked limitation of physical activity. Comfortable at rest, but less than ordinary activity causes fatigue, palpitation, or breathlessness, and
- •B.Grade 4 - unable to carry out any physical activity without discomfort. Symptoms of cardiac insufficiency at rest. If any physical activity is undertaken, discomfort is increased.
- •Learning difficulties
- •Current treatment with anti-obesity drugs
- •Diagnosed eating disorder or purging
- •Pregnant/ considering pregnancy
- •Patients with unstable mental illness
- •People currently participating in another clinical research trial
- •Allergy to Optifast or any of its ingredients
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