Effects and Safety of GUideline Algorithm Based Intervention on CaRdiovascular and Renal Outcomes in Elderly Diabetic Patients With High Cardiovascular Risk in the Community- A Cluster Randomized Controlled Trial (GUARD-Community Study)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 5,600
- 试验地点
- 13
- 主要终点
- Primary Outcome of Phase 1: Comprehensive management effect of various cardiovascular risk factors in T2D，meeting control targets for a combination of A1c, BP, LDL-C.
研究概览
简要总结
The Effects and Safety of Diabetic GUideline Algorithm Implementation in the Community (GUARD-Community) study is a 2-arm, cluster-randomized control trial to evaluate the effect and safety of guideline algorithm intervention performed by primary care physicians on cardiovascular and renal outcomes in elderly patients with high risk in community.
详细描述
Diabetes is an important public health concern. Elderly diabetic patients are characterized by a long duration and complications, including chronic kidney disease and/or cardiovascular disease. In the past 30 years, the guidelines of CDS, EASD or ADA have been frequently updated. The latest guideline on pharmacological algorithm recommend that patients with cardiovascular, renal disease or very high/high CV risk patients should be treated with anti-diabetic drugs presenting target organ protection, including SGLT2i and GLP1RA. And the guideline recommend comprehensive control of the cardiovascular risk factors, such as hypertension and dyslipidemia.
This GUARD-Community study is a community based cluster-randomized controlled trial and will enroll 5600 or more participants in more than 120 clusters aged ≥ 65 years with T2DM and complicated with high/very high cardiovascular risk factors . The trial will evaluate the the effects and safety of intensive "Guideline" algorithm implementation on CVD and renal outcomes. The primary hypothesis is that guideline algorithm intervention implemented by primary care physicians will significantly reduce the risk of 4-point MACE (comprised of cardiovascular death, nonfatal myocardial infarction, nonfatal stroke or hospitalization of heart failure) rates. In Phase 1 study, the control of blood sugar, blood pressure and lipids will be evaluated at 18 months after intervention. In Phase 2 study, the CVD and renal outcomes will be evaluated at 3 years. The study will last for 4 years.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
Outcome Assessment Committee members will be blinded to outcome assignment.
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •①Males or females aged 65 and above (≥65) receive treatment from the local community health service center;
- •②Diagnosed type 2 diabetes (ADA criteria):
- •A. Typical symptoms of diabetes + random blood sugar ≥ 11.1mmol/L;
- •B. Fasting blood glucose (FPG) ≥ 7.0mmol/L (fasting blood glucose is defined as no caloric intake within 8 hours);
- •C. Oral glucose tolerance test 2h blood glucose (OGTT) ≥ 11.1mmol/L (2h after meal);
- •D. have been treated with antidiabetic drugs;
- •Each blood sugar test must be repeated to confirm the diagnosis;
- •③Complicated with chronic kidney disease and/or very high/high risk of cardiovascular disease, meet any one of the following:
- •A. ASCVD, including coronary heart disease, cerebral infarction, peripheral vascular disease;
- •B. Or target organ damage (albuminuria, renal impairment with eGFR ≥ 30 ml/min/1.73m2, left ventricular hypertrophy or retinopathy);
- •C. ≥ 3 major risk factors (age ≥ 65 years old, hypertension, dyslipidemia, smoking, obesity );
- •D. Diabetes duration ≥ 10 years, with any one traditional cardiovascular risk factor such as advanced age, obesity, smoking, sedentary, family history of cardiovascular disease, hypertension, abnormal lipid metabolism.
排除标准
- •①Pregnant women or women planning to become pregnant;
- •②eGFR<30 mL/min/1.73m2 (CKD-EPI formula);
- •③Patient cannot be followed up for 36 months (due to health condition or migration);
- •④Unwilling or unable to sign the informed consent;
- •⑤Type 1 diabetes;
结局指标
主要结局
Primary Outcome of Phase 1: Comprehensive management effect of various cardiovascular risk factors in T2D，meeting control targets for a combination of A1c, BP, LDL-C.
时间窗: 18 months since randomization
The proportion of participants with HbA1C\<7.0%, blood pressure\< 130/80 mm Hg，LDL-c\<1.8mmol/L at very high CV risk or \<2.6mmol/L at high CV risk.
Primary Outcome of Phase 2: Composite of 3P MACE and hospitalization for heart failure.
时间窗: 3 years since randomization
Time to occurrence of cardiovascular and cerebrovascular death, non-fatal myocardial infarction, non-fatal Stroke, hospitalization for heart failure.
次要结局
- Secondary Outcome of Phase 1: Mean HbA1C changes(18 months since randomization)
- Secondary Outcome of Phase 1: Mean systolic and diastolic pressure changes(18 months since randomization)
- Secondary Outcome of Phase 1: Mean LDL-c changes(18 months since randomization)
- Secondary Outcome of Phase 2: Cardiorenal composite endpoint(3 years since randomization)
- Secondary Outcome of Phase 2: Changes of myocardial ischemia in electrocardiogram (ECG)(3 years since randomization)
- Secondary Outcome of Phase 2: Albuminuria regression(3 years since randomization)
- Secondary Outcome of Phase 2: Changes in cognitive function(3 years since randomization)
- Secondary Outcome of Phase 1: Glycemic control rate(18 months since randomization)
- Secondary Outcome of Phase 1: Adherence to guideline algorithm medication recommendation rate(18 months since randomization)
- Secondary Outcome of Phase 2: Incident or worsening nephropathy(3 years since randomization)
- Secondary Outcome of Phase 2: 3P MACE(3 years since randomization)
- Secondary Outcome of Phase 2: New onset of macroalbuminuria.(3 years since randomization)
- Secondary Outcome of Phase 2: New onset of albuminuria(3 years since randomization)
- Secondary Outcome of Phase 2: Albuminuria progression(3 years since randomization)
- Secondary Outcome of Phase 2: Changes in the ratio of patients with normal or abnormal urine protein at the end of the study(3 years since randomization)
- Secondary Outcome of Phase 2: Slope of eGFR decline(3 years since randomization)
- Secondary Outcome of Phase 2: Retinopathy changes(3 years since randomization)
- Secondary Outcome of Phase 2: Body weight change(3 years since randomization)
- Secondary Outcome of Phase 2: Changes of fatty liver prevalence(3 years since randomization)
- Secondary Outcome of Phase 2: Changes in beta-cell function(3 years since randomization)
- Secondary Outcome of Phase 2: The FRAIL scale(3 years since randomization)
- Secondary Outcome of Phase 2: All-cause death(3 years since randomization)
研究者
Xiaoying Li
Chief of Endocrinology Department
Shanghai Zhongshan Hospital