Type 2 Diabetes Clinical Trial
— GUARDOfficial title:
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)
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.
Status | Recruiting |
Enrollment | 5600 |
Est. completion date | November 30, 2026 |
Est. primary completion date | November 30, 2026 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 65 Years and older |
Eligibility | Inclusion Criteria: - ?Males or females aged 65 and above (=65) receive treatment from the local community health service center; - ?Diagnosed 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; - ?Complicated 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. Exclusion Criteria: - ?Pregnant women or women planning to become pregnant; - ?eGFR<30 mL/min/1.73m2 (CKD-EPI formula); - ?Patient cannot be followed up for 36 months (due to health condition or migration); - ?Unwilling or unable to sign the informed consent; - ?Type 1 diabetes; |
Country | Name | City | State |
---|---|---|---|
China | Caohu Community Healthcare Center | Suzhou | Jiangsu |
China | Caohu People's Hospital | Suzhou | Jiangsu |
China | Dongqiao Community Healthcare Center | Suzhou | Jiangsu |
China | Health Center of Xiangcheng Tourism Resort | Suzhou | Jiangsu |
China | Huangqiao Community Healthcare Center | Suzhou | Jiangsu |
China | Taiping Community Healthcare Center | Suzhou | Jiangsu |
China | Xiangcheng People's Hospital. | Suzhou | Jiangsu |
China | Xiangcheng Second People's Hospital | Suzhou | Jaingsu |
China | Xiangcheng Third People's Hospital | Suzhou | Jiangsu |
China | Xiangcheng Traditional Chinese Medicine Hospital | Suzhou | Jiangsu |
China | Yangchenghu People's Hospital | Suzhou | Jiangsu |
China | Yuanhe Community Healthcare Center | Suzhou | Jiangsu |
Lead Sponsor | Collaborator |
---|---|
Shanghai Zhongshan Hospital |
China,
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* Note: There are 16 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Health Economics Indicators | Cost-effectiveness analysis: quantification of Incremental Cost Ratio Life Cycle (ICER) and Quality Adjusted Years (QALYs) | 3 years since randomization | |
Other | Changes in cardiovascular risk indicators | Framingham score | 3 years since randomization | |
Other | Serology and urine testing | Biomarkers associated with diagnosis or prognosis: using "omics" screening. | 3 years since randomization | |
Other | Genomics testing | Gene polymorphism testing for drug response or prognosis: using genome-wide association study(GWAS) screening. | 3 years since randomization | |
Other | The time rate of glycemic target range | Continous glucose monitor detection | 3 years since randomization | |
Primary | 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. | 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. | 18 months since randomization | |
Primary | Primary Outcome of Phase 2: Composite of 3P MACE and hospitalization for heart failure. | Time to occurrence of cardiovascular and cerebrovascular death, non-fatal myocardial infarction, non-fatal Stroke, hospitalization for heart failure. | 3 years since randomization | |
Secondary | Secondary Outcome of Phase 1: Glycemic control rate | The proportion of participants with tight glucose control, targeting HbA1c <7.0% | 18 months since randomization | |
Secondary | Secondary Outcome of Phase 1: Mean HbA1C changes | Mean HbA1C changes of participants | 18 months since randomization | |
Secondary | Secondary Outcome of Phase 1: Mean systolic and diastolic pressure changes | Mean systolic and diastolic pressure changes of participants | 18 months since randomization | |
Secondary | Secondary Outcome of Phase 1: Mean LDL-c changes | Mean LDL-c changes of participants | 18 months since randomization | |
Secondary | Secondary Outcome of Phase 1: Adherence to guideline algorithm medication recommendation rate | Use electronic medical recorded prescription and questionnaires to assess the proportion of participants who adhere to guideline recommended medication | 18 months since randomization | |
Secondary | Secondary Outcome of Phase 2: Incident or worsening nephropathy | Time to composite of incident macroalbuminuria (UACR >300 mg/g), a sustained decline in eGFR (decrease in the eGFR of 30% or more to a value of less than 60 when baseline =60ml per minute per 1.73 m2, decrease in the eGFR of 50% or more when baseline <60ml per minute per 1.73 m2)from baseline, or chronic renal replacement therapy, or renal death. | 3 years since randomization | |
Secondary | Secondary Outcome of Phase 2: Cardiorenal composite endpoint | Time to eGFR (CKD-EPI formula) decrease, renal replacement therapy, renal or cardiovascular death | 3 years since randomization | |
Secondary | Secondary Outcome of Phase 2: 3P MACE | Time to events occurence: cardiovascular death, non-fatal myocardial infarction, non-fatal stroke | 3 years since randomization | |
Secondary | Secondary Outcome of Phase 2: New onset of macroalbuminuria. | Time to UACR>300mg/g | 3 years since randomization | |
Secondary | Secondary Outcome of Phase 2: Changes of myocardial ischemia in electrocardiogram (ECG) | Participants number of ECG ischemia demonstration occurence: ST-T segment depression more than 0.1mv in two adjacent leads of ECG compared with baseline, poor R wave progression. | 3 years since randomization | |
Secondary | Secondary Outcome of Phase 2: New onset of albuminuria | Time to UACR increase from <30mg/g to =30mg/g | 3 years since randomization | |
Secondary | Secondary Outcome of Phase 2: Albuminuria progression | Time to albuminuria progression: UACR increased by =30% and grade progression (ie, from normal to micro or macro, or from micro to macro) | 3 years since randomization | |
Secondary | Secondary Outcome of Phase 2: Albuminuria regression | Time to albuminuria regression: UACR grade regression(ie, from macro to micro or normal, or from micro to normal), and the UACR value decreases by more than or equal to 30% | 3 years since randomization | |
Secondary | Secondary Outcome of Phase 2: Changes in the ratio of patients with normal or abnormal urine protein at the end of the study | Rate change of normal or abnormal UACR. Normal means UACR<30mg/g. Abnormal means UACR=30mg/g | 3 years since randomization | |
Secondary | Secondary Outcome of Phase 2: Slope of eGFR decline | Decrease of the eGFR over time | 3 years since randomization | |
Secondary | Secondary Outcome of Phase 2: Retinopathy changes | Occurrence or regression of retinopathy(ETDRS-DRSS) | 3 years since randomization | |
Secondary | Secondary Outcome of Phase 2: Body weight change | Absolute weight change and the percentage change of body weight | 3 years since randomization | |
Secondary | Secondary Outcome of Phase 2: Changes of fatty liver prevalence | Rate change of fatty liver. | 3 years since randomization | |
Secondary | Secondary Outcome of Phase 2: Changes in beta-cell function | Absolute change assessed by HOMA2-%ß method | 3 years since randomization | |
Secondary | Secondary Outcome of Phase 2: Changes in cognitive function | Improvement or progression of cognitive function: The Mini-CogTM scale | 3 years since randomization | |
Secondary | Secondary Outcome of Phase 2: The FRAIL scale | Changes of the simple frailty questionnaire score | 3 years since randomization | |
Secondary | Secondary Outcome of Phase 2: All-cause death | Time to the death due to any cause | 3 years since randomization |
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