Diabetic Nephropathy Clinical Trials

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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)

Status: Recruiting
Location: See all (13) locations...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 65
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
China
Caohu Community Healthcare Center
RECRUITING
Suzhou
Caohu People's Hospital
RECRUITING
Suzhou
Chengyang Community Healthcare Center
RECRUITING
Suzhou
Dongqiao Community Healthcare Center
RECRUITING
Suzhou
Health Center of Xiangcheng Tourism Resort
RECRUITING
Suzhou
Huangqiao Community Healthcare Center
RECRUITING
Suzhou
Taiping Community Healthcare Center
RECRUITING
Suzhou
Xiangcheng People's Hospital.
RECRUITING
Suzhou
Xiangcheng Second People's Hospital
RECRUITING
Suzhou
Xiangcheng Third People's Hospital
RECRUITING
Suzhou
Xiangcheng Traditional Chinese Medicine Hospital
RECRUITING
Suzhou
Yangchenghu People's Hospital
RECRUITING
Suzhou
Yuanhe Community Healthcare Center
RECRUITING
Suzhou
Contact Information
Primary
Xiaoying Li, MD
li.xiaoying@zs-hospital.sh.cn
13651913857
Backup
Xiaomu Li, MD
li.xiaomu@zs-hospital.sh.cn
13661676591
Time Frame
Start Date: 2022-11-21
Estimated Completion Date: 2026-11-30
Participants
Target number of participants: 5600
Treatments
Experimental: Intensive guideline algorithm implementation
SGLT2i or GLP-1RA recommended in priority in subjects at very high/high CV risk. The targets of intervention will be achieved at HbA1C \<7%, blood pressure \<130/80mmHg, LDL-c\<1.8mmol/L at very high CV risk or \<2.6mmol/L at high CV risk patients, antiplatelet as secondary prevention of ASCVD.
Active_comparator: Conventional guideline algorithm implementation
Treatment based on the current approaches implemented by local physicians(primary care physicians). Guideline based education and consults will be conducted to primary care physicians.
Sponsors
Leads: Shanghai Zhongshan Hospital

This content was sourced from clinicaltrials.gov