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Clinical efficacy and mechanism of Empagliflozin in the treatment of patients with new-onset type 2 diabetes and risk factor for atherosclerotic cardiovascular disease

Clinical efficacy and mechanism of Empagliflozin in the treatment of patients with new-onset type 2 diabetes and risk factor for atherosclerotic cardiovascular disease

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1800018825
Enrollment
Unknown
Registered
2018-10-11
Start date
2018-11-01
Completion date
Unknown
Last updated
2019-10-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

patients with new-onset type 2 diabetes and risk factor for atherosclerotic cardiovascular disease

Interventions

Group 1:Empagliflozin

Sponsors

Henan Provincial People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Patients with type 2 diabetes without hypoglycemic agents; 2. Aged between 18 to 70 years old; 3. HbA1c between 6.5% to 13%; 4. With one of atherosclerotic cardiovascular disease as following: (1) Systolic pressure=140mmHg or diastolic pressure=90mmHg; (2) Older than 50 years old in male or 60 years old in female; (3) LDL-C=2.6mmol/L or TG=2.3mmol/L or HDL-C=0.88 mmol/L; (4) BMI=28Kg/m2; (5) Urine microalbumin/creatinine >30; (6) Ankle brachial pressure index (ABI)=0.9 in either side; 5. There is a fixed residence for at least 5 years; 6. In good ability of memory and activity; 7. Be in good mental health and self-reliant; 8. With an informed consent form.

Exclusion criteria

Exclusion criteria: 1. With positive diabetes antibody (IAA,ICA, or GAD), or diagnosed type 1 diabetes; 2. With severe diabetes complications, e.g. leg ulcers, severe liver and kidney damage, severe neurological diseases and severe retinopathy; 3. Blood pressure=180/110mmHg or total cholesterol=6.2mmol/L; 4. Antibiotics used in the past 3 months for 3 days or more; 5. Pregnancy or planning to become pregnant 6. Intemperance (drinking more than 5 times in one week and drinking more than 100g spirit, 250g rice wine or 5 bottles of beer); 7. Patients diagnosed with severe mental disease in 6 months; 8. Received drug therapy aim at the following diseases, e.g. cholecystitis, peptic ulcer, urinary tract infection, acute pyelonephritis, urocystitis or hyperthyreosis; 9. had gastrointestinal surgery, except for appendicitis and hernia surgery; 10. Patients with severe liver diseases such as chronic, persistent hepatitis or cirrhosis, or HBsAg positive, or liver dysfunction (Serum alanine transaminase and oxaloacetic transaminase 2.5 times than normal); 11. Patients with IBD or Cushing syndrome; 12. Patients with abnormal pituitary function; 13. Patients with severe diseases like cancer, CVD, AMI, or stroke et al; 14. Patients with infectious diseases such as tuberculosis and AIDS et al; 15. Physical disability, or other causes of life can not be self-care, can not be clearly recalled, answer the question of the person; 16. Anemia: HbA1c less than 10g/dl; 17. Physical disability or self-care disability or disability of recalling clearly and answering questions caused by any other reasons; 18. Without enough time taking part in this project; 19. participateing in other research program.

Design outcomes

Primary

MeasureTime frame
Glycosylated Hemoglobin;

Secondary

MeasureTime frame
weight;blood pressure;carotid ultrasound;cardiac ultrasound;

Countries

China

Contacts

Public ContactHuijuan Yuan

He'nan Provincial People's Hospital

lmls3712@163.com+86 13513891997

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026