Type 2 diabetes and metabolic syndrome
Conditions
Interventions
Dapagliflozin group:Dapagliflozin 10 mg is to be administered orally once daily. The addition of an alternative anti-diabetic agent (excluding another SGLT2 inhibitor) is be permitted 4 weeks after ra
Control group:In the control group, either the dosage of current therapy is to be increased or a concomitant oral glucose-lowering drug (excluding the other SGLT2 inhibitors) is be added 4 weeks after
Sponsors
The First People's Hospital of Xuzhou
Eligibility
Sex/Gender
All
Age
30 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Age 30 - 75 years at the time of giving consent. 2. Patients with type 2 diabetes and inadequate glycemic control (HbA1c >= 7%). 3. Patients with metabolic syndrome. The diagnostic criteria for metabolic syndrome are as follows: (1) Abdominal obesity (central obesity): waist circumference, male >= 90 cm, female >= 85 cm; (2) Hyperglycemia: fasting blood glucose >= 6.l mmol/L or 2 h blood glucose after glucose load >= 7.8 mmol/L, and/or those who have been diagnosed with diabetes and treated; (3) Hypertension: blood pressure >= 130/85 mmHg and/or those who have been confirmed as hypertension and treated; fasting triglycerides >= 1.70 mmol/L; fasting high-density lipoprotein < 1.04 mmol /L. Presence of three or more of the above criteria entitles the physician to diagnose metabolic syndrome. 4. Those who received SGLT2 inhibitors in the past but who had not used SGLT2 inhibitors for at least 12 weeks before signing the consent form. 5. No changes (including new prescriptions) in their antidiabetic, antithrombotic, antihypertensive medication or a therapeutic agent for dyslipidemia for at least 12 weeks before signing their consent form. 6. Able to provide informed consent.
Exclusion criteria
Exclusion criteria: (1) In the perioperative period or with a serious infection or injury. (2) A history of myocardial infarction, angina, stroke, or cerebral infarction. (3) Severe renal dysfunction or end-stage renal failure (estimated glomerular filtration rate 100 U/L). (5) Moderate to severe heart failure (class 3 or worse based on the New York Heart Association Functional Classification). (6) Urinary tract or genital infection. (7) Pregnant, possibly pregnant, nursing, or planning to conceive a child. (8) History of hypersensitivity to the study drug. (9) Present or past history of a malignant tumor. (10) Prohibited to use dapagliflozin. (11) Other ineligibility determined by an investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Carotid intima-media thickness;Incidence of atherosclerotic cardiovascular disease; | — |
Secondary
| Measure | Time frame |
|---|---|
| Glycated hemoglobin;Fasting plasma glucose;Fasting blood insulin;HOMA-ß;Blood pressure;Body mass index;Waist;Liver function;Renal function;UACR;Lipid profile;hs-CRP; | — |
Countries
China
Contacts
Public ContactHu Hao
The First People's Hospital of Xuzhou
Outcome results
None listed