Intervention for High-normal Blood Pressure in Adults With Type 2 Diabetes (IPAD)
Diabetes Mellitus, Type 2, Adverse Event, Blood Pressure
About this trial
This is an interventional treatment trial for Diabetes Mellitus, Type 2
Eligibility Criteria
Inclusion Criteria:
- irrespective of sex;
- aged between 45 and 79 years;
- with office-measured seated BP 120-139 mm Hg systolic and below 90 mm Hg diastolic;
- diagnosed of type 2 diabetes mellitus (T2DM), currently on diabetic therapy;
- informed consent provided and long-term follow-up possible
Exclusion Criteria:
- poor control of blood glucose, HbA1c > 10.0%
- administration of any antihypertensive medications within 1 month;
- a history of hypoglycemic coma / seizure;
- confirmed diagnosis of type 1 diabetes mellitus;
- alanine-aminotransferase (ALT) or aspartate-aminotransferase (AST) over three times the upper limit of normal;
- estimated glomerular filtration rate < 45 ml/min/1.73m2;
- a history of congestive heart failure with left ventricular ejection fraction < 40%;
- coronary artery disease requiring RAS blockers for secondary prevention;
- acute on-set of stroke within 6 months prior to randomization;
- a ratio of urinary albumin (in mg/L) to urinary creatinine (in g/L) (ACR) ≥ 300 mg/g;
- known contraindications for the active study medications;
- a history of psychological or mental disorder;
- pregnancy or currently planning to have babies or lactation;
- severe diseases such as severe heart diseases;
- an expected residual life span less than 3 years;
- a malignancy that clinical investigators consider as unsuitable to participate;
- currently participating in another clinical trial.
Sites / Locations
- Guangdong General HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Active Comparator
Placebo Comparator
intensive treatment group
standard treatment group
Real antihypertensive agents will be provided for this arm, to decrease systolic BP to lower than 120 mm Hg. In this group, the following study medications will be used: tablets with Allisartan Isoproxil 240 mg (first-line medication); tablets with Amlodipine 5 mg (second-line medication). Treatment will be started with Allisartan 240 mg. If necessary to reach the BP goal, Amlodipine (first 5 mg or then 10 mg daily) will be given in addition. If intolerable side effects occur, first-line medication may be replaced by second-line medication.
In this arm participants are followed up and no medications be used until BP becomes ≥ 140 mm Hg systolic and/or 90 mm Hg diastolic. Medications are determined by investigators in lines with recommendations by current Chinese guidelines to decrease BP to lower than 140 mm Hg systolic and to lower than 90 mm Hg diastolic.