Intervention for High-normal Blood Pressure in Adults With Type 2 Diabetes

Launched by XUEQING YU · Aug 24, 2017

Keywords

ClinConnect Summary

The clinical trial, called IPAD, is studying whether certain blood pressure medications can help adults with type 2 diabetes who have slightly elevated blood pressure (between 120-139 mm Hg systolic and below 90 mm Hg diastolic). The goal is to see if lowering their blood pressure can reduce serious heart and brain problems, like heart attacks and strokes. This study will involve nearly 12,000 participants, who will be followed for about four years. Some will receive intensive treatment to lower their blood pressure to below 120 mm Hg, while others will have their blood pressure controlled to stay below 140 mm Hg.

To take part in this trial, participants need to be between 45 and 79 years old, have type 2 diabetes, and have the specified blood pressure range. However, those with poorly controlled diabetes, certain heart conditions, or other severe health issues won't be eligible. Participants can expect regular check-ups and monitoring of their blood pressure and diabetes management throughout the study. This trial aims to provide valuable information on how blood pressure treatment can improve health outcomes for people with diabetes.

Gender

ALL

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.