Lowering Blood Pressure in Adults With Type 2 Diabetes

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This trial investigates the effects of intensive antihypertensive treatment in adults with type 2 diabetes who have high-normal blood pressure. It is a randomized, open-label, parallel-designed, multicenter study aiming to recruit nearly 12,000 patients over three years, with a median follow-up of four years. The primary goal is to determine if lowering systolic blood pressure to below 120 mm Hg can reduce the incidence of major cardiovascular and cerebrovascular events by 20%. Participants will receive a combination of medications including Allisartan and Amlodipine to achieve these targets.

Why it matters

Who can join: the full rules

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.

Where it's running

• Guangdong General Hospital
  Guangzhou, Guangdong, China Recruiting

Study contacts

• Principal investigator: Jiyan Chen, MD — Guangdong Provincial People's Hospital
• Study coordinator: Jiyan Chen, MD
• Email: chen-jiyan@163.com
• Phone: 86-13802911148

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Examining blood pressure patterns in people at risk for heart disease

  This study looks at daily blood pressure patterns in people at risk for heart disease, especially those with kidney issues, to see how these patterns might help identify who could benefit from specific treatments.

  Recruiting University of Edinburgh · Edinburgh · NCT04522765

• Proliverenol for liver fat and insulin resistance in type 2 diabetes

  This study tests whether adding Proliverenol to standard diabetes care can improve liver fat and blood sugar control in adults with type 2 diabetes.

  Recruiting Phase 2 Universitas Sriwijaya · Palembang, South Sumatera · NCT07928661

• Whole-Body Vibration Training in Women With Obesity With and Without Type 2 Diabetes

  This study tests whether eight weeks of supervised whole-body vibration training changes ankle muscle activity and walking performance in women with obesity, comparing those with and without type 2 diabetes.

  Recruiting Pamukkale University · Denizli · NCT07924436

• Safety test of NNC9836-0001 in adults with overweight/obesity or type 2 diabetes

  This study tests whether the new medicine NNC9836-0001 is safe and tolerable in adults who are overweight or have type 2 diabetes, compared to placebo.

  Recruiting Phase 1 Novo Nordisk A/S · Neuss · NCT07896109

• RIGHTEST iFree 2 CGM in Pregnant Women With Diabetes

  This study tests the accuracy and safety of the RIGHTEST iFree 2 continuous glucose monitor in pregnant adults with type 1, type 2, or gestational diabetes.

  Recruiting Bionime Corporation · Ulm, Baden-Wurttemberg · NCT07889388

• EloraTZP for weight loss in adults with overweight/obesity and type 2 diabetes

  This trial tests whether a coformulation of eloralintide and tirzepatide helps people with obesity or overweight and type 2 diabetes lose weight compared with tirzepatide alone.

  Recruiting Phase 3 Eli Lilly and Company · Tucson, Arizona and 74 other locations · NCT07881458

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.