A study to test whether spironolactone and dietary nitrate (as beetroot juice) (I) compared to controls, alter blood vessel function, measured as the cardiac-ankle vascular index (O) or as arterial pulse wave velocity (O) in Type 2 diabetes (P): a randomised trial

King's College London (UK)0 个研究点目标入组 126 人开始时间: 2013年1月31日最近更新: 2022年3月21日

试验速览

2017 Abstract results in https://www.ncbi.nlm.nih.gov/pubmed/28935045 abstract (added 04/06/2019) 2020 Results article in https://pubmed.ncbi.nlm.nih.gov/31833569/ (added 24/06/2021) 2021 Results article in https://pubmed.ncbi.nlm.nih.gov/33982797/ (added 11/03/2022)

•1. Anyone (male or female, age 18-80) with ?diagnosed? type 2 Diabetes or at risk of type 2 Diabetes (being overweight BMI >= 27 kg/m2) or found to have impaired glucose tolerance by fasting glycaemia or by glucose tolerance testing will be eligible. Please see under exclusion criteria for limits to this
•2. Participants need to be able to understand the protocol and be willing to comply with it

•1. Ongoing (chronic) illness of any type interfering with patient ability to participate
•2. Major complications restricting mobility including active foot ulceration or amputation may be exclusion criteria, but only if the patient feels they cannot manage
•3. Previous adverse reactions to Spironolactone or Doxazosin. (If patients are already on either of these, we can discuss alternatives)
•4. Renal function by eGFR < 45 mls per minute (approximately - i.e. if one test is around 43 and another is around 46 the average of around 45 is acceptable)
•5. Objective renal function tests for creatinine > 180 umol/l (when eGFR will be < 45 mls/ min).
•6. All other aspects of diabetic control will be acceptable except gross disturbances of glycaemia with HbA1c > 11% and fasting random glucose > 12mmol/l. Those will not be indications to withdraw patients, but only as exclusions for entry (& once improved can become eligible).
•7. For women: being pregnant or breastfeeding for the duration of the study

发起方

King's College London (UK)