Intervention using vitamin D for elevated urinary albumin in type 2 diabetes mellitus (IDEAL-2 Study): study protocol for a randomised controlled trial

Trials

IDEAL-2 Study Team¹  Shahrad Taheri²  Muhammad Asim³  Omar Fituri³  Hassan al Malki³  Phyllis August⁴  Manikkam Suthanthiran⁴ 

[1] ;Department of Medicine, Weill Cornell Medicine – Qatar;Department of Nephrology, Hamad Medical Corporation;Joan and Sanford I. Weill Department of Medicine, Weill Cornell Medicine – New York;

关键词: Type 2 diabetes mellitus;    Diabetic kidney disease;    Albuminuria;    Angiotensin converting enzyme inhibitor;    Angiotensin receptor blocker;    Vitamin D;   

DOI  :  10.1186/s13063-018-2616-5

来源: DOAJ

【 摘 要 】

Abstract Background The prevalence of type 2 diabetes mellitus (T2DM) is increasing worldwide. T2DM is associated with serious macro- and microvascular complications. In particular, diabetic kidney disease (DKD), which begins with excessive urinary albumin excretion, has a significant impact on affected individuals and is costly to healthcare services. Inhibition of the renin–angiotensin–aldosterone system (RAAS) with angiotensin converting enzyme inhibitors (ACEI) or angiotensin receptor blockers (ARB) significantly reduces albuminuria in diabetes, but this effect is not observed in all those treated. Active vitamin D analogues have been observed to be reno-protective through inhibition of RAAS in animal and human studies. Therefore, it can be hypothesised that an active vitamin D analogue will have an additional benefit to ACEI/ARB treatment for albuminuria reduction in DKD. Methods The planned study is an ongoing non-blinded randomised controlled parallel-group trial examining the impact, in individuals with T2DM, of the addition of bioactive vitamin D (calcitriol) to RAAS inhibition treatment using ACI or ARB on urinary albumin excretion over a period of 26 weeks. The primary outcome measure is the urinary albumin creatinine ratio. It is planned for the study to recruit 320 participants. Other outcome measures of interest include 24-h urine albumin (24 h UA) excretion, estimated glomerular filtration rate (eGFR), blood pressure and quality of life. Safety will be assessed throughout. Discussion If the addition of calcitriol to RAAS inhibition with ACEI or ARB safely results in a significant reduction in albuminuria, the study adds to the body of evidence supporting a role for vitamin D in reno-protection, will inform clinical practice and could result in significant reduction of healthcare costs associated with DKD. Trial registration ISRCTN, ISRCTN86739609. Registered on 7 June 2017. ClinicalTrials.gov, NCT03216564. Registered on 13 July 2017.

【 授权许可】

Unknown