Rationale and design of the AdRem study: evaluating the effects of blood pressure lowering and intensive glucose control on vascular retinal disorders in patients with type 2 diabetes mellitus.
The ADVANCE Retinal Measurements (AdRem) Study is a large intervention study evaluating the effects of target driven intensive glucose control and placebo controlled blood pressure lowering on retinal vascular changes. AdRem is a sub-study of the ADVANCE Study (Action in Diabetes and Vascular disease), a 2x2 factorial randomized controlled trial with an ACE inhibitor-diuretic combination (perindopril-indapamide) and a gliclazide MR-based regimen in patients with type 2 diabetes mellitus. The AdRem study is based on seven-field stereoscopic retinal photographs of both eyes. These are taken within 3 months after randomization in ADVANCE (baseline), at the biennial and at the final visit. The primary outcome is progression of two or more steps in ETDRS classification. Secondary outcomes include progression of retinal vascular lesions and distortion of retinal vascular geometry. Retinal photographs are made on film and digitized at a central laboratory. The AdRem study uses fully digitized quality control and grading. Between August 2002 and January 2004 1978 patients were included in the AdRem study, from 39 centers in 14 countries. Approximately 85% comply with the strict AdRem quality requirements. Publication of the results is expected in early 2008. The AdRem study is designed to provide reliable evidence on the effects of intensive glucose control and blood pressure lowering on both diabetic retinopathy and abnormalities of retinal vasculature in patients with type 2 diabetes mellitus.
Stolk
Ronald P
RP
Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht, The Netherlands. R.P.Stolk@epi.umcg.nl
Vingerling
Johannes R
JR
Cruickshank
J Kennedy
JK
Hughes
Alun D
AD
Stanton
Alice
A
Juming
Lu
L
Patel
Anushka
A
Thom
Simon A McG
SA
Grobbee
Diederick E
DE
D000959:Antihypertensive Agents / Q000627:therapeutic use; D001786:Blood Glucose; D002986:Clinical Trials as Topic / Q000379:methods*; D003924:Diabetes Mellitus, Type 2 / Q000188:drug therapy*; D003930:Diabetic Retinopathy / Q000517:prevention & control*; D006801:Humans; D006973:Hypertension / Q000188:drug therapy*; D007004:Hypoglycemic Agents / Q000627:therapeutic use; D010781:Photography / Q000379:methods; D016032:Randomized Controlled Trials as Topic / Q000379:methods*; D012107:Research Design; D012171:Retinal Vessels / Q000473:pathology; D013057:Spectrum Analysis / Q000379:methods
D000959:Antihypertensive Agents; D001786:Blood Glucose; D007004:Hypoglycemic Agents