title: Vitamin D analogue therapy, cardiovascular risk and kidney function in people with Type 1 diabetes mellitus and diabetic nephropathy: a randomized trial.
abstract: OBJECTIVE
  To evaluate the effects of therapy with the vitamin D analogue paricalcitol on markers of cardiovascular risk and kidney function in people with Type 1 diabetes mellitus and diabetic nephropathy.
  
  
  METHODS
  In a double-blind, randomized placebo-controlled, crossover trial, 48 participants on stable renin angiotensin aldosterone system blockade and diuretics were assigned, in random order, to 12 weeks of paricalcitol and 12 weeks of placebo therapy, separated by a 4-week washout period. Primary and secondary endpoints were changes in plasma N-terminal probrain natriuretic peptide and urinary albumin excretion rate obtained before and after each intervention. Glomerular filtration rates were estimated and measured ((51) Cr-EDTA plasma clearance glomerular filtration rate) after each intervention.
  
  
  RESULTS
  The mean (sd) age of the participants was 57 (9) years, the baseline geometric mean (95% CI) urinary albumin excretion rate was 148 (85-259) mg/24 h, the mean (sd) HbA1c was 70 (9) mmol/mol [8.6 (3)%], the mean (sd) estimated glomerular filtration rate was 47 (15) ml/min/1.73 m(2) and the mean (sd) 24-h blood pressure was 135 (17)/74 (10) mmHg. Compared with placebo therapy, vitamin D analogue therapy had no significant effect on plasma N-terminal probrain natriuretic peptide concentration (P = 0.6), urinary albumin excretion rate was reduced by 18% (P = 0.03 for comparison), estimated glomerular filtration rate was reduced by 5 ml/min/1.73 m(2) (P < 0.001) and measured glomerular filtration rate was reduced by 1.5 ml/min/1.73 m(2) (P = 0.2).
  
  
  CONCLUSIONS
  Paricalcitol therapy did not affect plasma N-terminal probrain natriuretic peptide concentration in people with Type 1 diabetes and diabetic nephropathy; however, the urinary albumin excretion rate was significantly lowered.
authors.affiliation: Steno Diabetes Centre, Gentofte, Denmark.
authors.forename: C
authors.initials: C
authors.lastname: Joergensen
authors.forename: L
authors.initials: L
authors.lastname: Tarnow
authors.forename: J P
authors.initials: JP
authors.lastname: Goetze
authors.forename: P
authors.initials: P
authors.lastname: Rossing
mesh_terms: D000328:Adult; D000368:Aged; D000419:Albuminuria / Q000453:epidemiology / Q000652:urine; D015415:Biomarkers / Q000097:blood; D002318:Cardiovascular Diseases / Q000097:blood / Q000453:epidemiology*; D018592:Cross-Over Studies; D003922:Diabetes Mellitus, Type 1 / Q000150:complications*; D003928:Diabetic Nephropathies / Q000503:physiopathology / Q000517:prevention & control* / Q000652:urine; D018450:Disease Progression; D004311:Double-Blind Method; D004872:Ergocalciferols / Q000494:pharmacology* / Q000627:therapeutic use*; D005260:Female; D005919:Glomerular Filtration Rate / Q000187:drug effects / Q000502:physiology; D006020:Glycopeptides / Q000097:blood; D006801:Humans; D015994:Incidence; D007668:Kidney / Q000187:drug effects* / Q000503:physiopathology; D008297:Male; D008875:Middle Aged; D020097:Natriuretic Peptide, Brain / Q000097:blood; D010446:Peptide Fragments / Q000097:blood; D012307:Risk Factors; D014807:Vitamin D / Q000031:analogs & derivatives*
chemical_list: D015415:Biomarkers; D004872:Ergocalciferols; D006020:Glycopeptides; D010446:Peptide Fragments; C048197:copeptins; C109794:pro-brain natriuretic peptide (1-76); D020097:Natriuretic Peptide, Brain; D014807:Vitamin D; C084656:paricalcitol