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Zarra, Emanuela (2014) L'effetto a lungo termine dell'€™infusione subcutanea continua di insulina mediante microinfusore comparato alla terapia insulinica multiiniettiva sulla funzione renale, sul tasso di escrezione urinaria di albumina e sulla pressione arteriosa in pazienti con diabete di tipo 1 con microalbuminuria persistente. [Tesi di dottorato]

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Abstract (inglese)

The long-term effect of continuous subcutaneous insulin infusion (CSII) compared to multiple daily insulin injection (MDI) on renal function, albumin excretion rate and blood pressure in type 1 diabetic patients with persistent microalbuminuria.
Summary
Aim. To evaluate the long-term effect (3 years) of continuous subcutaneous insulin infusion (CSII) compared to multiple daily insulin injection (MDI) on renal function, albumin excretion rate(AER), blood pressure and blood glucose variability in type 1 diabetic patients with persistent microalbuminuria.in optimal antihypertensive treatment (ie, with a maximum tolerated dose of ACE-inhibitors).
Methods. In a multicentre prospective study were enrolled 62 type 1 diabetic patients with persistent microalbuminuria: 26 patients treated with CSII and 24 treated with MDI (with glargine as basal insulin), matched for age (CSII 40.3±9.3 yrs., MDI 42.2±11.1 yrs.), diabetes duration (CSII 27±8.2 yrs, MDI 24.3±10.3 yrs.), BMI (CSII 24.4±3.2%, MDI 24.7±4.2%). All patients were treated with the maximal tolerated dose of ACE-inhibitor therapy.Every 6 months, were performed 24-hour blood pressure profiles and interstitial continuous glucose monitoring and were also determined kidney function as glomerural filtration rate (GFR), albumin excretion rate excretion rate of 8-iso-PGF2alfa (as oxidative stress marker).
Results. Albumin excretion rate decreased slightly in MDI group from a median value of 62 μg/min (31-100 IQR) to 59 (33-155 IQR) after three years of follow-up. Albumin excretion rate decreased significantly (p<0.05) from a median value of 72 μg/min (37-154 IQR) to 24 (11-57 IQR) in CSII group. In particular only 3 patients in MDI group regressed to normoalbuminuria at the end of follow-up, whereas 14 patients in CSII group regressed to normoalbuminuria (p<0.001). GFR was similar in both groups at entry into the study. During the study a decline of GFR was greater in patients treated with MDI (-7.9±9.9 ml/min/yr) than those in CSII (-3.08±3.3 ml/min/yr; p < 0.05). A1c levels were similar in MDI and CSII groups at entry into the study (8.4±1.5% vs 8.2 ± 1.0% respectively) and remained unchanged throughout the study (A1c 7.8±1.2 % in MDI group vs 8.0±1.1% in CSII group). Also glycemic variability index remained unchanged throughout the study. Insulin dose, in particular, total rapid insulin dosage was significantly higher in MDI group than boluses in CSII group both at entry (0.36±0.4 vs 0.2±0.07 U//kg/day) and at the end of study (0.28±17 vs 0.19±0.08 U/kg/day)(p<0.01). 24-hour blood pressure was well controlled in both groups and stable throughout the study. At the end of the study the systolic blood pressure (SBP) was CSII group 127±13 mm/Hg and in MDI group 127±10 mmHg; the diastolic blood pressure (DBP) was in CSII group 75±7 in MDI group 74±4 mmHg mmHg.
Conclusion. Insulin treatment with continuous subcutaneous insulin infusion was associated to a reduction in the progression of renal damage despite a similar glycemic control. The higher insulin requirement of MDI group suggests a state of insulin resistance, a possible factor in the progression of renal disease. Glycemic variability (VG) does not seem to play an important role in the results obtained.

Abstract (italiano)

L'effetto a lungo termine dell’infusione subcutanea continua di insulina mediante microinfusore (CSII) comparato alla terapia insulinica multiiniettiva (MDI) sulla funzione renale, sul tasso di escrezione urinaria di albumina e sulla pressione arteriosa in pazienti con diabete di tipo 1 con microalbuminuria persistente
Riassunto
Scopo. Valutare l'effetto a lungo termine (3 anni) dell’infusione subcutanea continua di insulina mediante microinfusore (CSII) rispetto alla terapia insulinica multiiniettiva (MDI) sul tasso di escrezione di albumina, la funzione renale, la pressione sanguigna e la variabilità della glicemia nei pazienti diabetici di tipo 1 con microalbuminuria persistente in trattamento antipertensivo ottimale (cioè con una dose massima tollerata di ACE-inibitori).
Materiali e metodi. Nello studio prospettico multicentrico sono stati arruolati 50 pazienti con diabete tipo1 e microalbuminuria persistente di cui 26 erano trattati con CSII e 24 con MDI (con glargine come insulina basale), comparati per età (CSII 40.3±9.3 anni, MDI 42.2±11.1 anni), durata del diabete (CSII 27±8.2 anni, MDI 24.3±10.3 anni), BMI (CSII 24.4±3.2%, MDI 24.7±4.2%). Tutti erano in terapia con la massima dose tollerata di ACE inibitore. Ogni 6 mesi sono stati eseguiti i profili pressori delle 24 ore e il monitoraggio in continuo del glucosio interstiziale e sono state valutati la funzione renale attraverso la velocità di filtrazione glomerulare (GFR), la velocità di escrezione dell’albumina (AER), la escrezione urinaria di 8-iso-PGF2alfa (come marker di stress ossidativo).
Risultati. Il tasso di escrezione di albumina si è leggermente ridotto nel gruppo MDI da un valore medio di 62 μg/min (31-100 IQR) a 59 μg/min (33-155 IQR), dopo tre anni di follow-up, mentre si è ridotto significativamente (p <0.05) nel gruppo CSII. In particolare a partire da un valore medio di 72 μg/min (37-154 IQR) a 24 μg/min(11-54 IQR). Solo in 3 pazienti nel gruppo MDI c’è stata regressione a normoalbuminuria alla fine del follow-up, mentre nel gruppo CSII in 14 pazienti c’è stata la regressione alla normoalbuminuria (p <0.001). Il GFR era simile in entrambi i gruppi all’inizio dello studio; durante lo studio si è avuta una maggiore riduzione del GFR nei pazienti trattati con MDI (-7.9 ± 9.9 ml/min/anno) rispetto a quelli trattati con CSII (-3.08 ± 3.3 ml/min/anno; p <0.05). I livelli di HbA1c erano simili nei due gruppi all'inizio nello studio (8.4 ± 1.5 % vs 8.2 ±1.0 % rispettivamente) e sono rimasti invariati nel corso dello studio (HbA1c 7.8 ± 1.2 nel gruppo MDI vs 8.0 ± 1.1 % nel gruppo CSII), così come gli indici di variabilità glicemica (VG). Il fabbisogno insulinico ed in particolare le dosi totali dei boli di insulina rapida erano significativamente maggiori nel gruppo MDI rispetto al gruppo CSII sia all’inizio (0.36 ± 0.4 vs 0.2±0.07 U//kg/die) che alla fine dello studio (0.28±17 vs 0.19±0.08 U//kg/die)(p<0.01). La pressione arteriosa delle 24 ore è stata ben controllata in entrambi i gruppi e stabile per tutta la durata dello studio. Alla fine dello studio, la pressione arteriosa sistolica (SBP) era nel gruppo CSII 127±13 mm/Hg, in quello MDI 127±10 mmHg; la pressione arteriosa diastolica (DBP) era nel gruppo CSII 75±7 mmHg, in quello MDI 74±4 mmHg.
Conclusione: il trattamento insulinico mediante microinfusore, a parità di controllo glicemico, è in grado di rallentare la progressione del danno renale nel diabete di tipo 1. Il maggior fabbisogno insulinico dei pazienti in MDI suggerisce una condizione di insulino-resistenza, possibile fattore di progressione della nefropatia. Non sembra invece che la variabilità glicemica (VG) giochi un ruolo importante nei risultati ottenuti.

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Tipo di EPrint:Tesi di dottorato
Relatore:Avogaro, Angelo
Dottorato (corsi e scuole):Ciclo 24 > Scuole 24 > SCIENZE MEDICHE, CLINICHE E SPERIMENTALI > SCIENZE DIABETOLOGICHE
Data di deposito della tesi:28 Gennaio 2014
Anno di Pubblicazione:28 Gennaio 2014
Parole chiave (italiano / inglese):microinfusore, CSII, terapia insulinica multiiniettiva, MDI, microalbuminuria, variabilita'  glicemica, subcutaneous insulin infusion, multiple daily insulin injection, glycemic variability
Settori scientifico-disciplinari MIUR:Area 06 - Scienze mediche > MED/11 Malattie dell'apparato cardiovascolare
Area 06 - Scienze mediche > MED/09 Medicina interna
Area 06 - Scienze mediche > MED/13 Endocrinologia
Struttura di riferimento:Dipartimenti > Dipartimento di Scienze Cardiologiche, Toraciche e Vascolari
Codice ID:6523
Depositato il:31 Ott 2014 13:25
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