A randomized trial of nicotinamide and vitamin E in children with recent onset type 1 diabetes (IMDIAB IX)

A. Crinò, R. Schiaffini, Silvia Manfrini, C. Mesturino, Natalia Visalli, G. Beretta Anguissola, C. Suraci, D. Pitocco, Sabrina Spera, S. Corbi, M. C. Matteoli, I. P. Patera, Maria L. Manca Bitti, C. Bizzarri, Paulo Pozzilli, Elvira Fioriti, Giusy Coppolino, Luciana Valente, Chiara Guglielmi, Flavia ContanzaAnna Lisa Montemari, Manon Khazrai Merola, Cesarea Leomanni, Maria C. Matteoli, Marco Cappa, Antonio Crinò, Marco Cervoni, Anna Cantagallo, Giancarlo De Mattia, Maria R. Cassone Faldetta, Giovanni Ghirlanda

Research output: Contribution to journalArticle

Abstract

Objective: Various adjuvant therapies have been introduced along with intensive insulin therapy in patients with recent onset type 1 diabetes. Nicotinamide (NA), administered at diagnosis of the disease, can have beneficial effects on the clinical remission rate, improve metabolic control and preserve or slightly increase beta-cell function, probably by reducing toxicity due to free oxygen radicals. Vitamin E, a known antioxidant, inhibits lipid peroxidation; this can lead to protection of islet beta cells from the combined effects of interleukin 1, tumor necrosis factor and gamma interferon. The aim of the present study was to investigate whether the addition of vitamin E to NA could improve metabolic control and the residual beta-cell function, as measured by C-peptide secretion, in children and adolescents with recent onset type 1 diabetes; patients were followed-up for 2 years after diagnosis. Patients and study design: Recent onset type 1 diabetes patients (n = 64, mean age 8.8 years) were recruited by participating centres of the IMDIAB group. Thirty-two patients were randomized to NA (25 mg/kg body weight) plus vitamin E (15 mg/kg body weight); 32 patients acted as controls and received NA only at the same dose as above. Intensive insulin therapy was applied to both treatment groups. Results: There were three drop outs during the 2-year follow-up period. Overall, patients assigned to the NA + vitamin E group or the NA group did not significantly differ in terms of glycated hemoglobin (HbA1c) levels, insulin requirement or baseline C-peptide secretion. Patients diagnosed at an age of less than 9 years showed significantly reduced C-peptide levels compared with those aged over 9 years at diagnosis and at the 2-year follow-up but there were no differences between the NA and NA + vitamin E treated groups. However at 6 months, patients over 9 years of age treated with NA + vitamin E showed significantly higher C-peptide compared with the NA group (P <0.003). In both age groups and in the different treatment groups, C-peptide levels found at diagnosis were preserved 2 years later. Conclusions: The use of NA alone, or in combination with vitamin E, along with intensive insulin therapy is able to preserve baseline C-peptide secretion for up to 2 years after diagnosis. This finding is of particular interest for pre-pubertal children with type 1 diabetes and has never been reported before.

Original languageEnglish
Pages (from-to)719-724
Number of pages6
JournalEuropean Journal of Endocrinology
Volume150
Issue number5
DOIs
Publication statusPublished - May 2004

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Niacinamide
Vitamin E
Type 1 Diabetes Mellitus
C-Peptide
Insulin
Therapeutics
Body Weight
Glycosylated Hemoglobin A
Interleukin-1
Islets of Langerhans
Lipid Peroxidation
Interferon-gamma
Free Radicals
Reactive Oxygen Species
Age Groups
Tumor Necrosis Factor-alpha
Antioxidants

ASJC Scopus subject areas

  • Endocrinology

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A randomized trial of nicotinamide and vitamin E in children with recent onset type 1 diabetes (IMDIAB IX). / Crinò, A.; Schiaffini, R.; Manfrini, Silvia; Mesturino, C.; Visalli, Natalia; Anguissola, G. Beretta; Suraci, C.; Pitocco, D.; Spera, Sabrina; Corbi, S.; Matteoli, M. C.; Patera, I. P.; Manca Bitti, Maria L.; Bizzarri, C.; Pozzilli, Paulo; Fioriti, Elvira; Coppolino, Giusy; Valente, Luciana; Guglielmi, Chiara; Contanza, Flavia; Montemari, Anna Lisa; Khazrai Merola, Manon; Leomanni, Cesarea; Matteoli, Maria C.; Cappa, Marco; Crinò, Antonio; Cervoni, Marco; Cantagallo, Anna; De Mattia, Giancarlo; Cassone Faldetta, Maria R.; Ghirlanda, Giovanni.

In: European Journal of Endocrinology, Vol. 150, No. 5, 05.2004, p. 719-724.

Research output: Contribution to journalArticle

Crinò, A, Schiaffini, R, Manfrini, S, Mesturino, C, Visalli, N, Anguissola, GB, Suraci, C, Pitocco, D, Spera, S, Corbi, S, Matteoli, MC, Patera, IP, Manca Bitti, ML, Bizzarri, C, Pozzilli, P, Fioriti, E, Coppolino, G, Valente, L, Guglielmi, C, Contanza, F, Montemari, AL, Khazrai Merola, M, Leomanni, C, Matteoli, MC, Cappa, M, Crinò, A, Cervoni, M, Cantagallo, A, De Mattia, G, Cassone Faldetta, MR & Ghirlanda, G 2004, 'A randomized trial of nicotinamide and vitamin E in children with recent onset type 1 diabetes (IMDIAB IX)', European Journal of Endocrinology, vol. 150, no. 5, pp. 719-724. https://doi.org/10.1530/eje.0.1500719
Crinò, A. ; Schiaffini, R. ; Manfrini, Silvia ; Mesturino, C. ; Visalli, Natalia ; Anguissola, G. Beretta ; Suraci, C. ; Pitocco, D. ; Spera, Sabrina ; Corbi, S. ; Matteoli, M. C. ; Patera, I. P. ; Manca Bitti, Maria L. ; Bizzarri, C. ; Pozzilli, Paulo ; Fioriti, Elvira ; Coppolino, Giusy ; Valente, Luciana ; Guglielmi, Chiara ; Contanza, Flavia ; Montemari, Anna Lisa ; Khazrai Merola, Manon ; Leomanni, Cesarea ; Matteoli, Maria C. ; Cappa, Marco ; Crinò, Antonio ; Cervoni, Marco ; Cantagallo, Anna ; De Mattia, Giancarlo ; Cassone Faldetta, Maria R. ; Ghirlanda, Giovanni. / A randomized trial of nicotinamide and vitamin E in children with recent onset type 1 diabetes (IMDIAB IX). In: European Journal of Endocrinology. 2004 ; Vol. 150, No. 5. pp. 719-724.
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abstract = "Objective: Various adjuvant therapies have been introduced along with intensive insulin therapy in patients with recent onset type 1 diabetes. Nicotinamide (NA), administered at diagnosis of the disease, can have beneficial effects on the clinical remission rate, improve metabolic control and preserve or slightly increase beta-cell function, probably by reducing toxicity due to free oxygen radicals. Vitamin E, a known antioxidant, inhibits lipid peroxidation; this can lead to protection of islet beta cells from the combined effects of interleukin 1, tumor necrosis factor and gamma interferon. The aim of the present study was to investigate whether the addition of vitamin E to NA could improve metabolic control and the residual beta-cell function, as measured by C-peptide secretion, in children and adolescents with recent onset type 1 diabetes; patients were followed-up for 2 years after diagnosis. Patients and study design: Recent onset type 1 diabetes patients (n = 64, mean age 8.8 years) were recruited by participating centres of the IMDIAB group. Thirty-two patients were randomized to NA (25 mg/kg body weight) plus vitamin E (15 mg/kg body weight); 32 patients acted as controls and received NA only at the same dose as above. Intensive insulin therapy was applied to both treatment groups. Results: There were three drop outs during the 2-year follow-up period. Overall, patients assigned to the NA + vitamin E group or the NA group did not significantly differ in terms of glycated hemoglobin (HbA1c) levels, insulin requirement or baseline C-peptide secretion. Patients diagnosed at an age of less than 9 years showed significantly reduced C-peptide levels compared with those aged over 9 years at diagnosis and at the 2-year follow-up but there were no differences between the NA and NA + vitamin E treated groups. However at 6 months, patients over 9 years of age treated with NA + vitamin E showed significantly higher C-peptide compared with the NA group (P <0.003). In both age groups and in the different treatment groups, C-peptide levels found at diagnosis were preserved 2 years later. Conclusions: The use of NA alone, or in combination with vitamin E, along with intensive insulin therapy is able to preserve baseline C-peptide secretion for up to 2 years after diagnosis. This finding is of particular interest for pre-pubertal children with type 1 diabetes and has never been reported before.",
author = "A. Crin{\`o} and R. Schiaffini and Silvia Manfrini and C. Mesturino and Natalia Visalli and Anguissola, {G. Beretta} and C. Suraci and D. Pitocco and Sabrina Spera and S. Corbi and Matteoli, {M. C.} and Patera, {I. P.} and {Manca Bitti}, {Maria L.} and C. Bizzarri and Paulo Pozzilli and Elvira Fioriti and Giusy Coppolino and Luciana Valente and Chiara Guglielmi and Flavia Contanza and Montemari, {Anna Lisa} and {Khazrai Merola}, Manon and Cesarea Leomanni and Matteoli, {Maria C.} and Marco Cappa and Antonio Crin{\`o} and Marco Cervoni and Anna Cantagallo and {De Mattia}, Giancarlo and {Cassone Faldetta}, {Maria R.} and Giovanni Ghirlanda",
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TY - JOUR

T1 - A randomized trial of nicotinamide and vitamin E in children with recent onset type 1 diabetes (IMDIAB IX)

AU - Crinò, A.

AU - Schiaffini, R.

AU - Manfrini, Silvia

AU - Mesturino, C.

AU - Visalli, Natalia

AU - Anguissola, G. Beretta

AU - Suraci, C.

AU - Pitocco, D.

AU - Spera, Sabrina

AU - Corbi, S.

AU - Matteoli, M. C.

AU - Patera, I. P.

AU - Manca Bitti, Maria L.

AU - Bizzarri, C.

AU - Pozzilli, Paulo

AU - Fioriti, Elvira

AU - Coppolino, Giusy

AU - Valente, Luciana

AU - Guglielmi, Chiara

AU - Contanza, Flavia

AU - Montemari, Anna Lisa

AU - Khazrai Merola, Manon

AU - Leomanni, Cesarea

AU - Matteoli, Maria C.

AU - Cappa, Marco

AU - Crinò, Antonio

AU - Cervoni, Marco

AU - Cantagallo, Anna

AU - De Mattia, Giancarlo

AU - Cassone Faldetta, Maria R.

AU - Ghirlanda, Giovanni

PY - 2004/5

Y1 - 2004/5

N2 - Objective: Various adjuvant therapies have been introduced along with intensive insulin therapy in patients with recent onset type 1 diabetes. Nicotinamide (NA), administered at diagnosis of the disease, can have beneficial effects on the clinical remission rate, improve metabolic control and preserve or slightly increase beta-cell function, probably by reducing toxicity due to free oxygen radicals. Vitamin E, a known antioxidant, inhibits lipid peroxidation; this can lead to protection of islet beta cells from the combined effects of interleukin 1, tumor necrosis factor and gamma interferon. The aim of the present study was to investigate whether the addition of vitamin E to NA could improve metabolic control and the residual beta-cell function, as measured by C-peptide secretion, in children and adolescents with recent onset type 1 diabetes; patients were followed-up for 2 years after diagnosis. Patients and study design: Recent onset type 1 diabetes patients (n = 64, mean age 8.8 years) were recruited by participating centres of the IMDIAB group. Thirty-two patients were randomized to NA (25 mg/kg body weight) plus vitamin E (15 mg/kg body weight); 32 patients acted as controls and received NA only at the same dose as above. Intensive insulin therapy was applied to both treatment groups. Results: There were three drop outs during the 2-year follow-up period. Overall, patients assigned to the NA + vitamin E group or the NA group did not significantly differ in terms of glycated hemoglobin (HbA1c) levels, insulin requirement or baseline C-peptide secretion. Patients diagnosed at an age of less than 9 years showed significantly reduced C-peptide levels compared with those aged over 9 years at diagnosis and at the 2-year follow-up but there were no differences between the NA and NA + vitamin E treated groups. However at 6 months, patients over 9 years of age treated with NA + vitamin E showed significantly higher C-peptide compared with the NA group (P <0.003). In both age groups and in the different treatment groups, C-peptide levels found at diagnosis were preserved 2 years later. Conclusions: The use of NA alone, or in combination with vitamin E, along with intensive insulin therapy is able to preserve baseline C-peptide secretion for up to 2 years after diagnosis. This finding is of particular interest for pre-pubertal children with type 1 diabetes and has never been reported before.

AB - Objective: Various adjuvant therapies have been introduced along with intensive insulin therapy in patients with recent onset type 1 diabetes. Nicotinamide (NA), administered at diagnosis of the disease, can have beneficial effects on the clinical remission rate, improve metabolic control and preserve or slightly increase beta-cell function, probably by reducing toxicity due to free oxygen radicals. Vitamin E, a known antioxidant, inhibits lipid peroxidation; this can lead to protection of islet beta cells from the combined effects of interleukin 1, tumor necrosis factor and gamma interferon. The aim of the present study was to investigate whether the addition of vitamin E to NA could improve metabolic control and the residual beta-cell function, as measured by C-peptide secretion, in children and adolescents with recent onset type 1 diabetes; patients were followed-up for 2 years after diagnosis. Patients and study design: Recent onset type 1 diabetes patients (n = 64, mean age 8.8 years) were recruited by participating centres of the IMDIAB group. Thirty-two patients were randomized to NA (25 mg/kg body weight) plus vitamin E (15 mg/kg body weight); 32 patients acted as controls and received NA only at the same dose as above. Intensive insulin therapy was applied to both treatment groups. Results: There were three drop outs during the 2-year follow-up period. Overall, patients assigned to the NA + vitamin E group or the NA group did not significantly differ in terms of glycated hemoglobin (HbA1c) levels, insulin requirement or baseline C-peptide secretion. Patients diagnosed at an age of less than 9 years showed significantly reduced C-peptide levels compared with those aged over 9 years at diagnosis and at the 2-year follow-up but there were no differences between the NA and NA + vitamin E treated groups. However at 6 months, patients over 9 years of age treated with NA + vitamin E showed significantly higher C-peptide compared with the NA group (P <0.003). In both age groups and in the different treatment groups, C-peptide levels found at diagnosis were preserved 2 years later. Conclusions: The use of NA alone, or in combination with vitamin E, along with intensive insulin therapy is able to preserve baseline C-peptide secretion for up to 2 years after diagnosis. This finding is of particular interest for pre-pubertal children with type 1 diabetes and has never been reported before.

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