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A pilot study of d-chiro-inositol plus folic acid in overweight patients with type 1 diabetes

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Abstract

Aims

To improve insulin sensitivity, insulin-sensitizing drugs such as metformin are commonly used in overweight and obese T1D patients. Similarly to metformin, d-chiro-inositol (DCI), as putative mediator of intracellular insulin action, can act as insulin sensitizer. The aim of this pilot study was to evaluate the hypothesis that DCI plus folic acid may improve glucose control reducing insulin resistance in overweight or obese T1D patients.

Methods

A 24-week randomized control trial was carried out in 26 overweight or obese T1D patients, undergoing intensive insulin therapy. Patients were randomized to 1 g DCI plus 400 mcg folic acid once daily (treated group) or to 400 mcg folic acid only once daily (control group). The primary end point was to evaluate the efficacy of DCI on metabolic control as assessed by HbA1c. As secondary endpoints, BMI and insulin requirement (IR) were evaluated. Paired t test (two tailed) and analysis of variance were used to evaluate differences in HbA1c, BMI and IR at different time points.

Results

A significant reduction in HbA1c levels in treated group versus control group (7.5% ± 0.9 vs. 7.9% ± 1.7, respectively, p < 0.05) was observed. However, no significant reduction in BMI and IR was observed [(BMI 25.7 ± 2.8 vs. 26.7 ± 1.0, respectively, p NS); (IR 0.52 ± 0.26 vs. 0.52 ± 0.19, respectively, p NS)].

Conclusions

This trial demonstrated for the first time that DCI plus folic acid oral supplementation can improve metabolic control in overweight T1D patients.

ClinicalTrial.Gov ID

NCT02730949.

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Abbreviations

DCI:

d-chiro-Inositol

T1D:

Type 1 diabetes

IR:

Insulin requirement

MDI:

Multiple daily injection

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Funding

This study was supported by an educational grant to University Campus Bio-Medico by LJ Pharma. LJ Pharma also provides the caps of 1 g of DCI plus 200 mcg folic acid (CHIROFOL 500 ® LJ Pharma) and the caps of 200 mcg folic acid (FOLICO ® LJ Pharma). The research sponsor played no role in the design or conduct of the study, collection, management, analysis or interpretation of the data.

Author contributions

A.R.M. designed the study, performed statistical analysis and wrote the manuscript. M.M., R.D.T., S.K., D.M. C.G., A.L.P researched data, E.F. contributed to the discussion, S.M. and P.P. reviewed/edited the manuscript. A.R.M. is the guarantor of this work and, as such, had full access to all the data in the study and takes responsibility for the integrity of the data and the accuracy of the data analysis.

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Authors and Affiliations

  1. Department of Endocrinology and Diabetes, University Campus Bio-Medico, Via Alvaro del Portillo 21, 00128, Rome, Italy

    Anna Rita Maurizi, Marika Menduni, Rossella Del Toro, Shadi Kyanvash, Daria Maggi, Chiara Guglielmi, Angelo Lauria Pantano, Giuseppe Defeudis, Elvira Fioriti, Silvia Manfrini & Paolo Pozzilli

  2. Centre of Diabetes, Bart’s and The London School of Medicine and Dentistry, Queen Mary’s University of London, London, UK

    Paolo Pozzilli

Authors
  1. Anna Rita Maurizi
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  2. Marika Menduni
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  3. Rossella Del Toro
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  4. Shadi Kyanvash
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  5. Daria Maggi
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  6. Chiara Guglielmi
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  7. Angelo Lauria Pantano
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  8. Giuseppe Defeudis
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  9. Elvira Fioriti
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  10. Silvia Manfrini
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  11. Paolo Pozzilli
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Corresponding author

Correspondence to Anna Rita Maurizi.

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Conflict of interest

None.

Human and animal rights

All procedures followed were in accordance with the ethical standards of the responsible committee on human experimentation (institutional and national) and with the Helsinki Declaration of 1975, as revised in 2008.

Informed consent

Informed consent was obtained from all patients for being included in the study.

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Managed by Antonio Secchi.

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Cite this article

Maurizi, A.R., Menduni, M., Del Toro, R. et al. A pilot study of d-chiro-inositol plus folic acid in overweight patients with type 1 diabetes. Acta Diabetol 54, 361–365 (2017). https://doi.org/10.1007/s00592-016-0954-x

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  • DOI: https://doi.org/10.1007/s00592-016-0954-x

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