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Effect of 1-year oral cholecalciferol on a metabolic profile and blood pressure in poor-controlled type 2 diabetes mellitus: an open-label randomized controlled pilot study

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Abstract

Purpose

Hypovitaminosis D has been associated with many cardio-metabolic disorders, although their pathogenetic link still remains unclear. Our aim was to evaluate whether 1-year vitamin D (D) supplementation could improve glycemic control, lipid profile, systolic (SBP) and diastolic (DBP) blood pressure levels and body composition.

Methods

In an open-label randomized-controlled pilot study, thirty poor-controlled (HbA1c > 59 mmol/mol) type 2 diabetic patients (age 71.5 ± 3.2 years, M/F 21/9, BMI 29.8 ± 3.6 kg/m2) with hypovitaminosis D (25OHD 22.0 ± 11.3 nmol/l) were randomized to cholecalciferol supplementation (500 UI/kg p.o. weekly, + D) or observation (− D) for one year. Changes in parameters of glucose, lipid and blood pressure control at 3, 6, 9 and 12 months vs. baseline were assessed.

Results

One-year D supplementation restored D status and had a beneficial effect on fasting glucose (FG, mean percentage changes ± SD, − 1.8% ± 23.1 vs. + 18.8% ± 30.0), glycosylated haemoglobin (HbA1c, − 13.7% ± 14.5 vs. − 4.2% ± 14.1), SBP (− 13.4% ± 8.5 vs. − 2.4% ± 12.6) and HDL-cholesterol levels (− 2.1% ± 14.0 vs. − 10.9% ± 12.9; p < 0.05 for all comparisons) in + D vs. − D patients, respectively. In the former, a reduction in HBA1c, SBP and DBP levels, BMI, fat mass index (FMI) and ratio (FMR) was observed after 1 year (p < 0.05 for all comparisons vs. baseline). We noticed a relationship between 1-year mean percentage changes of serum 25OHD and SBP levels (R = − 0.36, p < 0.05).

Conclusion

One-year cholecalciferol supplementation, able to restore D status, significantly improves FG, HbA1c, SBP and HDL-cholesterol levels in patients with poor-controlled type 2 diabetes mellitus and D deficiency.

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Acknowledgments

The Authors would like to gratefully thank the dearly deceased Prof. Franco Camanni for planning study design, the radiologic technologists Mr Francesco Moricca and Damiano Allegro for their skillfulness in performing DXA test and Dr Giulia Castagno for English language review.

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Authors and Affiliations

  1. Department of General and Specialty Medicine, Division of Endocrinology, Diabetology and Metabolic Diseases, Molinette Hospital, University of Turin - Cso Dogliotti, 14-10126, Turin, Italy

    M. Barale, R. Rossetto Giaccherino, E. Ghigo & M. Procopio

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  1. M. Barale
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  2. R. Rossetto Giaccherino
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  3. E. Ghigo
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  4. M. Procopio
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All authors contributed equally to this work; all authors contributed to the content, reviewed and revised drafts of the work, and approved the final version.

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Correspondence to M. Barale.

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The authors declare that they have no conflict of interest.

Ethics approval and research involving human participants and/or animals

All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committee (name of the ethics committee: Comitato Etico Interaziendale—AOU S. Giovanni Battista di Torino / AO CTO / Maria Adelaide di Torino; Project identification code: 0050172; date of approval: 29/04/2013) and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards.

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Written informed consent was obtained individually from all participants included in the study.

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Written informed consent for publication was obtained from all patients included in the study.

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The datasets generated during the current study are available from the corresponding author on reasonable request.

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Barale, M., Rossetto Giaccherino, R., Ghigo, E. et al. Effect of 1-year oral cholecalciferol on a metabolic profile and blood pressure in poor-controlled type 2 diabetes mellitus: an open-label randomized controlled pilot study. J Endocrinol Invest 44, 791–802 (2021). https://doi.org/10.1007/s40618-020-01373-8

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