Effect of supplementation with vitamins D3 and K2 on undercarboxylated osteocalcin and insulin serum levels in patients

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abetology & Metabolic Syndrome Open Access

RESEARCH

Effect of supplementation with vitamins D3 and K2 on undercarboxylated osteocalcin and insulin serum levels in patients with type 2 diabetes mellitus: a randomized, double‑blind, clinical trial J. I. Aguayo‑Ruiz1, T. A. García‑Cobián3, S. Pascoe‑González3, S. Sánchez‑Enríquez4, I. M. Llamas‑Covarrubias2, T. García‑Iglesias3, A. López‑Quintero2, M. A. Llamas‑Covarrubias2, J. Trujillo‑Quiroz3 and E. A. Rivera‑Leon2*

Abstract  Background:  Patients with type 2 diabetes mellitus (T2DM) are characterized by chronic hyperglycemia as a con‑ sequence of decreased insulin sensitivity, which contributes to bone demineralization and could also be related to changes in serum levels of osteocalcin and insulin, particularly when coupled with a deficiency in the daily consump‑ tion of vitamins D3 and K2. The objective of this study was to evaluate the effect of vitamin D3 and vitamin K2 supple‑ ments alone or in combination on osteocalcin levels and metabolic parameters in patients with T2DM. Methods:  A double-blind, randomized clinical trial was carried out in 40 patients aged between 30 and 70 years old for 3 months. Clinical and laboratory assessment was carried out at the beginning and at the end of the treatment. The patients were divided into three groups: (a) 1000 IU vitamin D3 + a calcinated magnesium placebo (n = 16), (b) 100 µg of Vitamin K2 + a calcinated magnesium placebo (n = 12), and (c) 1000 IU vitamin D3 + 100 µg vitamin K2 (n = 12). Results:  After treatment in the total studied population, a significant decrease in glycemia (p = 0.001), HOMA-IR (Homeostatic model assessment-insulin resistance) (p = 0.040), percentage of pancreatic beta cells (p