Abstract
BackgroundPatients with type 2 diabetes mellitus (T2DM) are characterized by chronic hyperglycemia as a consequence 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 consumption of vitamins D3 and K2. The objective of this study was to evaluate the effect of vitamin D3 and vitamin K2 supplements alone or in combination on osteocalcin levels and metabolic parameters in patients with T2DM.MethodsA 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).ResultsAfter 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 < 0.001), uOC/cOC index and diastolic blood pressure (p = 0.030) were observed; in vitamin D3 group, differences in serum undercarboxylated osteocalcin (p = 0.026), undercarboxylated to carboxylated osteocalcin index (uOC/cOC) (p = 0.039) glucose (p < 0.001) and % of functional pancreatic beta cells (p < 0.001) were demonstrated. In vitamin K2 group a significant decrease in glycemia (p = 0.002), HOMA-IR (p = 0.041), percentage of pancreatic beta cells (p = 0.002), and in cOC (p = 0.041) were observed, conversely cOC concentration was found high. Finally, in the vitamins D3 + K2 a significant decrease in glycemia (p = 0.002), percentage of pancreatic beta cells (p = 0.004), and in the uOC/cOC index (p = 0.023) were observed.ConclusionIndividual or combined supplementation with vitamins D3 and K2 significantly decreases the glucose levels and % of functional pancreatic beta cells, while D3 and D3 + K2 treatments also induced a reduction in the uOC/cOC index. Only in the group with vitamin D3 supplementation, it was observed a reduction in undercarboxylated osteocalcin while vitamin K2 increased the carboxylated osteocalcin levels.Trial registration NCT04041492
Highlights
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 be related to changes in serum levels of osteocalcin and insulin, when coupled with a deficiency in the daily consump‐ tion of vitamins D3 and K2
Total population was 40 patients distributed into 3 different groups: supplementation with Vitamin D3 (n = 16), supplementation with Vitamin K2 (n = 12) and supplementation with Vitamin D3 + K2 (n = 12)
In the case of vitamin K2, there were not found differences in the before mentioned variables (Table 4), and the same occurred with the simultaneous administration of vitamin D3 + K2 (Table 5)
Summary
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 be related to changes in serum levels of osteocalcin and insulin, 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. Diabetes mellitus (DM) is a group of metabolic diseases characterized by hyperglycemia as a result of defects in the secretion or action of insulin or both. Chronic hyperglycemia in diabetes has been associated in the long term with damage, dysfunction or failure of certain organs, the eyes, kidneys, nerves, heart, and blood vessels [1]. Hyperglycemia affects the adequate function of osteoblasts which is mediated by their sensitivity to an acidic environment produced by lactate, causing alterations in the formation of collagen fibers, in secondary mineralization and in the formation of the protein-rich extracellular matrix [8]
Sign-in/Register to view highlights & summary Sign-in/Register to access full text options 
Talk to us
Join us for a 30 min session where you can share your feedback and ask us any queries you have
Schedule a callDisclaimer: All third-party content on this website/platform is and will remain the property of their respective owners and is provided on "as is" basis without any warranties, express or implied. Use of third-party content does not indicate any affiliation, sponsorship with or endorsement by them. Any references to third-party content is to identify the corresponding services and shall be considered fair use under The CopyrightLaw.
