PMID- 32831908 OWN - NLM STAT- PubMed-not-MEDLINE LR - 20231112 IS - 1758-5996 (Print) IS - 1758-5996 (Electronic) IS - 1758-5996 (Linking) VI - 12 DP - 2020 TI - 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. PG - 73 LID - 10.1186/s13098-020-00580-w [doi] LID - 73 AB - BACKGROUND: Patients 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. 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 microg of Vitamin K2 + a calcinated magnesium placebo (n = 12), and (c) 1000 IU vitamin D3 + 100 microg 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 < 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. CONCLUSION: Individual 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. CI - (c) The Author(s) 2020. FAU - Aguayo-Ruiz, J I AU - Aguayo-Ruiz JI AD - Pharmacology, Health Sciences University Center (CUCS), Universidad de Guadalajara (UdeG), 44350 Guadalajara, Jalisco Mexico. GRID: grid.412890.6. ISNI: 0000 0001 2158 0196 FAU - Garcia-Cobian, T A AU - Garcia-Cobian TA AD - Department of Physiology, Health Sciences University Center (CUCS), Universidad de Guadalajara (UdeG), 44350 Guadalajara, Jalisco Mexico. GRID: grid.412890.6. ISNI: 0000 0001 2158 0196 FAU - Pascoe-Gonzalez, S AU - Pascoe-Gonzalez S AD - Department of Physiology, Health Sciences University Center (CUCS), Universidad de Guadalajara (UdeG), 44350 Guadalajara, Jalisco Mexico. GRID: grid.412890.6. ISNI: 0000 0001 2158 0196 FAU - Sanchez-Enriquez, S AU - Sanchez-Enriquez S AD - Department of Clinics, Altos University Center (CuAltos), Universidad de Guadalajara (UdeG), 47620 Tepatitlan de Morelos, Jalisco Mexico. GRID: grid.412890.6. ISNI: 0000 0001 2158 0196 FAU - Llamas-Covarrubias, I M AU - Llamas-Covarrubias IM AD - Department of Molecular Biology and Genomics, Health Sciences University Center (CUCS), Universidad de Guadalajara (UdeG), 44350 Guadalajara, Jalisco Mexico. GRID: grid.412890.6. ISNI: 0000 0001 2158 0196 FAU - Garcia-Iglesias, T AU - Garcia-Iglesias T AD - Department of Physiology, Health Sciences University Center (CUCS), Universidad de Guadalajara (UdeG), 44350 Guadalajara, Jalisco Mexico. GRID: grid.412890.6. ISNI: 0000 0001 2158 0196 FAU - Lopez-Quintero, A AU - Lopez-Quintero A AD - Department of Molecular Biology and Genomics, Health Sciences University Center (CUCS), Universidad de Guadalajara (UdeG), 44350 Guadalajara, Jalisco Mexico. GRID: grid.412890.6. ISNI: 0000 0001 2158 0196 FAU - Llamas-Covarrubias, M A AU - Llamas-Covarrubias MA AD - Department of Molecular Biology and Genomics, Health Sciences University Center (CUCS), Universidad de Guadalajara (UdeG), 44350 Guadalajara, Jalisco Mexico. GRID: grid.412890.6. ISNI: 0000 0001 2158 0196 FAU - Trujillo-Quiroz, J AU - Trujillo-Quiroz J AD - Department of Physiology, Health Sciences University Center (CUCS), Universidad de Guadalajara (UdeG), 44350 Guadalajara, Jalisco Mexico. GRID: grid.412890.6. ISNI: 0000 0001 2158 0196 FAU - Rivera-Leon, E A AU - Rivera-Leon EA AD - Department of Molecular Biology and Genomics, Health Sciences University Center (CUCS), Universidad de Guadalajara (UdeG), 44350 Guadalajara, Jalisco Mexico. GRID: grid.412890.6. ISNI: 0000 0001 2158 0196 LA - eng SI - ClinicalTrials.gov/NCT04041492 PT - Journal Article DEP - 20200818 PL - England TA - Diabetol Metab Syndr JT - Diabetology & metabolic syndrome JID - 101488958 PMC - PMC7436967 OTO - NOTNLM OT - Insulin OT - Osteocalcin OT - T2DM OT - Vitamin D OT - Vitamin K COIS- Competing interestsThere are no conflicts of interest between the authors. EDAT- 2020/08/25 06:00 MHDA- 2020/08/25 06:01 PMCR- 2020/08/18 CRDT- 2020/08/25 06:00 PHST- 2020/05/25 00:00 [received] PHST- 2020/08/13 00:00 [accepted] PHST- 2020/08/25 06:00 [entrez] PHST- 2020/08/25 06:00 [pubmed] PHST- 2020/08/25 06:01 [medline] PHST- 2020/08/18 00:00 [pmc-release] AID - 580 [pii] AID - 10.1186/s13098-020-00580-w [doi] PST - epublish SO - Diabetol Metab Syndr. 2020 Aug 18;12:73. doi: 10.1186/s13098-020-00580-w. eCollection 2020.