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Relationship between serum osteocalcin/undercarboxylated osteocalcin and type 2 diabetes: a systematic review/meta-analysis study protocol.

ABSTRACT: INTRODUCTION:The global burden of type 2 diabetes (T2DM) is steadily increasing. Experimental studies have demonstrated that a novel hormone secreted by bone cells, osteocalcin (OC), can stimulate beta-cell proliferation and improve insulin sensitivity in mice. Observational studies in humans have investigated the relationship between OC and metabolic parameters, and T2DM. Importantly, few studies have reported on the undercarboxylated form of OC (ucOC), which is the putative active form of OC suggested to affect glucose metabolism. OBJECTIVES:We will conduct a systematic review and meta-analysis to: (1) compare the levels of serum OC and ucOC between T2DM and normal glucose-tolerant controls (NGC); (2) investigate the risk ratios between serum OC and ucOC, and T2DM; (3) determine the correlation coefficient between OC and ucOC and fasting insulin levels, homeostatic model assessment-insulin resistance, haemoglobin A1c and fasting glucose levels and (4) explore potential sources of between-study heterogeneity. The secondary objective is to compare the serum OC and ucOC between pre-diabetes (PD) and NGC and between T2DM and PD. HODS AND ANALYSIS:This study will report items in line with the guidelines outlined in preferred reporting items for systematic reviews and meta-analysis of observational studies in epidemiology. We will include observational studies (cohort, case-control and cross-sectional studies) and intervention studies with baseline data. Three databases (MEDLINE, EMBASE and SCOPUS) will be searched from inception until July 2018 without language restrictions. Two reviewers will independently screen the titles and abstracts and conduct a full-text assessment to identify eligible studies. Discrepancies will be resolved by consensus with a third reviewer. The risk of bias assessment will be conducted by two reviewers independently based on the Newcastle-Ottawa Scale. Potential sources of between-study heterogeneity will be tested using meta-regression/subgroup analyses. Contour-enhanced funnel plots and Egger's test will be used to identify potential publication bias. ETHICS AND DISSEMINATION:Formal ethical approval is not required. We will disseminate the results to a peer-reviewed publication and conference presentation. PROSPERO REGISTRATION NUMBER:CRD42017073127.

SUBMITTER: Liu Y

PROVIDER: S-EPMC6429918 | biostudies-literature | 2019 Mar

REPOSITORIES: biostudies-literature

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Project description: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.

Project description:Background: This systematic review analyzed the relationship between alexithymia, considered as the inability to recognize and express thoughts and emotions, and type 2 diabetes mellitus (T2DM), one of the most common chronic illness, characterized by a metabolic disorder burdened by high morbidity and mortality worldwide due to its outcomes. Methods: PRISMA guidelines were followed throughout this systematic review of the recent literature indexed in the databases PubMed, PsycInfo, Scopus, and Web of Science. Search terms for eligible studies were: "Type 2 diabetes" OR "T2DM" AND "Toronto Alexithymia Scale" OR "TAS-20"[All Fields]. Results: The initial search identified 61 indexed scientific publications. After screening we found that seven publications met the established scientific inclusion and exclusion criteria. It emerged that alexithymic patients ranged from 25 to 50% across the examined publications and it appeared that patients with T2DM generally reflected greater values of alexithymia, revealing particular differences among TAS domains. Moreover, emlpoyed participants were alexithymic to a greater extent compared to non-working participants (77.8 vs. 35.4%) and alexithymia was 2.63 times more severe among working participants when examining predictors of alexithymia. When evaluating the correlations between alexithymia and HbA1c or fasting blood glucose levels we found strong associations equal to 0.75 and 0.77 for TAS-20 total scores, respectively. While alexithymic participants showed significantly higher levels of HbA1c and blood glucose when compared to the non-alexithymic participants. Conclusions: The results of this systematic review of the current literature highlight the need of alexithymia evaluation in patients with T2DM. The high prevalence in T2DM and strong associations with poorly regulated diabetes and psychological distress, indicate a significant relationship between poor glycemic control and psychological distress, such as anxiety and depression, and quality of life. Further studies are needed focusing on age and gender differences in order to be able to improve clinical psychological care and prevention.

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Relationship between serum osteocalcin/undercarboxylated osteocalcin and type 2 diabetes: a systematic review/meta-analysis study protocol.

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