Effects of synbiotic supplementation on gut microbiome, serum level of TNF-α, and expression of microRNA-126 and microRNA-146a in patients with type 2 diabetes mellitus: study protocol for a double-blind controlled randomized clinical trial.

BACKGROUND: The dramatic increase in the prevalence of type 2 diabetes mellitus (T2DM) is a global major challenge to health. Circulating microRNAs have been suggested as promising biomarkers for different disorders such as diabetes. Imbalances in the gut microbiome have been revealed to contribute to the progression of multiple diseases including T2DM. Recently, the consumption of probiotics and synbiotics in the treatment of various diseases has shown a substantial growth. The anti-diabetes and anti-inflammatory effects of synbiotics have been indicated, which may be due to their beneficial effects on the gut microbiome. However, further research is needed to assess the effects of synbiotics on the microbiota and their impacts on expression of microRNAs relating to T2DM. Thus, we will aim to assess the effects of synbiotics on microbiota, serum level of tumor necrosis factor-α (TNF-α), and expression of microRNA-126 and microRNA-146a in patients with T2DM. METHODS: Seventy-two patients with T2DM will be recruited in this double-blind randomized parallel placebo-controlled clinical trial. After block matching based on age and sex, participants will be randomly assigned to receive 1000 mg/day synbiotic (Familact) or placebo for 12 weeks. The microRNA-126 and microRNA-146a expression levels will be measured by real-time polymerase chain reaction and serum TNF-α level will be assessed by enzyme-linked immunosorbent assay kit at the beginning and at the end of the study. Determination of the gut microbiota will be done by quantitative polymerase chain reaction methods at baseline and at the end of the trial. Biochemical assessments (glycemic and lipid profiles) will also be conducted at onset and end of the study. DISCUSSION: This is the first randomized controlled trial that will determine the effect of synbiotic supplementation on the gut microbiota and its probable impacts on serum levels of TNF-α and expression of related microRNAs in patients with T2DM. TRIAL REGISTRATION: Iranian Registry of Clinical Trials: IRCT20180624040228N2. Registered on 27 March 2019. http://www.irct.ir/trial/38371.

The efficacy and safety of a high dose of vitamin d in mothers with gestational diabetes mellitus: a randomized controlled clinical trial.

BACKGROUND: During pregnancy and lactation outstanding changes occur in mother's vitamin D metabolism. This study was carried out to evaluate the efficacy of 300,000 IU vitamin D given intramuscularly on body status in new cases of gestational diabetes mellitus (GDM). METHODS: This is a randomized clinical trial with the follow-up period of 3 months. Totally 45 participants were randomly divided into intervention group (IG) and control group (CG). The IG received an IM injection of 300,000 IU of vitamin D, whereas CG did not. The glycosylated hemoglobin A1C (HBA1C), serum 25-OH-D, parathyroid hormone (PTH), serum calcium and phosphorus were measured. RESULTS: Forty five patients including 24 with the mean age of 30.7±6.2 years in the IG and 21 with the mean age of 29.5±4.0 years in the CG participated in the study. The median concentration of serum 25(OH)D3 in the IG was to 62.10 nmol/l after the intervention, showing an increase of around 158%, compared to before intervention (24.25 nmol/l) whereas the CG showed a decrease of around 4.5%. Of the patients, 79.2% of IG and 81.9% of CG suffered to some degree from vitamin D deficiency. These figures were 4.2% and 71.4% for the IG and CG, respectively after the intervention.For the IG, the PTH was significantly lower and Ca was significantly higher after the intervention. The serum Phosphorus before and after the intervention in each group or between the two groups was not significant. CONCLUSIONS: The single 300,000 IM dose of vitamin D is regarded as an effective and safe to promptly improve vitamin D status in GDM. TRIAL REGISTRATION NUMBER: IRCT138902113840N1.