Effect of resveratrol administration on ovarian morphology, determined by transvaginal ultrasound for the women with polycystic ovary syndrome (PCOS).

Intake of resveratrol has been associated with improved ovarian morphology under in vitro and in the animal models; however, this finding has not been confirmed in trials. The aim of our study was, therefore, to use a placebo-controlled approach with the detailed assessment of the ovarian morphology by applying transvaginal ultrasound to examine the effectiveness of this therapeutic approach in this group of women. The mean age of all participants was 28·61 (sd 4·99) years, with the mean BMI of 28·26 (sd 5·62) kg/m2. Resveratrol therapy, as compared with placebo, was associated with a significantly higher rate of improvement in the ovarian morphology (P = 0·02). Women who received resveratrol had a more dominant follicle than those getting placebo, with a significant reduction in the ovarian volume (P < 0·05). However, the number of follicle count per ovary (FNPO), stromal area (SA), ovarian echogenicity and distribution of follicles were not significantly altered (P > 0·05). Forty-one women with polycystic ovary syndrome (PCOS) were randomly assigned (1:1) to 3 months of daily 1000 mg resveratrol or placebo. Random assignment was done by blocked randomisation. Our primary endpoints were the change in the ovarian volume, SA and antral FNPO from the baseline to 3 months. Secondary endpoints were improvement in the distribution of follicles and ovarian echogenicity. Differences between the resveratrol and control groups were evaluated by Chi-square, Fisher's exact test and repeated-measures ANOVA. Treatment with resveratrol significantly reduced the ovarian volume and polycystic ovarian morphology, thus suggesting a disease-modifying effect in PCOS.

The effect of synbiotics supplementation on anthropometric indicators and lipid profiles in women with polycystic ovary syndrome: a randomized controlled trial.

BACKGROUND: Different therapies have been suggested for polycystic ovary syndrome (PCOS), but changes in lifestyle and diet have been considered. Diet and dietary factors can be very effective in modifying the disease. The positive effects of probiotic and synbiotics supplementation on improving lipid profiles and anthropometric indices have been examined in various diseases. This study was conducted to evaluate the effects of synbiotics supplementation on lipid and anthropometric profiles in infertile women with PCOS. METHODS: PCOS patients aged 19-37 years old were randomized to receive either synbiotics supplement (n = 50) or placebo (n = 49) for 12 weeks. RESULTS: Consumption of synbiotics compared to the placebo, resulted in a significant decrease in Low-density lipoprotein cholesterol (LDL) value (Change Mean Difference (CMD): 4.66, 95%CI: 0.20, 9.13) and a significant increase in high-density lipoprotein cholesterol (HDL) (CMD: 1.80, 95%CI: 0.34, 3.26). Although we failed to find a significant effect of synbiotics consumption on total cholesterol (TC) and triglyceride (TG) levels. We did not find differences in anthropometric indices between groups. CONCLUSIONS: Overall, 12 weeks of synbiotics supplementation among PCOS women resulted in beneficial effects on LDL and HDL, although it is not yet clear how much our findings are clinically significant and more clinical studies with larger sample sizes are still needed. TRIAL REGISTRATION: Iranian Registry of clinical Trial, IRCT.ir, ID: IRCT2014110515536N2. Registered on 19 December 2015.

The Effect of Vitamin D Supplementation on Breast Density Changes: A Clinical Trial Study.

The aim of this study was to determine the effect of supplementation with 50,000 IU/monthly vitamin D for 1 yr on breast density in Iranian women. METHODS: This double-blind, placebo-controlled, single center clinical trial was conducted among 400 women aged 40 yr and older. Participants were allocated to 2 groups. Group 1 received vitamin D (Cholecalciferol) 50,000 IU in tablet form, monthly, for 1 yr. Group 2 received vitamin E 400 IU in tablet form, monthly, for the same period of time. Participants had follow-up clinic visits every 6 mo and received an annual mammogram. RESULTS: Final data were evaluated based on 216 and 194 women in the vitamin D and control groups. The mean decrease in mammographic density was -5.01%(95% CI, -9.9% to -0.01%) and -2.34 %(95% CI, -6.84% to -2.15%) in the vitamin D and control groups, respectively. There was no significant association between vitamin D consumption and breast density after 1 yr (OR = 0.7, 95% CI, 0.46 to 1.06; P = 0.1).Similar results were observed when multivariate model of logistic regression analysis was performed. CONCLUSIONS: This study showed that monthly consumption of 50,000 IU of vitamin D supplementation for 1 yr did not affect breast density.

Effects of synbiotic supplementation on metabolic parameters and apelin in women with polycystic ovary syndrome: a randomised double-blind placebo-controlled trial.

Polycystic ovary syndrome (PCOS) is one of the most common causes of infertility in women of reproductive age. Insulin resistance is a main pathophysiologic feature in these patients. According to some studies, the intake of probiotic bacteria may improve glucose homoeostasis. The aim of this study was to investigate the effect of synbiotics on metabolic parameters and apelin in PCOS patients. This randomised double-blind placebo-controlled trial was conducted on eighty-eight PCOS women aged 19-37 years old. The participants were randomly assigned to two groups receiving (1) synbiotic supplement (n 44), and (2) placebo (n 44) for 12 weeks. Fasting blood samples were taken at baseline and after 12 weeks. The two groups showed no difference in fasting blood sugar (adjusted mean difference: 0·60; 95 % CI -3·80, 5·00, P=0·727), plasma glucose fasting 2-h (adjusted mean difference 2·09; 95 % CI -9·96, 14·15, P=0·134), HbA1c (adjusted mean difference 0·06; 95 % CI -0·09, 0·22, P=0·959), homoeostatic model assessment-insulin resistance (HOMA-IR) (adjusted mean difference: 0·02; 95 % CI -0·99, 1·03, P=0·837), quantitative insulin sensitivity check index (QUICKI) (adjusted mean difference: -0·02; 95 % CI -0·33, 0·29, P=0·940) and C-reactive protein (CRP) (adjusted mean difference: 0·24; 95 % CI -1·61, 2·08, P=0·141) by the end of the intervention. A significant difference was observed in the mean apelin 36 before and after the intervention between synbiotic and placebo groups (adjusted mean difference: -4·05; 95 % CI -7·15, -0·96, P=0·004). A 12-week synbiotic supplementation has no significant beneficial effects on HOMA-IR and CRP in PCOS patients, whereas the level of apelin 36 significantly decreased.

Gestational diabetes mellitus its association with obesity: a prospective cohort study.

PURPOSE: The aim of this study was to investigate the association between pre-pregnancy body mass index (BMI) and gestational diabetes mellitus (GDM). METHODS: This prospective study was conducted on 256 pregnant women without diabetes referred for prenatal care in the first trimester of pregnancy to two referral University Hospitals (Shariati and Arash Hospitals) during the years 2012 and 2013. Eligible participants were selected consecutively and were followed until delivery and 6 weeks after that. Body weight and fasting plasma glucose were measured in each trimester, and BMI was calculated. Incidence of GDM was recorded, and BMI in this group was compared with those without GDM. RESULTS: Mean age of women was 28.70 ± 5.57 years and among them, 78 women (30.5 %) developed GDM of which 21 were obese (52.5 %), 25 overweight (27.8 %), and 32 (25.4 %) were normal weight (p = 0.004). Pre-pregnancy obesity (OR 2.74, 95 % CI 1.28-5.88, p = 0.009), family history of diabetes (OR 2.01, 95 % CI 1.13-3.56, p = 0.016), and maternal age more than 30 years (OR 2.20, 95 % CI 1.25-3.88, p = 0.006) were three independent predictors for GDM, and pre-pregnancy obesity was the most potent predictor of GDM. CONCLUSION: Women with high BMI and obesity have a significantly higher risk for developing GDM. Pre-pregnancy obesity, family history of diabetes, and age more than 30 years are three independent risk factors for GDM.

The effect of vitamin D on primary dysmenorrhea with vitamin D deficiency: a randomized double-blind controlled clinical trial.

Dysmenorrhea is common among women of reproductive age. This study aim was to investigate the effect of vitamin D (vit D) supplementation in treatment of primary dysmenorrhea with vit D deficiency. A randomized double-blind placebo-controlled clinical trial was conducted on 60 women with primary dysmenorrhea and vit D deficiency referred to our clinic at Arash Women's Hospital from September 2013 to December 2014. Eligible women were randomly assigned into treatment and control groups (30 in each group). Individuals in the treatment group received 50 000 IU oral vit D and the control group received placebo weekly for eight weeks. After two months of treatment, there was a significant difference in serum vit D concentration between the two groups (p < 0.001). Pain severity decreased significantly in treatment group after eight weeks of treatment. There was a significant difference in pain intensity between the two groups after eight weeks of treatment and one month after the end of treatment (p < 0.001 for both). A weekly high dose (50 000 IU) oral vit D supplementation for eight weeks in patients with primary dysmenorrhea and vit D deficiency could improve pain intensity.

Evaluation of Xerostomia and salivary flow rate in Hashimoto's Thyroiditis.

BACKGROUND: One of the most common causes of hypothyroidism is Hashimoto's Thyroiditis (HT). Early detection of dry mouth is critical in preserving and promoting systemic and oral health. In this study we have assessed, for the first time, salivary function and xerostomia in HT patients who have not been involved with Sjögren's syndrome. MATERIAL AND METHODS: HT was diagnosed in 40 patients based on clinical findings and positive anti-thyroid peroxidase antibodies (anti-TPO). Controls, matched by sex, age and body mass index (BMI), and with no history of thyroid disease, were selected. A questionnaire was used for diagnosis of xerostomia. Saliva samples were taken between 8 a.m. and 9 a.m., and at least 2 hours after the last intake of food or drink. The flow rate was calculated in milliliters per minute. RESULTS: Xerostomia was significantly higher in patients with HT. Unstimulated salivary flow rate was significantly lower in the HT group. Stimulated salivary flow rate was lower in HT group, but the difference was not significant. CONCLUSIONS: The patients with HT experienced xerostomia, and their salivary flow rate was diminished. Spitting the saliva then assessing salivary flow rate based on milliliter per minute is non-invasive, fast, and simple for chair-side diagnosis of dry mouth. Autoimmune diseases can be accompanied by salivary gland dysfunction. This may be due to the effect of cytokines in the autoimmune process or because of thyroid hormone dysfunctions.

Association between serum adropin levels and gestational diabetes mellitus; a case-control study.

Gestational diabetes mellitus (GDM) is increasing worldwide. The aim of this study was to investigate the association between serum adropin concentration and GDM. In a case-control study, conducted in 2013, 40 pregnant women with GDM and 40 healthy pregnant women (controls) were evaluated. Fasting serum adropin and lipid concentration were measured during 24th-28th weeks of gestation for both groups. These factors were compared between the two groups using independent sample t-test. There was a significant difference in adropin levels between the two groups and mean adropin levels were lower in GDM group (p: 0.016). There was no significant correlation between serum adropin levels and body mass index as well as fasting blood glucose (FBS) or serum lipid profile including high-density lipoprotein, low-density lipoprotein, cholesterol and triglyceride concentration (p > 0.05). There was a significant association between adropin concentration and GDM even after using regression model for removing confounding factors (odds ratio = 0.681). Low serum adropin concentration is associated with GDM in Iranian pregnant women.

Design and implementation of a national quality registry of thyroid cancer in Iran: study protocol.

Purpose: Thyroid cancer is recognized as the predominant form of endocrine cancer. The likelihood of cancer recurrence and the development of distant metastases varies depending on the cancer's pathology and stage. Iran currently lacks country-specific data on thyroid cancer, which can potentially result in clinicians deviating from the optimal treatment. The primary objectives of establishing such a registry are to determine the incidence, identify risk factors, and evaluate treatment outcomes for thyroid cancer within the Iranian population. Ultimately, the overarching goal of this protocol study is to reduce mortality and morbidity rates among thyroid cancer patients by implementing appropriate interventions based on the findings derived from this registration system. Methods: The study will enroll all individuals aged 18 years and older who have received a diagnosis of primary thyroid carcinoma based on pathology criteria. Data will be collected from various thyroid clinic centers. The participating centers include the Endocrinology Clinic at Shariati Hospital, the Thyroid Clinic in the Nuclear Medicine Center at Shariati Hospital, as well as pathology and nuclear medicine centers in Kerman and Bushehr. Patient records comprise information on outpatient visits to the clinic. Conclusion: The registry aims to enhance treatment approaches and follow-up protocols while serving as a foundation for conducting clinical, epidemiological, and basic science studies based on robust evidence-based data.

The approach of Iranian clinical pharmacists in the treatment of dyslipidemia based on international guidelines.

Introduction: Optimal treatment of dyslipidemia is a top priority in the prevention of cardiovascular diseases. For this purpose, clinicians in Iran usually refer to four current international guidelines. The aim of this study was to assess the approach of Iranian clinical pharmacists in the treatment of dyslipidemia based on international guidelines. Methods: A structured questionnaire was prepared. Questions (n=24) included the demographics (n=7), dyslipidemia references (n=3), dyslipidemia general knowledge of respondents (n=10), and questions (n=4) designed based on the difference among the latest version of guidelines participants stated they use in their practice. After validity conformation, the questionnaire was distributed to 120 clinical pharmacists, electronically from May to August 2021. Results: Response rate was 77.5% (n=93). The majority of participants (80.6%, n=75) claimed to have used the 2018 ACC/AHA guideline. The Median (interquartile range [IQR]) score of the general knowledge questions was 5.0 (2.0) out of 10. The Median (IQR) score of questions designed based on the difference among guidelines was calculated 3(1) out of 4. There was no significant (P=0.25) difference in score among participants according to their guideline selection. Moreover, the gender and length of experience as a clinical pharmacist had no significant (P>0.05) effect on the score of participants. Conclusion: In this study, Iranian clinical pharmacists answered half of the dyslipidemia general knowledge questions correctly. Also, Participants were up-to-date on 75% of the questions designed based on the latest version of the guideline they had been using in their practice.

Evaluation of important human CYP450 isoforms and P-glycoprotein phenotype changes and genotype in type 2 diabetic patients, before and after intensifying treatment regimen using Geneva cocktail.

The present study evaluates the influence of type 2 diabetes (T2D) on important CYP450 (CYP) isoforms and P-glycoprotein (Pgp) transporter activities before and 3 months after an intensifying treatment regimen involving 40 patients. Results have been compared with 21 non-T2D healthy participants (the control group). CYPs and Pgp activities were assessed after administering the Geneva cocktail. The mean metabolic ratios (MR) for CYP2B6 (1.81 ± 0.93 versus 2.68 ± 0.87), CYP2C19 (0.420 ± 0.360 versus 0.687 ± 0.558) and CYP3A4/5 (0.487 ± 0.226 versus 0.633 ± 0.254) significantly decreased in T2D patients compared to the control group (p < 0.05). CYP2C9 (0.089 ± 0.037 versus 0.069 ± 0.017) activities slightly increased in diabetic patients, and no difference was observed regarding CYP1A2 (0.154 ± 0.085 versus 0.136 ± 0.065), CYP2D6 (1.17 ± 0.56 versus 1.24 ± 0.83), and Pgp activities in comparison to the control group. Three months after the intensifying treatment regimen, MRs of CYP2C9 (0.080 ± 0.030) and CYP3A4/5 (0.592 ± 0.268) improved significantly and were not statistically different compared to the control group (P > 0.05). Several covariables, such as inflammatory markers (IL-1ß and IL-6), genotypes, diabetes and demographic-related factors, were considered in the analyses. The results indicate that chronic inflammatory status associated with T2D modulates CYP450 activities in an isoform-specific manner.

The hypoglycemic effects of Juglans regia L. internal septum in type 2 diabetic patients: A double-blind, randomized, placebo-controlled clinical trial.

Introduction: The internal septum of J.regia is traditionally used to control diabetes, and its effectiveness has been shown in animal studies. Accordingly, human clinical trials are needed to confirm its effectiveness on hemoglobin A1c (HbA1c), fasting blood sugar (FBS), blood insulin level, and insulin resistance as a complementary for better control of type 2 diabetes. Methods: This study was a randomized, double-blinded, controlled trial. The lyophilized powder of extract of the internal septum of J.regia was used to fill the capsules. Sixty type 2 diabetic patients were randomly divided into two groups. 500 mg capsules three times daily before meal was added to their routine drug regimen, and HbA1c, FBS, and blood insulin level were checked at the baseline and after three months. Results: Sixty patients completed the study. The mean(±SD) age of patients was 49.1(10.2) and 50.9(12.7) years in the placebo and J.regia groups, respectively. We observed that J.regia internal septum increases the level of HbA1c by about 0.02 units, but this effect was not significant (MD=0.02,95%CI=-0.36 to 0.40, P=0.93). Regarding the impact of capsules on insulin level, it seems that J.regia-containing capsules can raise insulin level by one unit. However, it was not significant (MD=1.01,95%CI=-0.86 to 2.88, P=0.28). As for FBS, it can cause a decrease of four units, but this effect is also not significant (MD=-3.98,95%CI=-18.33 to 10.37, P=0.58). Conclusion: Based on our study, the internal septum of J.regia has no significant effect on HbA1c, FBS, and insulin resistance. Moreover, no specific adverse reaction was observed in any of the patients.

Microbiome alterations in women with gestational diabetes mellitus and their offspring: A systematic review.

Aims: Gestational diabetes mellitus (GDM) is a metabolic disorder that might predispose pregnant women to develop type 2 Diabetes Mellitus or lead to severe adverse outcomes in their offspring. One of the factors that have been thought to be involved in the pathology behind this disorder is the microbiome. In this systematic review, we comprehensively review the documents regarding the microbiota alterations in different tracts of pregnant women with GDM and their offspring. Methods: A comprehensive search was conducted in major databases including MEDLINE (PubMed), Scopus, and Web of sciences up to August 2021. Data on the demographics, methodology, and microbiome alterations were extracted and classified according to the type of microbiome in pregnant women with GDM and their offspring. The quality of studies was assessed using the Newcastle-Ottawa Scale (NOS). Results: In 49 articles which were retrieved, the findings were variable on the level of changes in alpha and beta diversity, enrichment or depletion in phyla, genera, species and OTUs, in each microbiome type. Although there were some inconsistencies among the results, a pattern of significant alterations was seen in the gut, oral, vaginal microbiome of women with GDM and gut, oral, and placental microbiome of their offspring. Conclusion: Even though the alteration of the microbiome of the different tracts was seen in the cases of GDM, the inconsistency among the studies prevents us from identifying unique pattern. However, the results seem promising and further studies that overcome the confounding factors related to the demographics and methodology are needed.

The association between advanced glycation end products (AGEs) and ABC (hemoglobin A1C, blood pressure, and low-density lipoprotein cholesterol) control parameters among patients with type 2 diabetes mellitus.

BACKGROUND: Diabetes-induced chronic hyperglycemia results in the formation and aggregation of advanced glycation end-products (AGEs), which are products of non-enzymatic glycosylation of lipids or proteins. The development of diabetic complications can be accelerated by AGEs. In the current study, we aimed to explore the relationship between AGEs levels and ABC goals of diabetes control (A: Hemoglobin A1C < 7.0%, B: Blood pressure < 140/90 mmHg, and C: low-density lipoprotein cholesterol [LDL] < 100 mg/dL). METHODS: In the current cross-sectional study, 293 patients with type 2 diabetes mellitus (T2D), were enrolled. Demographic and clinical characteristics of the individuals were collected. AGEs levels were measured using quantitative fluorescence spectroscopy. Finally, the association of AGEs levels with patients' characteristics and ABC goals was assessed. RESULTS: Higher serum AGEs concentration was detected in older age, smoking patients and those with higher diastolic blood pressure, lower high-density lipoprotein (HDL) level, lower body mass index (BMI) and retinopathy. Moreover, the T2D patients who achieved higher numbers of ABC goals of diabetes were younger age (P-value = 0.003), with lower hemoglobin A1C (P-value = 0.001), fasting blood sugar (P-value = 0.002) diastolic blood pressure (P-value = 0.001), systolic blood pressure (P-value = 0.001), cholesterol (P-value = 0.001), LDL (P-value = 0.001), and AGEs (P-value = 0.023) levels. Diabetic patients with AGEs levels above 73.9% were about 2.2 times more likely to achieve none of ABC treatment goals (95% CI 1.107-3.616). CONCLUSION: Our results revealed the relationship between AGEs and ABC goal achievement, and microvascular diabetic complications, and imply that AGEs measurement may be valuable in the monitoring of diabetic patients' complications and treatment adjustment.

Serum Prooxidant-Antioxidant Balance and hs-CRP in Patients with Clinical and Subclinical Hypothyroidism.

Background: Oxidative stress (OS) is caused by an imbalance between prooxidant substance production and antioxidant defense. OS is involved in physiologic interactions in the body and the pathogenesis of various disorders. This study aimed to evaluate serum prooxidant-antioxidant balance (PAB) as a selective prooxidant, antioxidant defense, and acute phase reactant protein in patients with subclinical and clinical hypothyroidism. Methods: This case-control study was conducted in three groups including clinical hypothyroidism (32 patients), subclinical hypothyroidism, (42 cases), and healthy controls (32 individuals). This study was performed in the Endocrine Clinic of Arash Training and Research Hospital, Tehran, 2017. In the study groups, thyroid hormones including T4 and Thyroid Stimulating Hormone (TSH), fasting blood glucose (FBG), lipid profile, PAB, and hs-CRP as inflammatory markers were measured and compared between the groups. Results: Among 106 participants, 95.3% were females, the gender balance was similar across groups and mean age was 30.79 ± 7.65 years. FBG and lipid profile except for cholesterol level were not significantly different between the three study groups. However, cholesterol level in the clinical hypothyroid group was significantly higher than the other two groups. PAB was higher in subclinical hypothyroidism compared to healthy controls after adjustment for age and TSH levels (P value: 0.04) but there was no significant difference in the clinical hypothyroid group in comparison with healthy controls. In addition, there was no significant difference in high-sensitivity C-reactive protein (hs-CRP) between the three study groups. Conclusions: This study suggests that that subclinical hypothyroidism increases PAB in comparison to healthy control which could indicate OS response in patients with subclinical hypothyroidism, respectively.

Diabetes-related distress and its association with the complications of diabetes in Iran.

Purpose: Diabetes-related distress (DRD) has negative emotional effects on the patients' quality of life. This is while the condition often goes undiagnosed despite it being common among diabetic patients. This study investigated the prevalence of DRD and its association with diabetes complications among a group of Iranian type 2 diabetic patients (T2DM). Methods: This descriptive-analytical cross-sectional study was conducted on 186 T2DM patients referred to a diabetes clinic in a teaching hospital from the beginning of May 2019 to the end of April 2020. Two questionnaires on disease-related information and diabetes distress screening scale (DDS) were filled out for each patient. The latter was divided into four domains, emotional burden (EB), diabetes-related interpersonal distress (ID), physician-related distress (PD), and regimen-related distress (RD). In addition to the frequency of DRD and its association with age, sex, body mass index (BMI), hypertension, hemoglobin A1C, duration of disease, and type of medication regimen (oral, insulin, or mix) along with the history of cardiovascular disease (CVDs), retinopathy, nephropathy, and diabetic foot were assessed. Results: DRD was reported in 47% of the patients. Being female, old age, hypertension, high hemoglobin A1C levels, nephropathy, and retinopathy were significantly associated with DRD (P-value = < 0.001, 0.013, 0.014, 0.007, 0.001, and 0.004, respectively). The history of the diabetic foot had a significant relationship with PD and ID (P-value = 0.007 and < 0.001, respectively). Multivariate regression showed gender and the existence of complications to have a direct effect on the development of DRD. Conclusion: DRD prevalence is relatively high and requires screening to identify and treat high-risk patients. Further studies are needed to study diabetes, its complications and their relation with DRD to help reduce such conditions and improve the patient's quality of life.

Preventive effect of probiotics supplementation on occurrence of gestational diabetes mellitus: A systematic review and meta-analysis of randomized controlled trials.

Background: Gestational diabetes mellitus (GDM) is a health challenge during pregnancy and is associated with adverse effects. Dysbiosis of the gut microbiota may play a role in developing inflammation and insulin resistance observed in GDM. Probiotics are supposed to be influential in preventing GDM since they can alter the composition of microbiota in the intestine. Despite the existing studies on the therapeutic effects of probiotics in women with GDM, in this study we aim to systematically review and meta-analyze the results of randomized control trials (RCTs) on the beneficial effects of probiotics supplements on the prevention of GDM in healthy pregnant women. Methods: Web of science, Scopus and PubMed databases were searched via a precise strategy to gather RCTs related to our study. Duplication removal, screening and data extraction were conducted by two researchers, independently. Quality assessment of eligible studies was conducted by Cochrane risk of bias tool. Meta-analysis was conducted using the random effects model due to substantial heterogeneity among studies. Results: Ten articles met our eligibility criteria from our initial search of 451 articles. Two thousand nine hundred and twenty-one participants without previously diagnosed glucose disturbance were included in our analysis. Probiotics reduced GDM incidence by 33% (RR = 0.67, 95% CI: 0.47, 0.95), while greater effect was detected in trials using multiple-strains probiotics (RR = 0.65, 95% CI: 0.42, 0.99). We did not detect any significant benefits or harms related to probiotics supplements on secondary outcomes including GDM related infantile and maternal complications including preeclampsia, caesarian section, mothers' weight gain during pregnancy, prematurity, macrosomia, hypoglycemia, NICU admission, and birth weight. Conclusion: Probiotics supplementation may reduce the incidence of GDM and help control glucose parameters in pregnant women. Further studies are warranted regarding the GDM-related maternal and infantile complications. Systematic review registration: https://www.crd.york.ac.uk/prospero/display_record.php?ID=CRD42022315550, identifier: CRD42022315550.

Aspirin versus placebo on estrogen levels in postmenopausal women: a double-blind randomized controlled clinical trial.

BACKGROUND: Estrogen is involved in the pathogenesis of breast and gynecological cancers. Regular use of aspirin reduces estrogen levels. The present study aimed to evaluate the effect of aspirin on estrogen levels in postmenopausal women. METHODS: This double-blind, placebo-controlled parallel-group trial was conducted on postmenopausal women referred to an outpatient clinic at a women's hospital in Tehran. Volunteers were randomly assigned to receive aspirin 100 mg/day or placebo for 6 weeks. Estradiol, sex hormone-binding globulin (SHBG), and testosterone levels at baseline and at the end of the intervention were measured by ELISA. Data were analyzed using SPSS 20, Kolmogorov-Smirnov test, independent samples t-test, and Mann-Whitney U test. RESULTS: Twenty-seven and 28 participants were finally analyzed in the aspirin and placebo groups, respectively. There was no significant difference between the two groups in body mass index (BMI), age, or menopausal years. There was a statistically significant difference (p = 0.002) in the amount of  change in estradiol levels of the intervention group (median=- 3.5 pg/ml) compared to the control group (median=1.5 pg/ml). In contrast, there were no significant differences between the two groups regarding testosterone and SHBG levels (p = 0.58, p = 0.32). CONCLUSIONS: Since low doses of aspirin may decrease estradiol levels, it could be considered a promising adjunctive therapeutic candidate in postmenopausal women to decrease BC incidence. However, further studies with larger sample sizes, measurements of estrogen levels and its related compounds in different time points accompanied by long-term follow-ups are needed to better elucidate the potential mechanisms by which nonsteroidal anti-inflammatory drugs (NSAIDs) negatively affect breast cancer. TRIAL REGISTRATION: IRCT201012195397N1. Date of first registration: 03/01/2011.

Effect of daily consumption of probiotic yoghurt on albumin to creatinine ratio, eGFR and metabolic parameters in patients with type 2 diabetes with microalbuminuria: study protocol for a randomised controlled clinical trial.

INTRODUCTION: To alleviate clinical symptoms of diabetic nephropathy (DN), several dietary and non-dietary strategies have been suggested. Probiotic-enriched foods, through their effects on modulating microflora, might help these patients control the adverse effects. The current study will be done to examine the effects of probiotic yoghurt consumption on albumin to creatinine ratio, estimated glomerular filtration rate (eGFR) and metabolic parameters in patients with type 2 diabetes with nephropathy. METHODS AND ANALYSIS: Sixty patients with DN will be recruited in this study. After block matching for sex, body mass index and age, patients will be randomly assigned to receive 300 g/day probiotic yoghurt containing 106 CFU/g Lactobacillus acidophilus and Bifidobacterium lactis strains or 300 g/day plain yoghurt daily for 8 weeks. Weight, height and waist circumference will be measured at study baseline and after the intervention. Biochemical indicators including glycaemic measures (haemoglobin A1c (HbA1c), fasting blood sugar (FBS)), inflammatory markers (high sensitivity-C reactive protein), lipid profile (total cholesterol (TC), triglyceride (TG), low-density lipoprotein (LDL), high-density lipoprotein (HDL)) and finally renal makers (creatinine, albumin to creatinine ratio, eGFR) will be assessed at study baseline and at the end of the trial. DISCUSSION: Improving the condition of a person with DN is a serious clinical challenge. The use of probiotic supplements has been considered in these people, but the use of probiotic-enriched foods has received less attention. TRIAL REGISTRATION NUMBER: Iranian Registry of Clinical Trials (www.irct.ir) (IRCT20201125049491N1).