Effect of oral magnesium supplement on cardiometabolic markers in people with prediabetes: a double blind randomized controlled clinical trial.

To evaluate the effect of magnesium supplementation on insulin resistance and cardiovascular markers in people with prediabetes. A 12 week double-blind placebo-controlled randomized clinical trial was conducted at Isfahan Endocrine and Metabolism Research Center, Iran, on people with prediabetes (n = 86) to compare the effects of magnesium oxide 250 mg/day versus a placebo on anthropometric indices, blood pressure, fasting glucose, insulin, HOMA-IR index, C-reactive protein, uric acid and lipid profile. Both groups had similar distributions of anthropometric and biochemical variables at baseline. Those who received magnesium supplementation had significantly higher levels of HDL-cholesterol compared to the placebo group at the end of the study (49.7 ± 10.9 vs 43.6 ± 7.2 mg/dL, P = 0.003). The mean changes of HOMA-IR index, total cholesterol, LDL-cholesterol, triglyceride, uric acid and C-reactive protein levels as well as anthropometric indices and blood pressure in supplemented and placebo groups did not differ significantly. Magnesium supplementation increased HDL-cholesterol levels in people with prediabetes. However, other cardiometabolic markers were not improved by magnesium supplementation at the above dosage and duration.

Probiotic and synbiotic supplementation could improve metabolic syndrome in prediabetic adults: A randomized controlled trial.

AIMS: Modulation of the gastrointestinal microbiome is suggested to contribute to the progression of metabolic syndrome associated diseases. This study was designed to assess the effects of probiotics and synbiotics on metabolic syndrome in individuals with prediabetes. METHODS: 120 adults with prediabetes were enrolled in a double-blind, placebo-controlled randomized parallel-group clinical trial. Participants were randomized to a multi-species probiotic or inulin-based synbiotic or placebo. Blood samples and anthropometric measures were collected at baseline, 12 and 24 weeks after treatment. The primary outcome measures were the changes between groups in metabolic syndrome and its components' prevalence. RESULTS: A significant trend for a reduction in the prevalence of hyperglycemia in probiotic and synbiotic groups (p = 0.01 and 0.005 respectively), and hypertension in probiotic group (p = 0.04) was found. The decreases in metabolic syndrome prevalence were significant after taking probiotic and synbiotic supplementation as compared with placebo (p = 0.02). Also, the prevalence of low HDL-cholesterol level was decreased during the study in the probiotic group compared with placebo (p = 0.02). CONCLUSIONS: The potential benefits of using probiotic and synbiotic for metabolic syndrome management in prediabetes have been supported by the results in the current study which might provide an important strategy to combat metabolic syndrome-associated diseases.

The effects of probiotics and synbiotic supplementation on glucose and insulin metabolism in adults with prediabetes: a double-blind randomized clinical trial.

AIMS: Probiotics and/or prebiotics could be a promising approach to improve metabolic disorders by favorably modifying the gut microbial composition. OBJECTIVES: To assess the effects of probiotics and synbiotic on glycemic indices in prediabetic individuals who are at risk of type 2 diabetes and its complications. METHODS: In a double-blind, randomized, placebo-controlled parallel-group clinical trial, 120 prediabetic adults participated and were randomly allocated to receive either probiotics or synbiotic or placebo supplements for 24 weeks. Anthropometric measurements, food record, physical activity and glycemic biomarkers including glycated hemoglobin (HbA1C), fasting plasma glucose (FPG), fasting insulin levels (FIL), homoeostasis model assessment for insulin resistance (HOMA-IR), quantitative insulin sensitivity check index (QUICKI), and ß-cell function (HOMA-B) were assessed at baseline and repeated at 12 and 24 weeks and compared within and between three groups using repeated measure ANOVA. RESULTS: Compared with the placebo, synbiotic supplementation resulted in a higher significant reduction in FPG (- 6.5 ± 1.6 vs. - 0.82 ± 1.7 mg/dL, P = 0.01), FIL (- 2.6 ± 0.9 vs. - 0.8 ± 0.8 µIU/mL, P = 0.028), and HOMA-IR (- 0.86 ± 0.3 vs. - 0.16 ± 0.25, P = 0.007), and a significant elevation in the QUICKI (+ 0.01 ± 0.003 vs. + 0.003 ± 0.002, P = 0.006). In addition, significant decreases in HbA1C was seen following the supplementation of probiotics and synbiotic compared with the placebo (- 0.12 ± 0.06 and - 0.14 ± 0.05 vs. +0.07 ± 0.06%, P = 0.005 and 0.008, respectively). HOMA-B was not found to be different between or within the three groups. CONCLUSION: Glycemic improvement by probiotics and particularly synbiotic supplements in prediabetic individuals has been supported by current study. However, further studies are required for optimal recommendations in this important area of patient treatment. TRIAL REGISTRATION: Iranian Registry of Clinical Trials: IRCT201511032321N2, Date registered February 27, 2016.

The Effect of Levothyroxine and Selenium versus Levothyroxine Alone on Reducing the Level of Anti-thyroid Peroxidase Antibody in Autoimmune Hypothyroid Patients.

BACKGROUND: Due to the prevalence of autoimmune hypothyroidism and its effects on physical and mental health it is necessary to provide a treatment which is also effective in preventing the progression of sub-clinical hypothyroidism in these patients. This study aims to investigate the effect of selenium supplementation on of anti-thyroid hormone antibodies in these patients. MATERIALS AND METHODS: In a randomized clinical trial, 70 patients with autoimmune hypothyroidism randomly divided into two groups of 35 each, the first group was treated with oral selenium treatment with levothyroxine (LT4) and to the second group along with LT4, placebo was also prescribed. Serum selenium level, thyroid hormones and anti-thyroid hormone antibodies before and after 3 months of treatment in both groups, were determined, and the results were analyzed using SPSS software. RESULTS: The mean of the serum anti-thyroid peroxidase serum level in the intervention group before and after treatment was 682.18 ± 87.25 and 522.96 ± 47.21 and the difference before and after treatment was statistically significant (P = 0.021). The level of this antibody before and after treatment in the control group was 441 ± 53.54 and 501.18 ± 77.68, and no significant differences between two groups were observed before and after treatment (P = 0.42). CONCLUSION: Selenium supplementation may help to reduce the levels of antibodies in patients with autoimmune hypothyroidism.

Prevalence of vitamin D deficiency among adult population of Isfahan City, Iran.

Determination of vitamin D status in different age-groups in a community and in different climates of a country is necessary and has important implications for general health. The study was conducted to determine the prevalence of vitamin D deficiency among the adult population of Isfahan, a centrally-located city in Iran. In this cross-sectional study, 1,111 healthy people-243 men and 868 women--aged 41.4 (mean 14 and range 20-80) years, who attended a single-consultation outpatient clinic, were selected. Serum 25-hydroxy vitamin D (25-OHD), parathyroid hormone (PTH), calcium and phosphorus concentrations were measured. Mild, moderate and severe vitamin D deficiencies were defined as 25-OHD values of 20-30 ng/mL, 10-20 ng/mL, and < 10 ng/mL respectively. The median (range) concentrations of 25-OHD were 21 (4.0-105.0) ng/mL in males and 18 (1.5-117) ng/mL in females (p = 0.05). The prevalence of mild, moderate and severe vitamin D deficiencies among the adult population was 19.6%, 23.9%, and 26.9% respectively. Vitamin D deficiency was more prevalent among women (p = 0.001) and younger age-group (p = 0.001). Medians of 25-OHD in spring-summer and autumn-winter were 21 ng/mL and 18 ng/mL respectively (p = 0.005). The prevalence of severe vitamin D deficiency was higher in autumn-winter than in spring-summer (odds ratio = 1.6, 95% confidence interval 1.2-2.2, p = 0.001). The prevalence of vitamin D deficiency was high in a sunny city--Isfahan--especially among women and younger population. The high prevalence of vitamin D deficiency in this city emphasizes the necessity of vitamin D supplementation as more exposure to sun is limited due to the type of clothing required by current law.

Effect of zinc supplementation on serum homocysteine in type 2 diabetic patients with microalbuminuria.

OBJECTIVES: Elevated homocysteine levels are considered to be an independent risk factor for cardiovascular complications in diabetic patients. The aim of this study was to find out if zinc supplementation improves homocysteine levels, which may exert vascular-protective effects in type 2 diabetes subjects with microalbuminuria. METHODS: In a randomized, double-blind, controlled, crossover study, 50 type 2 diabetic patients with microalbuminuria were subdivided into two groups and supplemented with 30 mg/d of zinc (group 1) or placebo (group 2) for three months with a four-week wash out period. Serum creatinine, vitamin B(12), folate, fasting plasma glucose, HbA1c, lipid profiles, zinc, homocysteine levels and random urine albumin were measured before and after the first and second phase of the study in all participants. RESULTS: Mean serum zinc was significantly increased after zinc supplementation (from 76 +/- 16 mug/dl to 93 +/- 20 microg/dl; p < 0.05), while there was no change in the placebo group (75 +/- 16 microg/dl to 75 +/- 15 microg/dl). With zinc supplementation, homocysteine levels reduced significantly (from 13.71 +/- 3.84 mumol/l to 11.79 +/- 3.06 mumol/l; p < 0.05), which did not occur on placebo (from 12.59 +/- 2.13 mumol/l to 13.36 +/- 2.03 mumol/l). Simple regression was used to show a positive correlation between urine albumin excretion and serum homocysteine (r = 0.37, p = 0.023). Vitamin B(12) and folate levels increased significantly in patients who received zinc in comparison to those who received placebo. A negative correlation was observed between homocysteine and vitamin B(12) concentration (r = -0.36, p = 0.025). CONCLUSION: Zinc supplementation reduced serum homocysteine and increased vitamin B(12) and folate concentrations in type 2 diabetic patients with microalbuminuria.

Zinc status in goitrous school children of Semirom, Iran.

BACKGROUND: Iodine deficiency produces the spectrum of iodine deficiency disorders (IDDs) including endemic goiter, hypothyroidism, cretinism and congenital anomalies. Other factors, including goitrogens and micronutrient deficiencies may influence the prevalence and severity of IDDs and response to iodine supplementation. An association between zinc and goiter has previously been reported. METHODS: A cross sectional study investigating an association between goiter and serum zinc status was performed in 2003 in a mountainous region of Iran. One thousand eight hundred twenty-eight children were selected by multistage cluster sampling. Goiter staging was performed by inspection and palpation. Serum zinc, total thyroxine, thyroid stimulating hormone and urinary iodine concentration were measured in a group of these children. RESULTS: Thirty six and seven tenth percent of subjects were classified as goitrous. Serum zinc level in goitrous and nongoitrous children was 82.80 ± 17.85 and 83.38 ± 16.25 µg/dl, respectively (p = 0.81). The prevalence of zinc deficiency (serum zinc ≤65 µg/dl) in goitrous and nongoitrous children did not differ significantly (9.3 % vs. 10.8%, p = 0.70). CONCLUSIONS: Goiter is still a public health problem in Semirom. According to the present study zinc status may not play a role in the etiology of goiter in Semirom school children. However, the role of other goitrogens or micronutrient deficiencies should be investigated in this region.

Effect of zinc supplementation on microalbuminuria in patients with type 2 diabetes: a double blind, randomized, placebo-controlled, cross-over trial.

OBJECTIVES: Oxidative stress can contribute to microvascular complications in diabetes. A decisive event associated with this condition may be the decrease in the synthesis of zinc-containing antioxidant enzymes such as superoxide dismutase and glutathione peroxidase. This consideration led us to investigate the effect of zinc supplementation versus placebo on microalbuminuria in diabetic patients in a randomized double blind clinical trial. METHODS: Fifty diabetic patients with microalbuminuria were enrolled. Fasting plasma glucose, HbA1c, lipid profiles, plasma zinc levels and random urine for albumin and creatinine were measured. Patients randomly received 30 mg elemental zinc (group 1) or placebo (group 2) for 3 months. After a 4 week wash-out period, the groups were crossed over (i.e. the zinc group were given placebo, and the placebo group were given zinc) and the protocol was repeated. RESULTS: From an initial number of 50 selected patients (25 in each of two groups), 39 patients (21 in group 1 and 18 in group 2) completed the study. In group 1, after zinc supplementation, urinary albumin excretion decreased significantly from 86.5 +/- 57 to 75 +/- 71 mg/g (p = 0.01). After placebo, patients in group 1 showed no significant reduction in microalbuminuria (85 +/- 72 mg/g to 83 +/- 63 mg/g creatinine). In group 2, no change in albumin excretion was observed after placebo treatment (90.5 +/- 63 mg/g to 90 +/- 60 mg/g creatinine). After zinc supplementation, a significant reduction was observed in albumin excretion, from 90 +/- 60 mg/g to 85 +/- 57 mg/g creatinine (p = 0.003). CONCLUSIONS: Zinc supplementation reduced albumin excretion in microalbuminuric type 2diabetic patients. This outcome may be due to the antioxidant effect of zinc.

Endemic goiter in Semirom; there is no difference in vitamin A status between goitrous and nongoitrous children.

BACKGROUND: Despite long-standing iodine supplementation in Iran, the prevalence of goiter remains high in some areas. This suggests other nutritional deficiencies may be considered as responsible factors for goiter persistence. In the present study we investigated the possible role of vitamin A deficiency (VAD) and low vitamin A status in the etiology of endemic goiter in Semirom, Iran. MATERIALS AND METHODS: In this cross-sectional study, 1,828 students from 108 primary schools of urban and rural areas of Semirom were selected by multistage random cluster sampling. Thyroid size was estimated in each child by inspection and palpation. Urinary iodine concentration (UIC) and serum retinol (SR) were measured. RESULTS: Overall, 36.7% of schoolchildren had goiter. The median UIC was 18.5 microg/dL. The mean+/-SD of SR in goitrous and nongoitrous children was 38.84+/- 10.98 and 39.17+/-10.85 microg/dL respectively (p=0.82). There were two children with VAD (SR less than 20 microg/dL); one in the goitrous and one in the nongoitrous group. The prevalence of subjects with low vitamin A status (SR less than 30 microg/dL) in the goitrous and nongoitrous groups was 26.2 and 21.5% respectively (p=0.42). CONCLUSION: Goiter is still a public health problem in this region. Iodine deficiency, VAD or low vitamin A status is not among the contributors of goiter persistence in schoolchildren of Semirom. The role of other micronutrient deficiencies or goitrogens should be investigated.

High prevalence of goiter in an iodine replete area: do thyroid auto-antibodies play a role?

INTRODUCTION: Despite long standing iodine supplementation in Iran the prevalence of goiter remains high in some areas. This may suggest that causes other than iodine deficiency, such as autoimmune thyroid diseases, should also be considered. We therefore assessed the prevalence of anti-thyroid antibodies in children living in an inland area in Iran and correlated these findings with prevalence of goiter within this region. METHODS: In a cross-sectional study, 1948 students were selected by multistage random cluster sampling from the 108 primary schools (age, 7-13 year-old) of the urban and rural areas of Semirom. After obtaining written consent from their parents, the children were examined by endocrinologists for goiter grading. Grade 2 goitrous children (108 cases) were compared with non-goitrous children (111 children as control group) for anti-thyroid antibodies. RESULTS: Overall, 36.7% of 1948 students had goiter. The mean urinary iodine excretion level was 1.49+/-0.7 micromol/L. This was within normal limits. Of 219 children studied, 4.3% presented with subclinical hypothyroidism, and 7.3% had positive anti-thyroid antibodies. There was non-significant difference of positive thyroperoxidase antibody (anti-TPO) (Odds Ratio= 3.2, p= 0.13) but significant difference of anti Tg between goitrous and non goitrous children (Odds Ratio: 5.6, 95% CI: 1.18-26.0, p: 0.015). CONCLUSION: This study suggests that autoimmunity may be one of the mechanisms responsible for goiter persistence after iodine replenishment in this iodine deficient region, but the role of other factors should also be considered.

Iron deficiency in goitrous schoolchildren of Semirom, Iran.

BACKGROUND: Iodine deficiency produces the spectrum of iodine deficiency disorders (IDDs): endemic goiter, hypothyroidism, cretinism, and congenital anomalies. Other factors, including goitrogens and micronutrient deficiencies, may influence the prevalence and severity of IDDs and response to iodine supplementation. This cross-sectional, descriptive study was performed in 2003 on elementary school children of Semirom, a mountainous region of Iran, where goiter was hyper-endemic in 1994, but the goiter prevalence had not decreased as expected many years after salt iodization and iodine injection. Some possible risk factors associated with goiter in that area were evaluated, and the results of iron study are presented here. METHODS: 1,869 cases were selected by a multistage cluster sampling procedure. Grade 2 goitrous children were compared with equal number of nongoitrous children for serum iron, ferritin, transferrin, thyroxin, TSH and urine iodine concentrations (UIC). RESULTS: 210 children (105 goiter grade 0 and 105 goiter grade 2) entered this sub-study. Of 210 participants, 70 children had low transferrin saturation, 13 had low serum ferritin and 9 children had both problems. There was no significant difference in goiter rate between children with low iron indices and others. There was no significant correlation between serum iron, ferritin or transferrin saturation with other variables including T4, UIC and goiter stage. CONCLUSION: The present study reveals that in the area studied, iron deficiency cannot explain the high prevalence of goiter, so other responsible factors should be investigated.

Iodine repletion, thyrotoxicosis and atrial fibrillation in Isfahan, Iran.

BACKGROUND: Iodized salt was reintroduced in Iran in 1989. Just before distribution of iodized salt, thyrotoxicosis was observed in 3.7% of the patients with atrial fibrillation (AF) in university teaching hospitals in Isfahan, a centrally located city in Iran. As repletion of iodine may increase the rate of autoimmune thyroid diseases and toxic multinodular goiter, this study was designed to evaluate the rate of thyrotoxicosis in patients with AF in the same hospitals after about a decade of iodized salt consumption. METHODS: In a case-control study with convenience sampling, 100 patients with AF and an equal number of age- and sex-matched subjects taking the same medications were selected as case and control groups, respectively, in university hospitals in 1997. RESULTS: Eight percent of patients with atrial fibrillation had overt thyrotoxicosis versus one percent in the control group (odds ratio=8.6, 95% CI = 6.5 to 10.7, P<0.02). Thyrotoxicosis in patients with AF was 8 times higher than in the control group without AF. In comparison with the period before use of iodized salt, AF more than doubled (8% vs. 3.7%). CONCLUSION: Thyroid function should be evaluated in all patients older than 40 years of age with AF. The benefits of iodine supplementation are great, but more attention should be paid to the complications of iodine repletion, including thyrotoxicosis and its frequent accompaniment, AF.