Factors associated with progression to pre-diabetes: a recurrent events analysis.

AIMS: Pre-diabetes is a strong risk factor for type 2diabetes (T2D). The aim of this study was to explore factors associated with normal glucose maintenance and pre-diabetes prevention or delay. METHODS: Data of 1016 first-degree relatives of T2D patients were retrieved from the Isfahan Diabetes Prevention Study (IDPS). Association of various variables including nutrients, serum tests and physical activity with the risk of pre-diabetes was assessed using recurrent events approach. RESULTS: Cumulative incidence of diabetes was 8.17, 9.44, and 4.91% for total sample and individuals with and without pre-diabetes experience in the follow-up. Risk of progression to pre-diabetes was higher in women and older people (p < 0.01). Additionally, BMI and blood pressure had significant association with the risk (p < 0.01) and individuals with higher intake of fat were at higher risk (HR = 2.26; 95% CI 1.66-3.07 for high-intake and HR = 1.52; 95% CI 1.27-1.83 for medium-intake compared to low-intake group). Carbohydrates and protein intake were positively associated with the risk of pre-diabetes with HR = 8.63 per 49 g extra carbohydrates per day and HR = 1.32 per 6 g extra protein per day (p < 0.01). The association was also significant for triglyceride (TG) with 7% risk increase per 1 SD = 1.14 increase in TG level. CONCLUSION: Despite frequent studies on lifestyle modification for pre-diabetes prevention, less information is available about the role of nutritional components. We observed direct effects for intake of macronutrients including fat, carbohydrates, and protein in first-degree relatives. Further research is warranted to assess these associations in general populations. LEVEL OF EVIDENCE: Level III: Evidence obtained from a single-center cohort study.

Effects of Legume-Enriched Diet on Cardiometabolic Risk Factors among Individuals at Risk for Diabetes: A Crossover Study.

AIMS: First-degree relatives of patients with diabetes are at high risk for chronic diseases, including type 2 diabetes and obesity. Our purpose was to determine the effects of consuming 4 servings of legumes per week on lipid profiles, glycemic indices, and blood pressure of participants with family history of diabetes over 6 weeks of intervention. METHODS: A total of 26 first-degree relatives of patients with diabetes (14 women and 12 men) participated in this randomized crossover clinical trial study. Participants were randomly assigned to a legume-enriched diet or habitual diet for 6 weeks. Paired t test and repeated measures analysis of variance were used to compare data for the 2 experimental diets. RESULTS: The mean ± SE of legumes intake during the legume phase was 111.12 ± 10.53 g/day that was significantly higher (p < 0.001) than the amounts of legumes during habitual diet (50.73 ± 7.10 g/d). Percentage changes for cardiovascular disease risk factors did not change significantly following 6 weeks of legume consumption. CONCLUSIONS: Consumption of 4 servings of legumes per week had no significant effect on anthropometric measurements, glycemic indices, and lipid profiles of participants with family history of diabetes, though it could reduce systolic and diastolic blood pressure at a marginally significant level.

Effects of Calcium Plus Vitamin D Supplementation on Anthropometric Measurements and Blood Pressure in Vitamin D Insufficient People with Type 2 Diabetes: A Randomized Controlled Clinical Trial.

BACKGROUND: Up to 75% of the risk of type 2 diabetes is attributable to obesity. Therefore, finding a way to control obesity can be useful for management of diabetes. OBJECTIVE: This study was performed to assess the effects of vitamin D3 and calcium supplementation on anthropometric measurements and blood pressure in vitamin D insufficient people with type 2 diabetes. METHODS: One hundred eighteen patients with diabetes were enrolled in this randomized placebo-controlled clinical trial. All subjects were randomly assigned into 4 groups receiving (1) 50,000 IU/wk vitamin D3 plus (equal to 7143 IU/d) calcium placebo; (2) 1000 mg/d calcium plus vitamin D3 placebo; (3) 50,000 IU/wk vitamin D3 (equal to 7143 IU/d) plus 1000 mg/d calcium; or (4) vitamin D3 placebo plus calcium placebo for 8 weeks. Anthropometric measurements and blood pressure were assessed at study baseline and after 8 weeks of intervention. RESULTS: A greater reduction in body mass index was observed in calcium plus vitamin D group than other groups (p = 0.03). Comparison of changes in waist circumference among 4 groups revealed no significant difference in crude model (p = 0.21) and when the effect of confounders was taken into account (p = 0.08). Calcium supplementation resulted in a significant reduction in hip circumference compared to other groups (p <0.001). Systolic blood pressure significantly decreased in the calcium plus vitamin D group compared to placebo (-7.3 ± 8.7 mmHg vs 0.5 ± 8.2 mmHg; p = 0.001). However, calcium and vitamin D supplementation had no significant effects on diastolic blood pressure. CONCLUSION: Calcium-vitamin D3 cosupplementation can have beneficial effect on body mass index (BMI), hip circumference, and systolic blood pressure in vitamin D-insufficient type 2 diabetics.

The effect of purslane seeds on glycemic status and lipid profiles of persons with type 2 diabetes: A randomized controlled cross-over clinical trial.

BACKGROUND: We are aware of limited data about the effects of purslane on diabetes. Earlier studies have mostly indicated the beneficial effects in animal models. This study aimed to evaluate the effect of purslane seeds on glycemic status and lipid profiles of persons with type 2 diabetes. MATERIALS AND METHODS: This cross-over randomized controlled clinical trial was conducted on 48 persons with type 2 diabetes. Participants were randomly assigned to receive either 10 g/day purslane seeds with 240 cc low-fat yogurt (intervention group) or only 240 cc low-fat yogurt (as a control group) for 5 weeks. After a 2-week washout period, subjects were moved to the alternate arm for an additional 5 weeks. At baseline and end of each phase of the study, fasting blood samples were collected to quantify plasma glucose levels, as well as serum insulin and lipid profiles. Within-group and between-group changes in anthropometric measures, as well as biochemical indicators, were compared using a paired-samples t-test. RESULTS: Mean age of study participants was 51.4 ± 6.0 year. We found a significant reduction in weight (-0.57 vs. 0.09 kg, P = 0.003) and body mass index (-0.23 vs. 0.02 kg/m(2), P = 0.004) following purslane seeds consumption. Despite a slight reduction in fasting plasma glucose levels (-2.10 vs. -2.77 mg/dL, P = 0.90), we failed to find any significant effect on serum insulin levels and homeostatic model of assessment of insulin resistance score. Furthermore, purslane consumption decreased serum triglyceride levels (-25.5 vs. -1.8 mg/dL, P = 0.04) but could not affect serum high-density lipoprotein cholesterol, low-density lipoprotein cholesterol, and total cholesterol levels. We observed a significant reduction in systolic blood pressure (-3.33 vs. 0.5 mmHg, P = 0.01) and a borderline significant decrease in diastolic blood pressure (-3.12 vs. -0.93 mmHg, P = 0.09) after purslane seeds intake. CONCLUSION: In summary, consumption of purslane seeds for 5 weeks in persons with type 2 diabetes might improve their anthropometric measures, serum triglyceride levels, and blood pressure. Further studies are required to determine the appropriate dosage for these patients.

Trends of diabetic nephropathy prevalence in Isfahan, Iran, during 1992-2010.

BACKGROUND: Diabetes mellitus is a metabolic disorder and its subsequent complications such as retinopathy, nephropathy, ulcers, disability, and amputation increase the burden of the disease. Patient knowledge-improving programs are employed to prevent disease progression and to improve the quality of life of the patients. In this way, we need to characterize the groups of patients in urgent need for more and rich-in-content programs. In the present study, we used piecewise regression to evaluate the trends of diabetic nephropathy prevalence in patients registered in the Sedigheh-Tahereh Research Center and to identify patients who were in need of more attention. MATERIALS AND METHODS: Piecewise regression, used in this study, is a statistical method to identify change points, if any, in the trends of mortality rates, prevalence of a disease, or any other trends. Available information for 1,935 patients were retrieved from the database. Joinpoint program 3.5.3 and Statistical Package for the Social Sciences (SPSS) 20 was used to fit piecewise regression and obtain descriptive statistics, respectively. RESULTS: We assessed the trend of diabetic nephropathy in different groups of diabetic patients with respect to sex, blood pressure status, education, family history of diabetes, and age. The results showed an increasing trend in females, patients without family history of diabetes, and eover th recent years. The prevalence of diabetic nephropathy in patients with academic education was high. CONCLUSION: The groups with high prevalence or increasing trends need more preventive intervention and detailed assessment of the present trends. Exploring high-risk groups is beneficial for better policy-making in the future. However, discovering the reasons for the increased trend of the disease is really helpful in controlling diabetes complications.

Effects of calcium-vitamin D co-supplementation on metabolic profiles in vitamin D insufficient people with type 2 diabetes: a randomised controlled clinical trial.

AIMS/HYPOTHESIS: This study was performed to assess the effects of vitamin D and calcium supplementation on the metabolic profiles of vitamin D insufficient persons with type 2 diabetes. METHODS: In a parallel designed randomised placebo-controlled clinical trial, a total of 118 non-smoker individuals with type 2 diabetes and insufficient 25-hydroxyvitamin D, aged >30 years, were recruited from the Isfahan Endocrine and Metabolism Research Centre. Participants were randomly assigned to four groups receiving: (1) 50,000 U/week vitamin D + calcium placebo; (2) 1,000 mg/day calcium + vitamin D placebo; (3) 50,000 U/week vitamin D + 1,000 mg/day calcium; or (4) vitamin D placebo + calcium placebo for 8 weeks. A study technician carried out the random allocations using a random numbers table. All investigators, participants and laboratory technicians were blinded to the random assignments. All participants provided 3 days of dietary records and 3 days of physical activity records throughout the intervention. Blood samples were taken to quantify glycaemic and lipid profiles at study baseline and after 8 weeks of intervention. RESULTS: 30 participants were randomised in each group. During the intervention, one participant from the calcium group and one from the vitamin D group were excluded because of personal problems. Calcium-vitamin D co-supplementation resulted in reduced serum insulin (changes from baseline: -14.8 ± 3.9 pmol/l, p = 0.01), HbA1c [-0.70 ± 0.19% (-8.0 ± 0.4 mmol/mol), p = 0.02], HOMA-IR (-0.46 ± 0.20, p = 0.001), LDL-cholesterol (-10.36 ± 0.10 mmol/l, p = 0.04) and total/HDL-cholesterol levels (-0.91 ± 0.16, p = 0.03) compared with other groups. We found a significant increase in QUICKI (0.025 ± 0.01, p = 0.004), HOMA of beta cell function (HOMA-B; 11.8 ± 12.17, p = 0.001) and HDL-cholesterol (0.46 ± 0.05 mmol/l, p = 0.03) in the calcium-vitamin D group compared with others. CONCLUSIONS/INTERPRETATION: Joint calcium and vitamin D supplementation might improve the glycaemic status and lipid profiles of vitamin D insufficient people with type 2 diabetes. TRIAL REGISTRATION: ClinicalTrials.gov NCT01662193 FUNDING: Clinical Research Council, Isfahan University of Medical Sciences, Isfahan, Iran.

A Hybrid Dynamic Wavelet-Based Modeling Method for Blood Glucose Concentration Prediction in Type 1 Diabetes.

BACKGROUND: Diabetes mellitus (DM) is a chronic disease that affects public health. The prediction of blood glucose concentration (BGC) is essential to improve the therapy of type 1 DM (T1DM). METHODS: Having considered the risk of hyper- and hypo-glycemia, we provide a new hybrid modeling approach for BGC prediction based on a dynamic wavelet neural network (WNN) model, including a heuristic input selection. The proposed models include a hybrid dynamic WNN (HDWNN) and a hybrid dynamic fuzzy WNN (HDFWNN). These wavelet-based networks are designed based on dominant wavelets selected by the genetic algorithm-orthogonal least square method. Furthermore, the HDFWNN model structure is improved using fuzzy rule induction, an important innovation in the fuzzy wavelet modeling. The proposed networks are tested on real data from 12 T1DM patients and also simulated data from 33 virtual patients with an UVa/ Padova simulator, an approved simulator by the US Food and Drug Administration. RESULTS: A comparison study is performed in terms of new glucose-based assessment metrics, such as gFIT, glucose-weighted form of ESODn (gESODn), and glucose-weighted R2 (gR2). For real patients' data, the values of the mentioned indices are accomplished as gFIT = 0.97 ± 0.01, gESODn = 1.18 ± 0.38, and gR2 = 0.88 ± 0.07. HDFWNN, HDWNN and jump NN method showed the prediction error (root mean square error [RMSE]) of 11.23 ± 2.77 mg/dl, 10.79 ± 3.86 mg/dl and 16.45 ± 4.33 mg/dl, respectively. CONCLUSION: Furthermore, the generalized estimating equation and post hoc tests show that proposed models perform better compared with other proposed methods.

Dyslipidaemia and its management in diabetic patients in an academic centre in Iran.

INTRODUCTION: Dyslipidaemia is accompanied with increased cardiovascular events in diabetic patients. Today there have been some improvements in the management of dyslipidaemia using lifestyle modification and medications. In this study we evaluate the management of dyslipidaemia in an academic centre. MATERIAL AND METHODS: This is a descriptive study, from January 2003 until December 2007. All type 2 diabetic patients who were more than 30 years old and had at least 2 visits per year were eligible for including. RESULTS: Overall, 1179 patients (70.2% women) were assessed. Mean LDL-C in 2003 was 124.6 +/- 34.6 mg/dL, and decreased to 109.7 +/- 28.9 mg/dL in 2007 (p < 0.05). 21.0% of patients in 2003 and 40.5% of them in 2007 had LDL-C < 100 mg/dL. TG did not change during these years. There was an increase in the use of statins from 76.3% to 84.3% (p-value < 0.05) during the 5 years since 2003, but a decrease in the use of fibrates. CONCLUSIONS: Although recently we have made improvements in the control of dyslipidaemia in diabetic patients, we have not reached our goals. Of late, physicians have emphasized the use of statins in diabetic patients, which has resulted in much better levels of LDL-C, but still less than half of the patients are at ideal levels. In conclusion, we should revise our point of view to begin and intensify treatment of dyslipidaemia in diabetic patients, to achieve the goal of treatment and prevent cardiovascular events optimally.

Nonalcoholic fatty liver disease: Diagnostic biomarkers.

Nonalcoholic fatty liver disease is a common medical condition worldwide and its prevalence has increased notably in the past few years due to the increases in prevalence of obesity and metabolic syndrome. However, diagnosis of this disease is still a matter of debate because of disease variations and pathophysiologic alterations. Specific single markers have gained considerable attention recently, among them markers related to hepatic pathophysiology, inflammation, adipocytokines and so forth. But, it seems that no single marker is sufficient for diagnosis and staging of the disease, and applying a panel including different types of tests may be more useful.

The TSH levels and risk of hypothyroidism: Results from a population based prospective cohort study in an Iranian adult's population.

OBJECTIVE: The aim of current study was to assess the relationship between serum TSH levels and hypothyroidism risk in the euthyroid population. METHODS: In a population-based cohort study, a total of 615 individuals with a normal baseline TSH, from of total population (n=2254) in 2006, were followed up for 6years. TSH, total T4, thyroid peroxidase antibody (TPOAb), and thyroglobulin antibody (TgAb) were measured. The relative risk (RR) and 95% confidence interval (95%CI) were calculated based on logistic regression. The Receiver Operating Characteristic (ROC) analysis along with area under the curve (AUC) was used to prediction of future hypothyroidism. RESULTS: TSH level in 2006 was a significant predictor for overt hypothyroidism, in the total population (RR=3.5) and female (RR=1.37) (all, P value<0.05). A cutoff value of TSH at 2.05mIU/L [AUC: (CI95 %), 0.68 (0.44-0.92; P=0.05)] was obtained for differentiating the patients with overt hypothyroidism from euthyroid. However, this cut off was not observed when we included only negative TPO and TgAbs people in 2006. The RR of hypothyroidism increased gradually when TSH level increased from 2.06-3.6mIU/L to >3.6mIU/L in the total population and both sexes. In women, the risk of overt hypothyroidism was significantly higher in subjects with TSH above 3.6 than those subject with THS levels≤2.05 [RR: (CI95 %), 20.57(2.-207.04), P value<0.05]. CONCLUSION: A cutoff value of TSH at 2.05mIU/L could predict the development of overt hypothyroidism in future. However, it was not applicable for people with negative TPOAb and negative TgAb.

Factors Associated With Serum Albumin in Diabetes Mellitus Type 2 With Microalbuminuria Using Non-Normal Mixed Models: A Prospective Cohort Study.

BACKGROUND: The globally increasing epidemic of diabetes will lead to serious problems including diabetic nephropathy and kidney diseases in near future. The first clinical diagnosable stage in a diabetic kidney disease is microalbuminuria (urinary albumin excretion of 30 - 300 g/24 hours). OBJECTIVES: This prospective cohort study investigated the risk factors of microalbuminuria in patients with type 2 diabetes who had been registered in endocrine and metabolism research center in Isfahan city, Iran. PATIENTS AND METHODS: This prospective cohort study was performed on 90 diabetic type 2 patients with microalbuminuria, who were selected according to the consecutive sample selection method during 6 years. Data were collected through regular and systematic measurements of serum albumin as the response variable and body mass index, systolic and diastolic blood pressure, the duration of diabetes, glycosylated hemoglobin (HbA1c), total cholesterol, triglyceride (TG), fasting blood sugar (FBS), low-density lipoprotein (LDL), and high-density lipoprotein (HDL) as the related factors. Non-normal mixed models were used to investigate the impact of effective factors on the amount of excreted serum albumin. RESULTS: According to the deviance information criterion (DIC = 56.2), the non-normal mixed effects model with the skewed t distribution had a best fit and indicated that HbA1c, HDL and total cholesterol had a significant effect on the amount of albumin in urine (P < 0.05). CONCLUSIONS: Using nonnormal mixed models may lead to the best results as compared to common normality assumption.

Predictors of all-cause and cardiovascular-specific mortality in type 2 diabetes: A competing risk modeling of an Iranian population.

BACKGROUND: In Asian population, diabetes mellitus is increasing and has become an important health problem in recent decades. In Iran, cardiovascular disease (CVD) accounts for nearly 46% of the total costs spent for diabetes-associated diseases. Because individuals with diabetes have highly increased CVD risk compared with normal individuals, it is important to diagnosis factors that may increase CVD risk in diabetic patients. The study objective was to identify predictors associated with CVD mortality in patients with type 2 diabetes (T2D) and to develop a prediction model for cardiovascular (CV)-death using a competing risk approach. MATERIALS AND METHODS: The study population consisted of 2638 T2D (male = 1110, female = 1528) patients aged ≥35 years attending from Endocrine and Metabolism Research Center in Isfahan for a mean follow-up period of 12 years; predictors for different cause of death were evaluated using cause specific Cox proportional and subdistribution hazards models. RESULTS: Based on competing modeling, the increase in blood pressure (BP) (spontaneously hypertensive rats [SHR]: 1.64), cholesterol (SHR: 1.55), and duration of diabetes (SHR: 2.03) were associated with CVD-death. Also, the increase in BP (SHR: 1.85), fasting blood sugar (SHR: 2.94), and duration of diabetes (SHR: 1.68) were associated with other death (consist of cerebrovascular accidents, cancer, infection, and diabetic nephropathy). CONCLUSIONS: This finding suggests that more attention should be paid to the management of CV risk in type 2 diabetic patients with high cholesterol, high BP, and long diabetes duration.

Effects of Pomegranate Seed Oil on Metabolic State of Patients with Type 2 Diabetes Mellitus.

BACKGROUND: Rapid increasing prevalence of diabetes mellitus is a serious health concern in the world. New data determined that the pathogenesis of diabetes mellitus is chronic low-grade inflammation, resulting insulin resistance. Pomegranate seed oil (PSO) has anti-inflammatory effects; though it may reduce insulin resistance and improve glycemia in diabetes mellitus. The present study has been designed to investigate the effects of PSO as a natural dietary component on metabolic state of patients with Type 2 diabetes mellitus. METHODS: In a randomized double-blind clinical trial study, 80 patients (28 men) with Type 2 diabetes were randomly allocated to the intervention and control groups. The intervention group consumed PSO capsules, containing 1000 mg PSO twice daily (2000 mg PSO), whereas controls take placebo for 8 weeks. The participants followed their previous dietary patterns and medication use. Dietary factors and metabolic factors including lipid profile, fasting plasma sugar, and insulin and were assayed at the baseline and after 8 weeks. RESULTS: Participants in two intervention and control group were similar regarding anthropometric and the dietary factors at baseline and after trial (P > 0.05). Mean level of total cholesterol, triglyceride, low-density lipoprotein-cholesterol, and high-density lipoprotein was not different significantly between groups after trial (P > 0.05). Consumption of PSO did not significantly affect the levels of parameters such as fasting blood sugar (FBS), insulin, HbA1c, alanine transferase, and homeostasis model assessment-insulin resistance. CONCLUSIONS: Consumption of 2000mg PSO per day for 8 weeks had no effect on FBS, insulin resistance and lipid profile in diabetic patients.

Stability of Vitamin D3 in fortified yoghurt and yoghurt drink (Doogh).

BACKGROUND: Vitamin D deficiency and insufficiency are recognized as a worldwide problem with serious consequences. Fortification of foods with Vitamin D is a certain approach to improve serum Vitamin D status if the stability of vitamin in the foodstuffs was controlled. The purpose of this study was to examine the stability of Vitamin D3 added to low-fat yogurt and yogurt drink "Doogh" during the products shelf-life. MATERIALS AND METHODS: Two kinds of Vitamin D3, water- and oil-dispersible forms, suitable for food fortification, were compared to find out whether they show different stability in the products. The products were packed in opaque or translucent containers. The content of Vitamin D3 was determined by high performance liquid chromatography method. RESULTS: Vitamin D was not affected by the heat treatment (pasteurization) and other processes (homogenization and fermentation). Both water- and oil-dispersible forms were stable during the shelf-life of yogurt samples packed in opaque containers. The Vitamin D3 content of yogurt fortified with water-dispersible form and packed in translucent containers was not stable during the shelf-life and significantly reduced after 1, 2, and 3 weeks of storage compared to the day 0. The Vitamin D3 content of samples fortified with the oil-dispersible form packed in the same container was only stable after 1-week and significantly reduced after 2 and 3 weeks of storage. The Vitamin D3 content of Doogh packed in the opaque containers remained stable during the shelf-life while it was not stable in the samples packed in translucent containers. CONCLUSION: The results suggested that both forms of Vitamin D are suitable for fortification, and opaque container is a better choice for packaging of the product.

Effects of vitamin D-fortified low fat yogurt on glycemic status, anthropometric indexes, inflammation, and bone turnover in diabetic postmenopausal women: A randomised controlled clinical trial.

BACKGROUND & AIMS: Low levels of serum 25-hydroxy vitamin D (25(OH)D) are common in type 2 diabetic patients and cause several complications particularly, in postmenopausal women due to their senile and physiological conditions. This study aimed to assess the effects of vitamin D-fortified low fat yogurt on glycemic status, anthropometric indexes, inflammation, and bone turnover in diabetic postmenopausal women. METHODS: In a randomized, placebo-controlled, double-blind parallel-group clinical trial, 59 postmenopausal women with type 2 diabetes received fortified yogurt (FY; 2000 IU vitamin D in 100 g/day) or plain yogurt (PY) for 12 weeks. Glycemic markers, anthropometric indexes, inflammatory, and bone turnover markers were assessed at baseline and after 12 weeks. RESULTS: After intervention, in FY group (vs PY group), were observed: significant increase in serum 25(OH)D and decrease of PTH (stable values in PY); significant improvement in serum fasting insulin, HOMA-IR, HOMA-B, QUICKI, and no changes in serum fasting glucose and HbA1c (significant worsening of all indexes in PY); significant improvement in WC, WHR, FM, and no change in weight and BMI (stable values in PY); significant increase of omentin (stable in PY) and decrease of sNTX (significant increase in PY). Final values of glycemic markers (except HbA1c), omentin, and bone turnover markers significantly improved in FY group compared to PY group. Regarding final values of serum 25(OH)D in FY group, subjects were classified in insufficient and sufficient categories. Glycemic status improved more significantly in the insufficient rather than sufficient category; whereas the other parameters had more amelioration in the sufficient category. CONCLUSIONS: Daily consumption of 2000 IU vitamin D-fortified yogurt for 12 weeks improved glycemic markers (except HbA1c), anthropometric indexes, inflammation, and bone turnover markers in postmenopausal women with type 2 diabetes. TRIAL REGISTRATION: www.irct.ir (IRCT2013110515294N1).

The Effect of Purslane Seeds on Biomarkers of Oxidative Stress in Diabetic Patients: A Randomized Controlled Cross-over Clinical Trial.

BACKGROUND: This study was designed to examine the effects of purslane seeds on biomarkers of oxidative stress in type 2 diabetic patients. METHODS: This cross-over randomized controlled clinical trial was conducted on 40 patients with type 2 diabetes. Participants were randomly assigned to receive either 10 g/day purslane seeds with 240 cc low-fat yogurt (intervention group) or only 240 cc low-fat yogurt (as a control group) for 5 weeks. After a 2-week washout period, subjects were moved to the alternate arm for an additional 5 weeks. At baseline and end of each study phase, fasting blood samples were collected to quantify biomarkers of oxidative stress. RESULTS: We observed a slight decrease in plasma total antioxidant capacity in both groups, however, between-group changes were not significant (-2.67 vs. -2.95 µg/dL, P = 0.94). Plasma malondialdehyde in purslane group increased slightly, however, we observed no significant effect in the control group (1.62 vs. -0.47 µg/dL, P = 0.58). Although both groups had a slight reduction in plasma oxidized low-density lipoprotein (ox-LDL), we failed to find any significant effect of purslane on plasma ox-LDL (-1.06 vs. -1.71 µg/dL, P = 0.85). CONCLUSIONS: This cross-over clinical trial revealed that consumption of purslane seeds for 5 weeks in type 2 diabetic patients did not result in improved oxidative stress.

Effect of non-soy legume consumption on inflammation and serum adiponectin levels among first-degree relatives of patients with diabetes: a randomized, crossover study.

OBJECTIVE: First-degree relatives of patients with diabetes are at more risk for endothelial dysfunction and inflammation. The aim of the present study was to determine the effects of a non-soy legume-enriched diet on inflammatory biomarkers and serum adiponectin levels among first-degree relatives of these patients. METHODS: Twenty-six participants (14 women and 12 men) with a family history of diabetes were recruited to this randomized, crossover study. Participants were randomly assigned to a legume-enriched or a habitual diet for 6 wk that was separated by a 2-wk washout. The inflammatory markers-high-sensitivity C-reactive protein (hs-CRP), interleukin-6, tumor necrosis factor-α, and serum levels of adiponectin-were measured at the beginning and the end of each intervention period according to the standard protocol. RESULTS: Energy intake of participants was not statistically different between the two diets (1821.5 ± 100.11 versus 1788.2 ± 92.68 kcal/d, respectively). After consumption of a legume diet, percent change of hs-CRP reduced significantly compared with consumption of a habitual diet (-4.86% ± 1.86% versus 3.55% ± 1.97%, P = 0.002) and among the women in the study (-12.96% ± 1.96% versus 3.24% ± 2.65%, P = 0.004). The percent change of other inflammatory markers and serum concentrations of adiponectin were not significantly different between the two diet groups. CONCLUSION: The results of this study showed that a legume-enriched diet significantly reduced the hs-CRP concentrations in first-degree relatives of patients with diabetes after 6 wk of intervention compared with a habitual diet.

Evaluation of peripheral arterial disease in prediabetes.

BACKGROUND: The prevalence of prediabetes in the world continues to increase. These patients have elevated the risk of atherosclerosis. The current study was designed to assess the prevalence of peripheral arterial disease (PAD) and its related risk factors in prediabetes patients. METHODS: This was the case-control study in which 135 adults in three groups: Diabetes, prediabetes, and normal were studied. We evaluated the prevalence of PAD through the measurement of ankle-brachial index (ABI). All the patients were interviewed about demographic and medical data, including age, sex, disease duration, body mass index, hypertension (HTN), fasting blood glucose, hemoglobin A1C (HbA1C), lipid profile, and medication use. RESULTS: The prevalence of PAD in diabetes patients was higher than the normal group (8.5%vs. 0.0%) (P < 0.05), but the differences between prediabetes compared with diabetes and normal group were not significant. The mean level of ABI in normal, prediabetes, and diabetes group was (1.11 ± 0.11), (1.09 ± 0.12), and (1.05 ± 0.03) respectively (P < 0.1). There were marginally significant differences of ABI observed between the normal group and the diabetes group. The observed differences between groups in the ABI were significant after adjusting the effects of age and sex (P < 0.05). There was an association observed between ABI and HbA1C in diabetes patients (r = 0.249, P < 0.01) and a significant association seen between PAD and HTN in the prediabetes group (P < 0.01). CONCLUSIONS: Peripheral arterial disease is common in asymptomatic diabetes and prediabetes patients. Management of hypertensive prediabetes patients and early detection of PAD in this group as well as in asymptomatic patients is important.

Predicting of trend of hemoglobin a1c in type 2 diabetes: a longitudinal linear mixed model.

BACKGROUND: There are some evidences that control the blood sugar decreasing the risk of diabetes complications, and even fatal. There are so many studies, but they are mostly cross-sectional and ignore the trend and hence it is necessary to implement a longitudinal study. The aim of this prospective study is to find the trend of glycosylated hemoglobin (HbA1c) over time and the associative factors on it. METHODS: Participants of this longitudinal study were 3440 eligible diabetes patients referred to Isfahan Endocrine and Metabolism Research Center during 2000-2012 who are measured 2-40 times. A linear mixed model was applied to determine the association between HbA1c and variables, including lipids, systolic, diastolic blood pressure and complications such as nephropathy, and retinopathy. Furthermore, the effect of mentioned variables on trend of HbA1c was determined. RESULTS: The fitted model showed total cholesterol, retinopathy, and the method of therapy including oral antidiabetic drugs (OADs) plus insulin and insulin therapy decreased the trend of HbA1c and high-density lipoprotein, weight, hyperlipidemia and the method of therapy including diet, and OADs increased the trend of HbA1c. CONCLUSIONS: The present study shows that regular visits of diabetic patients as well as controlling blood pressure, lipid profile, and weight loss can improve the trend of HbA1c levels during the time.

Calcium-vitamin D cosupplementation influences circulating inflammatory biomarkers and adipocytokines in vitamin D-insufficient diabetics: a randomized controlled clinical trial.

CONTEXT: To the best of our knowledge, no study has examined the effects of vitamin D-calcium cosupplementation on inflammatory biomarkers and adipocytokines in vitamin D-insufficient type 2 diabetics. OBJECTIVE: This study was performed to assess the effects of vitamin D and calcium supplementation on inflammatory biomarkers and adipocytokines in vitamin D-insufficient people with type 2 diabetes. METHODS: Totally, 118 diabetic patients were enrolled in this randomized, placebo-controlled clinical trial. After matching for age, sex, body mass index, type and dose of hypoglycemic agents, and duration of diabetes, subjects were randomly assigned into 4 groups receiving the following: 1) 50000 IU/wk vitamin D + calcium placebo; 2) 1000 mg/d calcium + vitamin D placebo; 3) 50 000 IU/wk vitamin D + 1000 mg/d calcium; or 4) vitamin D placebo + calcium placebo for 8 weeks. Blood sampling was done for the quantification of inflammatory biomarkers and adipocytokines at the study baseline and after 8 weeks of intervention. RESULTS: Calcium (changes from baseline: -75 ± 19 ng/ml, P = .01) and vitamin D alone (-56 ± 19 ng/mL, P = .01) and joint calcium-vitamin D supplementation (-92 ± 19 ng/mL, P = .01) resulted in a significant reduction in serum leptin levels compared with placebo (-9 ± 18 ng/mL). This was also the case for serum IL-6, such that calcium (-2 ± 1 pg/mL, P < .001) and vitamin D alone (-4 ± 1 pg/mL, P < .001) and their combination (-4 ± 1 pg/mL, P < .001) led to significant reductions compared with placebo (3 ± 1 pg/mL). After adjustment for potential confounders, individuals in the calcium (-3.1 ± 1.3, P < .05), vitamin D (-3.1 ± 1.3, P < .05), and joint calcium-vitamin D groups (-3.4 ± 1.3, P < .05) had greater reductions in serum TNF-α concentrations compared with placebo (0.1 ± 1.2). Individuals who received joint calcium-vitamin D supplements tended to have a decrease in serum high-sensitivity C-reactive protein levels compared with placebo after controlling for baseline levels (-1.14 ± 0.25 vs 0.02 ± 0.24 ng/mL, P = .09). CONCLUSION: Joint calcium-vitamin D supplementation might improve systemic inflammation through decreasing IL-6 and TNF-α concentrations in vitamin D-insufficient people with type 2 diabetes.