Appetite sensation improvement by synbiotic supplementation in patients with metabolic syndrome: A randomized controlled clinical trial.

The potential link between dysbiosis, features of metabolic syndrome (MetS), inflammation, and sensation impairment has been recently recognized. However, in this context, there are few indications available regarding the effects of co-supplementation with Bacillus indicus, Bacillus coagulans, and fructooligosaccharide (FOS) prebiotics on patients with MetS. Therefore, this study aimed to investigate the effects of synbiotic supplementation on glycemic indices, inflammatory biomarkers, and appetite among adults with MetS. This study is a randomized, double-blind, placebo-controlled clinical trial conducted in the Endocrine and Metabolism Research Center outpatient clinic in Isfahan, Iran. Fifty-eight MetS patients were randomly assigned to receive either synbiotics (n = 29) or placebo (n = 29) supplementation twice per day for 8 weeks. Finally, 55 patients were recruited for analyses (28 in the intervention group and 27 in the placebo group). Random permuted blocks and a computer-generated random number table were used for treatment allocation. No adverse effects were reported during the study. There were no significant differences in glycemic indices and inflammatory markers within- and between groups (all p > .05). However, a significant increase in the sensation of fullness was documented in the synbiotic group. In conclusion, the eight-week treatment did not improve glycemic control and inflammatory markers. Nevertheless, it demonstrated potential efficacy in enhancing participants' appetite sensations, warranting further evaluation in longer intervention periods during future clinical trials.

Associations between empirically derived dietary patterns and oxidative stress and inflammation in adults with primary hypothyroidism: a case-control study.

BACKGROUND: Primary hypothyroidism is a common endocrine disorder caused by impaired production of thyroid hormones. Recent studies have shown that dietary habits, oxidative stress, and inflammation may play roles in thyroid hypofunction. Thus, the present article aimed to determine the relationship between major dietary patterns and oxidative stress and inflammation in primary hypothyroid patients and healthy people in Iranian adults. METHODS: This matched case-control study was conducted on 200 participants (100 cases and 100 controls). The presence of primary hypothyroidism was determined by endocrinologists based on American Thyroid Association (ATA) criteria. Dietary intake was assessed using a validated 168-item, semi-quantitative food frequency questionnaire (FFQ). The principal component analysis (PCA) method was used to derive major dietary patterns. Statistical analysis was performed using logistic regression analysis, and the findings were reported using odds ratios (ORs) with 95% CIs. RESULTS: We identified 2 major dietary patterns (i.e., healthy and Western dietary patterns). After adjusting for confounding variables, participants in the highest tertile of the healthy eating pattern had lower odds of primary hypothyroidism. Also, there was a significant relationship between total antioxidant capacity (TAC) levels and thyroid hypofunction; however, no significant correlation was seen between the Western dietary pattern and malondialdehyde (MDA) and C-reactive protein (CRP) with hypothyroidism. CONCLUSIONS: There were statistically direct associations between healthy dietary patterns (loaded with vegetables, nuts and seeds, fruits, dried fruits, olives, garlic, black pepper, starchy vegetables, low-fat dairy, and legumes) and increased TAC levels with a decreased risk of thyroid hypofunction. However, Western dietary patterns and MDA and CRP levels did not associate with an underactive thyroid.

The effect of linagliptin on microalbuminuria in patients with diabetic nephropathy: a randomized, double blinded clinical trial.

The aim of the present study was to investigate the effect of linagliptin on microalbuminuria in patients with diabetic nephropathy (DN). The present double-blind randomized placebo-controlled clinical trial was performed on 92 patients with DN who were divided into two groups. The intervention and control groups received linagliptin 5 mg and placebo for 24 weeks, respectively. Blood pressure, lipid profile, liver enzymes, fasting plasma glucose (FPG), and urine albumin-creatinine ratio (UACR) were assessed and recorded before, 12 weeks, and 24 weeks after the beginning of the intervention. The mean value of UACR decrease was significant over time in both groups, with higher decrease in linagliptin group, however, the differences between two groups were not, statistically significant (P > 0.05). However, the percentage of improvement in microalbuminuria (UACR < 30 mg/g) in the linagliptin group was significantly higher than that of the control group during 24 weeks of intervention (68.3% vs. 25%; P-value < 0.001). There was no statistically significant difference in the mean value of the UACR and other parameters between linagliptin treated and placebo treated patients with diabetic nephropathy. Further studies, with longer periods of follow-up are suggested to examine these patients' renal outcomes.

Effect of bread fortification with pomegranate peel powder on glycemic indicators, antioxidant status, inflammation and mood in patients with type 2 diabetes: study protocol for a randomized, triple-blind, and placebo-controlled trial.

Background: The oxidative stress caused by the creation and breakdown of reactive oxygen species affects glucose tolerance, B-cell function, insulin resistance, and metabolites containing free fatty acids. Functioning foods are therefore becoming increasingly popular because they provide health benefits and prevent oxidative stress. This research aims to assess strategies to alleviate oxidative stress and inflammation in patients with type 2 diabetes (T2DM). In the present study, the metabolic effect wheat bread fortified with pomegranate peel powder(PPP) will be assessed in participants with type 2 diabetes. Methods: A randomized, triple-blind, placebo-controlled, and parallel arms clinical trial will be conducted on 90 patients with T2DM. Run-in courses will last for two weeks. The intervention and control groups will receive wheat bread with and without PPP, respectively. Anthropometric data, fasting plasma glucose, hemoglobin A1C, lipid profile, insulin level, high-sensitivity C-reactive protein (hs-CRP), malondialdehyde (MDA), Total antioxidant capacity(TAC), and mood state, will be measured at the baseline and three months post-intervention. Beta-cell function (HOMA-B) and insulin resistance (HOMA-IR) will also be assessed. Discussion: This trial will provide novel data on the impact of fortified bread with PPP on metabolic profile and mood state of patients with type 2 diabetes. The results will demonstrate the potential of such intervention in glycemic indices, antioxidant status, inflammation and mood in these patients. Trial Registration: Trial is registered in the Iranian Registry of Clinical Trials (ID: IRCT20191209045672N1). Date of registration 21/09/2020. https://en.irct.ir/trial/48132.

Successful Stem Cell Mobilization and CD34+ Cell Collection in a Poor Mobilizer: A Case Report Utilizing a Combination of Recombinant Growth Colony Stimulating Factor, Recombinant Human Growth Factor, and Plerixafor.

Diffuse large B-cell lymphoma is the most prevalent form of non-Hodgkin's lymphoma that is usually treated with chemoimmunotherapy. If the disease proves refractory or recurrent, the primary treatment approach involves high-dose chemotherapy with bone marrow transplantation. The collection of peripheral blood stem cells before transplantation plays a vital role in the treatment process, necessitating the mobilization of blood stem cells from the bone marrow to the peripheral blood. Despite using standard methods such as granulocyte colony-stimulating factor (G-CSF), chemotherapy, and plerixafor, some patients cannot collect an optimal count of CD34+ cells for transplantation. Managing these patients with poor mobilization poses significant challenges. In this article, we present a case of a poor mobilizer patient who achieved prosperous mobilization by using recombinant human G-CSF, recombinant human growth hormone, and plerixafor.

The effects of wheat germ consumption on mental health and brain-derived neurotrophic factor in subjects with type 2 diabetes mellitus: a randomized, double-blind, placebo-controlled trial.

Objectives: Herbals, as bioactive foods, have been one of the most popular alternatives and complementary treatments in preventing and controlling type 2 diabetes mellitus (T2DM). The aim of the present trial was to examine the effects of wheat germ consumption on mental health and brain-derived neurotrophic factor (BDNF) among patients with T2DM.Methods: Eighty participants with T2DM were randomly allocated to receive 20 g wheat germ (n = 40) or placebo (n = 40) in a randomized double-blind clinical trial for 12 weeks. Depression, anxiety, stress scale-21 (DASS-21) questionnaire was used to assess the mental health of study participants. Serum BDNF was assessed at the baseline and end of intervention. Anthropometric indices were measured at the baseline, 6 and 12 weeks during the intervention.Results: A total of 75 subjects completed the trial. Compared with the placebo, wheat germ consumption led to a significant reduction in depression (P = .03) and stress (P = .04) scores. Moreover, a significant increase in serum BDNF concentrations was observed in the wheat germ group (P = .004), while there was no significant difference between the groups. Wheat germ intake had no significant effects on anthropometric indices and anxiety scores between the groups.Conclusion: Our findings showed that wheat germ consumption for 12 weeks could significantly reduce the stress and depression scores but had no significant effects on anxiety scale and anthropometric outcomes in patients with T2DM.

Isfahan Thyroid Cohort Study (ITCS).

BACKGROUND: The Isfahan Thyroid Cohort Study (ITCS) is one of the few population-based epidemiological studies in Iran that investigates the prevalence and incidence of thyroid disorders including hypothyroidism, hyperthyroidism, goiter, nodule, and iodine status. METHODS: This cohort is located in Isfahan, Iran. The first phase was initiated in 2006 with 2523 participants (1275 males, 1248 females). The participants were selected using multi-stage cluster sampling from the general residents of Isfahan, Iran. The study had two phases (2006 and 2011) and its third stage is planned for 2020-2021. RESULTS: The prevalence of thyroid function states was euthyroid (89.3%, 95% CI: 88%-90%), overt hypothyroidism (2.8%, 95% CI: 2%‒3%), subclinical hypothyroidism (5.8%, 95% CI: 4%-6%), overt hyperthyroidism (0.8%, 95% CI: 0.4%‒1%), and subclinical hyperthyroidism (0.99%, 95% CI: 0.6%-1%). Hypothyroidism and hyperthyroidism were significantly associated with goiter. The incidence of thyroid dysfunction was reported as follows: overt hypothyroidism (2.7, 95% CI: 1.6-3.7), subclinical hypothyroidism (20.6, 95% CI: 18-23), overt hyperthyroidism (1.9, 95% CI: 1-2.7) and subclinical hyperthyroidism (2.7, 95% CI: 1.6-3.7) per 1000 (person-year). CONCLUSION: We assessed the prevalence and incidence of thyroid disorders in Isfahan in the first and second phase, respectively. We are conducting the third phase of the ITCS in order to study the associations between thyroid peroxidase antibody (TPOAb) level and environmental factors such as infection.

Ultrasound-guided ethanol injection for the treatment of parathyroid adenoma: A prospective self-controlled study.

BACKGROUND: Parathyroidectomy, the standard treatment of primary hyperparathyroidism (PHP) due to parathyroid adenoma, is not suitable for all patients. We evaluated the efficacy of ultrasound-guided ethanol ablation of parathyroid adenoma in a group of patients with PHP. MATERIALS AND METHODS: In a prospective self-controlled trial, 39 patients with parathyroid adenoma, who were not candidates for surgery, were enrolled. Ethanol injections were performed by two experienced interventional radiologists under the guidance of real-time ultrasonography. Adenoma size changes were assessed at about 1 month later. Serum levels of parathyroid hormone, calcium, phosphate, 25-OH Vitamin D, and alkaline phosphatase were evaluated at the baseline, 1, 3, 6, and 12 months after the injections. The treatment effects on outcome variables were assessed by repeated measures analysis. RESULTS: Volume of the adenomas decreased during the study period from 1.87±6.45 cm3 to 0.38± 0.48cm3 (P < 0.001). Corrected serum calcium levels decreased from 10.40 ± 0.96 mg/dl to 8.82 ± 0.58 mg/dl (P < 0.001), and remained stable during one year follow-up. Serum levels of parathyroid hormone decreased gradually from 129.85 ± 63.37 to 72.58 ± 53.86 pg/mL after 3 months and to 44.78 ± 28.04 pg/mL after 1 year (P < 0.001). Overall, 46% of the patients improved after 1 month of ethanol ablation therapy which increased to 84.5% during 1-year follow-up. No major complications were observed. CONCLUSION: The current study showed the efficacy of ultrasound-guided ethanol injection in PHP and may be considered as a suitable alternative treatment in patients who are not candidates for the surgery. It has also a good safety profile without major complications if performed by experienced hands.

The effect of synbiotic supplementation on anthropometric indices, appetite, and constipation in people with hypothyroidism: A randomized, double-blind, placebo-controlled trial.

Hypothyroidism and obesity are two highly prevalent conditions that appear to be closely related. Hypothyroidism is correlated with weight gain, loss of appetite, constipation, and a higher incidence of obesity. The present study aimed to investigate the effects of synbiotic supplementation on anthropometric indices, appetite, and constipation in subjects with hypothyroidism. Sixty subjects with hypothyroidism were assigned into two groups to receive either 500 mg/day of synbiotic (n = 30) or a placebo (n = 30) per day for 8 weeks. Anthropometric indices, appetite, and constipation were assessed at study baseline and end of the trial. At the end of trial, waist-to-hip ratio was significantly decreased in the synbiotic group (p = .030), whereas there were no significant differences between groups. We did not observe any statistically significant change in appetite or other anthropometric indices (p > .05). Compared with the placebo synbiotic supplementation led to a significant reduction in constipation (p = .048). The results of the present trial indicated that synbiotic supplementation may have favorable results in constipation among subjects with hypothyroidism for 8 weeks. Further studies with larger sample size and longer duration are needed to confirm our findings.

The effects of synbiotic supplementation on thyroid function and inflammation in hypothyroid patients: A randomized, double­blind, placebo­controlled trial.

BACKGROUND: There is a positive link between thyroid homeostasis and the composition of gut microbiota. A limited number of studies have suggested the efficacy of probiotic products on levothyroxine metabolism and thyroid hormone activity. Therefore, the purpose of this study was to investigate the effect of synbiotic supplementation on thyroid function, inflammation markers, and blood pressure in subjects with hypothyroidism. METHODS: This study was conducted as a randomized, double-blind, placebo-controlled trial involving 60 patients with hypothyroidism. Participants were randomly recruited into two groups to receive either 500 mg/day of synbiotic (n = 30) or a placebo (n = 30) for 8 weeks. RESULTS: Thyroid-stimulating hormone concentration, levothyroxine dose, and fatigue severity scale score were significantly decreased after the 8-week intervention in the synbiotic group (P < 0.05), while there were no significant differences seen in the placebo group. In addition, FT3 at the end of intervention was significantly higher (P = 0.001) in both groups, although these changes were not significant between the two groups (P = 0.259). Synbiotic supplements led to a significant elevation in serum CRP (P = 0.006), but this increase was not significant between groups (P = 0.699). Moreover, no statistical significance was observed within or between groups in terms of anti-thyroid peroxidase, systolic blood pressure and diastolic blood pressure (P > 0.05). CONCLUSION: Synbiotic supplementation among hypothyroid patients for 8 weeks may have beneficial effects on thyroid function. Further studies with larger sample size and longer duration are needed to confirm the current findings.

The effects of wheat germ supplementation on metabolic profile in patients with type 2 diabetes mellitus: A randomized, double-blind, placebo-controlled trial.

The aim of the present trial was to examine the effects of wheat germ (WG) consumption on metabolic control and oxidative stress status of type 2 diabetes mellitus (T2DM) patients. Eighty participants with T2DM were randomly allocated to receive 20-g WG (n = 40) or placebo (n = 40) in a randomized double-blind clinical trial for 12 weeks. Serum lipid profiles, glycaemic indices, total antioxidant capacity, and malondialdhyde (MDA) were assessed. A total of 75 subjects completed the trial. Compared with the placebo, WG consumption led to significant reduction in total cholesterol (TC) concentrations (p = .04). There was a trend regarding TC to high density lipoprotein ratio (p = .08) following 12 weeks WG consumption, although they were not statistically significant after correcting for multiple testing. In addition, within-group comparison revealed a significant rise in total antioxidant capacity concentration (p = .001) in WG group. We observed no significant effects of WG intake on glycaemic status, blood pressure, MDA, triglyceride, and low density lipoprotein levels. WG consumption for 12 weeks could decrease serum TC levels and had no significant effects on other metabolic variables and MDA in patients with T2DM. Though observed health benefit effects were small, it might lead to a major impact on wider public health.

A Case of Functional Metastatic Follicular Thyroid Carcinoma that Presented with Hip Fracture and Hypercalcemia.

Thyroid follicular cancers are one of the thyroid gland cancers. This cancer can lead to metastases to various areas of the body. We describe a patient with thyroid follicular carcinoma who after total thyroidectomy had severe hypercalcemia, increased creatinine, and thyrotoxicosis due to extensive bone metastases. The patient was a 52-year-old man who had femoral neck fracture as the first manifestation of thyroid cancer. He was hospitalized for some time after orthopedic measures because of thyrotoxicosis and deep-venous thrombosis. The study found that the origin of metastatic lesions was thyroid follicular cancer, leading to extensive bone metastases. After administering of methimazole and control of thyrotoxicosis, he was subjected to total thyroidectomy. Methimazole was discontinued immediately after surgery. One month after surgery, ultrasound confirmed that the thyroid was completely removed. However, T3 (triiodothyronine) remained high; besides the patient had hypercalcemia and increased creatinine due to dehydration. The patient was retreated with methimazole due to thyrotoxicosis, and for hypercalcemia fluid therapy, intravenous zoledronic acid was prescribed. These measures led to the normalization of creatinine and glomerular filtration rate. The purpose of introducing this case report was that these symptoms are a rare manifestation of functional metastases of follicular thyroid carcinoma after total thyroidectomy. Bone metastases of follicular thyroid carcinoma may be functional and are lytic that can lead to hypercalcemia and its complications.

The effects of conventional drugs in the treatment of rheumatoid arthritis on the serum lipids.

BACKGROUND: Rheumatoid arthritis (RA) is a common chronic autoimmune disorder that leads to damage of human joints. There are various treatment approaches in which different drugs are prescribed which have several alterations in serum lipids. This research aimed to study the effect of RA treatments on the serum lipids. MATERIALS AND METHODS: Two hundred randomly selected patients with RA were randomly assigned to three different groups. The first group of patients was treated with a combination of prednisolone (PRD) and hydroxychloroquine (HCQ). The second group was treated with three drugs including PRD, HCQ, and methotrexate (MTX). The third group was treated with four medications including PRD, HCQ, MTX, and sulfasalazine. Within each group, the lipid factors such as triglyceride (TG), total cholesterol (TC), low-density lipoprotein (LDL), and high-density lipoprotein (HDL), erythrocyte sedimentation rate, and visual analog scale were measured at the beginning of the experiment and 6 months after exposing the treatments. For each group, we also calculated the Disease Activity Score-28 (DAS-28). The analysis of variance revealed that the overall DAS-28 was significantly different among the three groups. RESULTS: In the first group, the level of TG and TC significantly decreased (P = 0.015 and P ≤ 0.001, respectively). In the second group, the level of TG and LDL significantly decreased (P = 0.009). In the third group, the LDL level increased considerably (P < 0.001). The HDL level significantly increased in all three groups (P = 0.012, P = 0.014, and P = 0.028, respectively). CONCLUSION: The treatment PRD + HCQ + MTX was more effective in reducing the LDL level and increasing the HDL level. To reduce the risk of cardiovascular diseases in patients with RA, it is important to prescribe the combination of drugs which leads and normalizes the lipid profile levels.

Effects of Levothyroxine and thyroid stimulating hormone on bone loss in patients with primary hypothyroidism.

OBJECTIVE: Previous studies on bone mineral density (BMD) abnormalities associated with hypothyroidism are scarce and not conclusive. The effect of thyroid hormone therapy on BMD has shown mixed results. The aim of the present study was to determine the severities of osteoporosis in female patients with hypothyroidism in comparison to healthy women. METHODS: This cross-sectional descriptive study was performed on 150 women aged over 50 years. Totally, 100 patients with primary hypothyroidism and 50 healthy subjects were enrolled in this study and divided into three groups. Group A, which consisted the patients who had been recently diagnosed with primary hypothyroidism. The second group of patients diagnosed with primary hypothyroidism for at least 2 years and was treated with levothyroxine (Group B). The third group of healthy individuals was selected as a control group (Group C). Blood samples were taken for the measurements of thyroid stimulating hormone (TSH), and bone densitometry was performed to determine the BMD reported as T-score in order to measure the severity of osteoporosis. T-score of the lumbar vertebra (L2-L4) and femoral neck were measured with dual energy X-ray absorptiometry and were compared between the three groups. Data were analyzed by SPSS using regression analysis and Mann-Whitney, Kruskal-Wallis, or analysis of variances statistical tests. The statistical significance was set at a P < 0.05. FINDINGS: The average age of patients and baseline serum TSH levels in Group B was significantly different from the other two groups (P < 0.001). T-score of the lumbar spine (L2-L4) in Group B was significantly lower than the other groups (P = 0.01). The linear regression between serum TSH levels and BMD categories were not clearly associated. However, after removing the effect of the baseline TSH level in Group B, bone loss was significantly greater than the other two groups (P = 0.01). CONCLUSION: According to the present study, it seems that the treatment of hypothyroidism with thyroid hormones reduces both serum levels of TSH and bone density. Hence, proper control of this risk factor can be an effective way in prevention of osteoporosis.

A case of sine scleroderma with parenchymal lung disease.

Systemic sclerosis sine scleroderma is a subtype of scleroderma, which is characterized by involvement of visceral organs, but no characteristic skin alteration. The involved organs could be kidneys, heart, gastrointestinal system, and lungs. Interstitial lung disease (ILD) is one of the pulmonary manifestations of sine scleroderma. We report a 38-year-old woman presenting with chill, fever, generalized malaise, dyspnea on exertion, and dry cough with a history of Raynaud's phenomenon, who was evaluated by physical examination, spirometry, and computed tomography scan, that all lead to the diagnosis of ILD. Combination of high-titer positive anti-nuclear antibody, high erythrocyte sedimentation rate, positive C-reactive protein, and ILD could be explained by sine scleroderma.

Effect of metformin on thyroid stimulating hormone and thyroid volume in patients with prediabetes: A randomized placebo-controlled clinical trial.

BACKGROUND: The people with prediabetes have insulin resistance (IR). IR may affect thyroid function, size and nodules. We investigated the effects of metformin on the thyroid gland in prediabetic people. MATERIALS AND METHODS: In a randomized, double-blind placebo-control clinical trial, 89 people with prediabetes, aged 18-65 years were studied for 3 months. They were divided into two, metformin (n = 43) and placebo (n = 46) treated groups. Serum thyroid stimulating hormone (TSH) was measured and thyroid nodules and volume was studied by ultrasonography. The data were compared between and within groups, before and after the study. RESULTS: Mean of the baseline characteristics in metformin and placebo-treated groups had no statistically significant difference. At the end of the study, serum TSH was not significantly different between the two groups. However, if the TSH range was divided into two low normal (0.3-2.5 µU/ml) and high-normal (2.6-5.5 µU/ml) ranges, significant decrease was observed in metformin-treated group with a high-normal basal serum TSH (P = 0.01). Thyroid volume did not change in metformin-treated group. However, in placebo-treated group, the thyroid was enlarged (P = 0.03). In 53.9% of participants, thyroid nodule was observed. There was just a decrease in the volume of small solid (not mixed) nodules from median of 0.07 ml to 0.04 ml in metformin-treated group (P = 0.01). CONCLUSION: In prediabetic people, metformin decreases serum TSH, only, in those people with TSH >2.5 µU/ml and reduces the size of small solid thyroid nodules. It also prevents an increase in the thyroid volume.

A case of Takayasu's arteritis with pulsatile neck mass.

Takayasu's arteritis (TA), also known as pulseless disease or occlusive thromboaortopathy, is a form of vasculitis of unknown cause that chiefly affects the aorta and its major branches, most frequently in young women. We describe an 18-year-old female with a soft and pulsatile mass in the left side of her neck.