Background: This study evaluated the efficacy and safety of add-on gemigliptin in patients with type 2 diabetes mellitus (T2DM) who had inadequate glycemic control with metformin and dapagliflozin. Methods: In this randomized, placebo-controlled, parallel-group, double-blind, phase III study, 315 patients were randomized to receive either gemigliptin 50 mg (n=159) or placebo (n=156) with metformin and dapagliflozin for 24 weeks. After the 24-week treatment, patients who received the placebo were switched to gemigliptin, and all patients were treated with gemigliptin for an additional 28 weeks. Results: The baseline characteristics were similar between the two groups, except for body mass index. At week 24, the least squares mean difference (standard error) in hemoglobin A1c (HbA1c) changes was –0.66% (0.07) with a 95% confidence interval of –0.80% to –0.52%, demonstrating superior HbA1c reduction in the gemigliptin group. After week 24, the HbA1c level significantly decreased in the placebo group as gemigliptin was administered, whereas the efficacy of HbA1c reduction was maintained up to week 52 in the gemigliptin group. The safety profiles were similar: the incidence rates of treatment-emergent adverse events up to week 24 were 27.67% and 29.22% in the gemigliptin and placebo groups, respectively. The safety profiles after week 24 were similar to those up to week 24 in both groups, and no new safety findings, including hypoglycemia, were noted. Conclusion Add-on gemigliptin was well tolerated, providing comparable safety profiles and superior efficacy in glycemic control over placebo for long-term use in patients with T2DM who had poor glycemic control with metformin and dapagliflozin.

BACKGROUND: The effects of dipeptidyl peptidase-4 inhibitors on adipokines remain obscure. The aim of this study was to evaluate the effect of the addition of vildagliptin on visfatin, an adipokine that represents inflammatory biomarkers of adipose tissue, in patients with type 2 diabetes inadequately controlled with prior metformin monotherapy. METHODS: In this 16-week, double-blind, randomized, parallel-group, placebo-controlled study, 71 patients were randomly assigned to vildagliptin 50 mg twice a day (n = 35) or placebo (n = 36) added to ongoing metformin therapy. Fasting plasma glucose (FPG), glycated hemoglobin (HbA1c), plasma lipids, and visfatin levels were measured at baseline and 16 weeks after treatment. RESULTS: After 16 weeks, significant reduction in HbA1c and FPG was observed with vildagliptin addon treatment compared to placebo (-0.54 +/- 0.52%, P = 0.001 and -14.80 +/- 19.21 mg/dL, P = 0.004, respectively). However, no other clinically meaningful changes in lipid parameters or visfatin were observed. CONCLUSION: Vildagliptin add-on to metformin significantly improved fasting blood glucose and HbA1c. However, in this study, no significant differences in lipid parameters or visfatin level were observed between the two groups.
Adipokines ; Adipose Tissue ; Biomarkers ; Blood Glucose ; Diabetes Mellitus ; Fasting ; Hemoglobin A, Glycosylated ; Humans ; Metformin ; Nicotinamide Phosphoribosyltransferase* ; Plasma ; Prospective Studies*

BACKGROUND: There are many studies regarding the effects of insulin on bone metabolism and changes in bone mineral density (BMD) in the setting of diabetes. The effect of prediabetes on BMD is not known. METHODS: A total of 802 men participated in the Korea Rural Genomic Cohort Study (in Geumsan County). According to the results of an oral glucose tolerance test, subjects were classified into normal, prediabetic, and diabetic categories. One hundred twenty-four subjects diagnosed with type 2 diabetes were excluded, leaving 678 subjects for the study inclusion. BMD was estimated with a quantitative ultrasonometer. RESULTS: The average BMD T scores of normal and prediabetic subjects were -1.34 +/- 1.42 and -1.33 +/- 1.30, respectively; there was no significant difference in the BMD T scores between these groups. The BMD T score was inversely associated with age and positively correlated with body weight, body mass index, total cholesterol, low density lipoprotein cholesterol, and HbA1c. On multiple linear regression analysis, low density lipoprotein cholesterol was the only statistically significant variable for prediabetes (beta = 0.007, P = 0.005). On the stepwise regression analysis, age (beta = -0.026, P < 0.001), the body mass index (beta = 0.079, P < 0.001), and low density lipoprotein cholesterol (beta = 0.004, P = 0.016) were significant variables for prediabetes. CONCLUSIONS: There was no significant difference in the BMD T score between the normal and prediabetic subjects. Further studies are needed regarding the association of fracture risk and changes in BMD with the development of overt diabetes.
Body Mass Index ; Body Weight ; Bone Density ; Cholesterol ; Cholesterol, LDL ; Cohort Studies ; Glucose Tolerance Test ; Humans ; Insulin ; Korea ; Linear Models ; Lipoproteins ; Male ; Prediabetic State

BACKGROUND: The target of the treatment of metabolic syndrome and diabetes is an improvement of insulin resistance. D-chiro-inositol (DCI) plays a role in a phospholipid mediating intracellular insulin action. In the previous studies, the urine level of DCI were decreased in the diabetic animal with insulin resistance. Some clinical studies showed that DCI improved a glucose level and HbA1c. Therefore we studied the relationship between DCI and glucose metabolism, especially insulin resistance. METHODS: To investigate the mechanism of DCI affecting the glucose metabolism, we examined the effects of DCI on 2-deoxyglucose uptake, gene expression of adipocytokines and AMPK pathway by using RT-PCR and western blot in 3T3-L1 cells. RESULTS: Insulin-stimulated 2-deoxyglucose uptake increased in DCI-treated cells by about 1.2-fold (relative to the control) and was inhibited by phosphoinositide 3-kinase (PI3 Kinase) inhibitors (Wortmanin, LY294002) and AMPK inhibitor (STO-609). In Western blot analysis, it didn't show the difference of phosphorylation of Akt and AMPK between DCI-treated group and control in 3T3-L1 cells. However, DCI decreased the gene expression of resistin in 3T3-L1 cells. CONCLUSION: DCI may involve other pathway of insulin signaling, but not PI3 Kinase and AMPK signaling pathways and it may be useful in managing metabolic syndrome by improving insulin resistance through increasing glucose uptake and decreasing resistin relevant to insulin resistance.
3T3-L1 Cells ; Adipokines ; Animals ; Blotting, Western ; Deoxyglucose ; Gene Expression ; Glucose ; Insulin ; Insulin Resistance ; Negotiating ; Phosphorylation ; Phosphotransferases ; Resistin

This study was conducted to evaluate the quantitative and qualitative aspects of Korean websites related to nutrition education. A total of 30 websites were ultimately selected through 4 major Internet search engines, including Naver, Yahoo, Daum, and Nate, using several key words (i.e., nutrition education, dietary life education, nutrition information, nutrition management, etc.). A systematic review was conducted for each of the selected websites based on the American Library Association (ALA) website checklist and a data abstract form that was adapted from a previous study. Approximately two thirds of the websites were established between 2002 and 2005, and 46.6% were administrated by public health centers or schools/colleges. The most frequently targeted group was the generally healthy population (30.0%). Among the various topics of nutrition information provided, "balanced diet" was the topic most often provided by the websites. Also, an increasing trend for utilizing multimedia tools was observed; however, little technical support or instruction was provided by the websites. Only 50.0% and 63.3% of the sites clearly stated their operators and sources of provided information, respectively. Overall, the purposes of sites were clearly stated, and were not overshadowed by advertising. And most features of design, stability, and content were found to be appropriate, but several aspects, such as establishing a help/FAQ menu, regularly updating nutrition information, and converting provided information into a database for easier search and update, needed improvement. In addition, active operational strategies are greatly needed to encourage the application of materials found on sites into real educational settings.
Checklist ; Internet ; Library Associations ; Multimedia ; Public Health ; Search Engine

No abstract available.
Adiponectin ; Humans ; Plasma

We present a case of severe hyponatremia in a 64-year-old man who had a pituitary tumor. He had nausea and recurrent vomiting with a severe headache, and was admitted to Chungnam National University Hospital for further evaluation. On physical examination, he was alert, and had bitemporal hemianopsia. There was no indication of dehydration or edema. Laboratory data showed a serum sodium level of 126 mEq/L, plasma osmolality of 259 mOsm/kg, and urinary osmolality of 544 mOsm/kg. The plasma argipressin level was 2.88 pg/mL, despite marked hyposmolality. Otherwise, pituitary function was normal. Brain magnetic resonance imaging showed a pituitary macroadenoma measuring 25x16x13 mm and no visible normal pituitary stalk or gland in the sella turcica. After the adenomectomy, the serum sodium level maintained normal without treatment. Histology showed the presence of a pituitary adenoma. These findings indicate that a non-functioning pituitary tumor may cause the exaggerated secretion of argipressin, resulting in inappropriate antidiuretic hormone syndrome.
Arginine Vasopressin ; Brain ; Chungcheongnam-do ; Dehydration ; Edema ; Headache ; Hemianopsia ; Humans ; Hyponatremia ; Inappropriate ADH Syndrome* ; Magnetic Resonance Imaging ; Middle Aged ; Nausea ; Osmolar Concentration ; Physical Examination ; Pituitary Gland ; Pituitary Neoplasms* ; Plasma ; Sella Turcica ; Sodium ; Vomiting

BACKGROUND: Fine needle aspiration(FNA) is an accurate and safe method for the diagnosis of thyroid nodules. One of the limitations of FNA is the variable rate of unsatisfactory specimens, especially in small sized, deep seated or complex cystic nodules. To overcome this problem, ultrasound-guided FNA(US-FNA) has been widely used. In this study, the adequacy of cytologic specimens by US-FNA was compared with that of conventional palpation-guided FNA(P-FNA). METHODS: The medical records of all patients who were engaged in FNA due to thyroid nodules at Chungnam National University Hospital from January 2003 to July 2004 were retrospectively examined. The US-FNA and P-FNA were performed in 114 and 185 patients, respectively. RESULTS: Comparison of the adequacy of the two techniques in providing sufficient material for the cytologic diagnosis showed that specimens in 24(13.0%) and 6(5.3%) patients collected by P-FNA and US-FNA, respectively, were unsatisfactory(P=0.031). A total of 23 patients underwent thyroid surgery due to strong suspicion of malignancy at cytologic finding and/or on clinical judgement. Seventeen patients belonged to the P-FNA group and 6 patients to the US-FNA group. In the P-FNA group, a histologic diagnosis revealed two false-negative cytologic findings, but no false-negative findings were found in the US-FNA group. CONCLUSION: Compared with P-FNA, US-FNA may reduce the possibility of unsatisfactory cytologic specimens and the rate of false-negative diagnosis, and may improve the diagnostic accuracy in investigating thyroid nodules
Biopsy, Fine-Needle* ; Chungcheongnam-do ; Diagnosis ; Humans ; Medical Records ; Needles ; Retrospective Studies ; Thyroid Gland* ; Thyroid Nodule*

BACKGROUND: Thyroid cancers account for about 1% of all human malignancies, with papillary thyroid carcinomas being the most common istotype. Several investigators have recently identified the most common BRAF mutation, the T1796A transversion mutation, in 29~69% of papillary thyroid cancers. The BRAF mutation has been demonstrated as a novel prognostic biomarker for the prediction of poor clinicopathological outcomes, such as increased incidence of extrathyroid invasion and distant metastasis of the tumor. In this study, we investigated the prevalence of the BRAF mutation of thyroid tissues obtained by a thyroidectomy, and its correlation with the clinicopathological outcomes. METHODS: We studied 36 thyroid tissues obtained from 24 women and 12 men by thyroidectomies, including 30 papillary carcinomas, 3 follicular carcinomas, 1 medullary carcinoma and 2 nodular hyperplasia. The mutation was sought in all specimens using DNA sequencing. RESULTS: We studied the BRAF exon 15 T1796A in these 36 thyroid tissues. The mean age at surgery was 46.6, ranging from 18 to 72 years, with a median tumor size of 2.79, ranging from 1.5 to 4.5cm. At the time of diagnosis, 27 of the 34 patients presented with some kind of extrathyroidal invasion of the tumor, and 16 had lymph node metastases. 16, 2 and 16 patients were in stages I, II and III, respectively. There was no distant metastasis. A missense mutation was found at T1796A in exon 15 in 21 of the 30 papillary carcinomas(70%). The other thyroid diseases, including the 3 follicular carcinomas, 1 medullary carcinoma and 2 nodular hyperplasia show no exon 15 T1759A transversion mutation. No statistically significant association was found between the BRAF mutations and clinicopathological characteristics of papillary carcinomas. CONCLUSION: The BRAF mutation is a important genetic alteration, with a high prevalence in papillary thyroid carcinomas. However, there was no significant association between the BRAF mutation and any of the clinicopathological factors. Further, large scale studies will be needed to evaluate the correlation between the BRAF mutation and the clinicopathological factors
Carcinoma, Medullary ; Carcinoma, Papillary* ; Diagnosis ; Exons ; Female ; Humans ; Hyperplasia ; Incidence ; Lymph Nodes ; Male ; Mutation, Missense ; Neoplasm Metastasis ; Prevalence ; Research Personnel ; Sequence Analysis, DNA ; Thyroid Diseases ; Thyroid Gland* ; Thyroid Neoplasms ; Thyroidectomy

BACKGROUND: Thyroid cancers account for about 1% of all human malignancies, with papillary thyroid carcinomas being the most common istotype. Several investigators have recently identified the most common BRAF mutation, the T1796A transversion mutation, in 29~69% of papillary thyroid cancers. The BRAF mutation has been demonstrated as a novel prognostic biomarker for the prediction of poor clinicopathological outcomes, such as increased incidence of extrathyroid invasion and distant metastasis of the tumor. In this study, we investigated the prevalence of the BRAF mutation of thyroid tissues obtained by a thyroidectomy, and its correlation with the clinicopathological outcomes. METHODS: We studied 36 thyroid tissues obtained from 24 women and 12 men by thyroidectomies, including 30 papillary carcinomas, 3 follicular carcinomas, 1 medullary carcinoma and 2 nodular hyperplasia. The mutation was sought in all specimens using DNA sequencing. RESULTS: We studied the BRAF exon 15 T1796A in these 36 thyroid tissues. The mean age at surgery was 46.6, ranging from 18 to 72 years, with a median tumor size of 2.79, ranging from 1.5 to 4.5cm. At the time of diagnosis, 27 of the 34 patients presented with some kind of extrathyroidal invasion of the tumor, and 16 had lymph node metastases. 16, 2 and 16 patients were in stages I, II and III, respectively. There was no distant metastasis. A missense mutation was found at T1796A in exon 15 in 21 of the 30 papillary carcinomas(70%). The other thyroid diseases, including the 3 follicular carcinomas, 1 medullary carcinoma and 2 nodular hyperplasia show no exon 15 T1759A transversion mutation. No statistically significant association was found between the BRAF mutations and clinicopathological characteristics of papillary carcinomas. CONCLUSION: The BRAF mutation is a important genetic alteration, with a high prevalence in papillary thyroid carcinomas. However, there was no significant association between the BRAF mutation and any of the clinicopathological factors. Further, large scale studies will be needed to evaluate the correlation between the BRAF mutation and the clinicopathological factors
Carcinoma, Medullary ; Carcinoma, Papillary* ; Diagnosis ; Exons ; Female ; Humans ; Hyperplasia ; Incidence ; Lymph Nodes ; Male ; Mutation, Missense ; Neoplasm Metastasis ; Prevalence ; Research Personnel ; Sequence Analysis, DNA ; Thyroid Diseases ; Thyroid Gland* ; Thyroid Neoplasms ; Thyroidectomy