Metformin administration in prevention of colorectal polyps in type 2 diabetes mellitus patients

BACKGROUND Colorectal polyps are frequently observed in patients with type 2 diabetes mellitus(DM),posing a significant risk for colorectal cancer.Metformin,a widely prescribed biguanidine drug for type 2 DM,has been suggested to have potential chemoprophylactic effects against various cancers.AIM To explore the correlation between colorectal polyps and metformin use in type 2 DM patients.METHODS Type 2 DM patients were categorized into polyp and non-polyp groups.Following this,all patients were categorized into the type 2 DM-metformin,type 2 DM-non-metformin,and non-type 2 DM groups.Based on the baseline colonoscopy results,we performed pairwise comparisons of the incidence of colorectal polyps among the three groups.Additionally,we analyzed the relationship between colorectal polyps and the duration of metformin use and between the size and number of polyps and metformin use.Simultaneously,we focused on the specific pathological types of polyps and analyzed their relationship with metformin use.Finally,we compared the incidence of polyps between metformin and non-metformin groups according to the interval colonoscopy results.RESULTS The rate of metformin use in patients with colorectal polyps was 0.502 times that of patients without colorectal polyps[odds ratio(OR)=0.502,95%confidence interval(CI):0.365-0.689;P<0.001].The incidence of colorectal polyps did not differ significantly between the type 2 DM-metformin and non-type 2 DM groups(P>0.05).Furthermore,the correlations between the duration of metformin use and the incidence of colorectal polyps and between the size and number of polyps and metformin use were not statistically significant(P>0.05).Metformin use did not affect the incidence of colorectal polyps during interval colonoscopy(P>0.05).CONCLUSION Metformin use and colorectal polyp incidence in type 2 DM patients showed a negative correlation,independent of the hypoglycemic effect of metformin.

Effects of different doses of metformin on bone mineral density and bone metabolism in elderly male patients with type 2 diabetes mellitus

BACKGROUND Diabetes is a chronic disease,which may cause various complications.Patients with diabetes are at high risk of bone and joint disorders,such as osteoporosis and bone fractures.In addition,it became widely accepted that diabetes has an important impact on bone metabolism.Metformin is a commonly used and effective first-line treatment for type 2 diabetes.Some glucose-lowering agents have been found to have an effect on bone metabolism.The present study explored if different doses of metformin have an effect on bone mineral density(BMD)and bone metabolism in type 2 diabetes.AIM To investigate the effects of different doses of metformin on BMD and bone metabolism in elderly male patients with type 2 diabetes mellitus.METHODS A total of 120 elderly male outpatients with type 2 diabetes mellitus who were admitted to our hospital were included in the study from July 2018 to June 2019.They were randomly assigned to an experimental group and a control group with 60 patients in each group.Patients in the experimental group were given high dose metformin four times a day 0.5 g each time for 12 wk.Patients in the control group were given low dose metformin orally twice a day 0.5 g each time for 12 wk.The changes in bone mineral density and bone metabolism before and after treatment and the efficacy rate of the treatment were compared between the two groups.RESULTS There was no significant difference in the efficacy rate between the two groups(P>0.05).Before the treatment,there was no significant difference in BMD and bone metabolism between the two groups(P>0.05).However,after the treatment,BMD and bone metabolism were improved in the two groups.Moreover,BMD and 25-hydroxyvitamin D were significantly higher in the experimental group than in the control group,and N-terminal/midregion andβ-isomerized Cterminal telopeptides were significantly lower in the experimental group than in the control group(all P<0.05).There was no significant difference in the incidence of adverse reactions between the two groups(P>0.05).CONCLUSION Both high and low dose metformin can effectively control the blood glucose levels in elderly male patients with type 2 diabetes mellitus.However,the benefits of high dose metformin in improving BMD and bone metabolism level was more obvious in patients with type 2 diabetes mellitus.

Impacts of statin and metformin on neuropathy in patients with type 2 diabetes mellitus: Korean Health Insurance data

BACKGROUND Neuropathy is a common chronic complication in type 2 diabetes mellitus(T2DM).Statin and metformin are commonly used medications in T2DM patients,and some studies showed statin-or metformin-induced neuropathy.AIM To evaluate the incidence of neuropathy among patients with T2DM associated with statin and metformin therapies.METHODS Korean Health Insurance Review and Assessment national patient sample data from 2016 and 2017 were used.Patients with T2DM and no complications were divided into statin/metformin/statin+metformin users and non-users.Neuropathy incidence was defined by International Statistical Classification of Diseases and Related Health Problems,10th revision codes and concomitant prescriptions for anticonvulsants or antidepressants.Logistic regression analyses were conducted to examine the associations between statin/metformin/statin+metformin therapies and the incidence of neuropathy.Propensity score(PS)matching was performed on the basis of age,sex and comorbidities.RESULTS Overall,34964 and 35887 patients with T2DM and no complications were included in the Korean Health Insurance Review and Assessment national patient sample datasets from 2016 and 2017,respectively.Statin therapy was associated with increased risks of neuropathy in 2016 and 2017[PS-matched odds ratio(OR)=1.22,95%confidence interval(CI):1.08-1.38;PS-matched OR=1.17,95%CI:1.03-1.33,respectively].Metformin therapy was associated with reduced risks of neuropathy in 2016 and 2017(PS-matched OR=0.30,95%CI:0.21-0.42;PSmatched OR=0.44,95%CI:0.32-0.60,respectively).Combined statin+metformin therapy was not significantly associated with neuropathy in 2016 or 2017(PSmatched OR=0.85,95%CI:0.61-1.19;PS-matched OR=0.95,95%CI:0.66-1.38,respectively).CONCLUSION Statin therapy was associated with enhanced risk of new-onset neuropathy in patients with T2DM,but metformin therapy showed the opposite association.

Effects of insulin aspart and metformin on gestational diabetes mellitus and inflammatory markers

BACKGROUND Gestational diabetes mellitus(GDM)refers to hyperglycemia caused by insulin resistance or insufficient insulin secretion during pregnancy.Patients with GDM have a high risk of pregnancy complications,which can adversely affect both maternal and fetal health.Therefore,early diagnosis,treatment and monitoring of GDM are essential.In recent years,a new treatment scheme represented by insulin aspart combined with metformin has received increasing attention.AIM To explore the effects of insulin aspart combined with metformin on patients with GDM and inflammatory markers.METHODS From April 2020 to September 2022,124 patients with GDM in Sanya Women and Children’s Hospital Managed by Shanghai Children’s Medical Center were collected and analyzed retrospectively.The control group(CG)comprised 62 patients treated with insulin aspart alone,and 62 patients treated with insulin aspart and metformin formed the observation group(OG).Before and after treatment,improvement of blood-glucose-related indexes[fasting blood glucose(FBG),2-h postprandial glucose(2h PG)and hemoglobin A1c(HbA1c)],serum related factor[serum homocysteine(Hcy)],serum inflammatory cytokines[tumor necrosis factor(TNF)-α,interleukin(IL)-6 and C-reactive protein(CRP)]were compared between the two groups.The clinical efficacy,adverse pregnancy outcomes and incidence of pregnancy complications were compared between the two groups.RESULTS After treatment,the levels of FBG,2h PG,HbA1c,Hcy,TNF-α,IL-6 and CRP in both groups were significantly decreased(P<0.05),and the levels of FBG,2h PG,HbA1c,Hcy,TNF-α,IL-6 and CRP in the OG were lower than in the CG(P<0.05).The total clinical effectiveness in the OG was higher than that in the CG(P<0.05).The total incidence of adverse pregnancy outcomes and complications in the OG was significantly lower than in the CG(P<0.05).CONCLUSION Insulin aspart combined with metformin are effective for treatment of GDM,which can reduce blood-glucoserelated indexes,Hcy and serum inflammatory cytokines,and risk of adverse pregnancy outcomes and complications.

Long-term effects of metformin use in gestational diabetes mellitus on offspring health

Metformin is the first-line drug for the treatment of type 2 diabetes mellitus,but its role in gestational diabetes mellitus(GDM)management is not clear.Recent evidence suggests a certain beneficial effect of metformin in the treatment of GDM,but a high treatment failure rate leads to the initiation of additional medications,such as insulin.Moreover,since metformin crosses the placental barrier and reaches a significant level in the fetus,it is likely to influence the fetal metabolic milieu.The evidence indicates the long-term safety in children exposed to metformin in utero except for mild adverse anthropometric profiles.Diligent follow-up of metformin-exposed offspring is warranted from the clinician’s point of view.

Prognostic role of metformin in diabetes mellitus type 2 patients with hepatocellular carcinoma:A systematic review and meta-analysis

BACKGROUND Hepatocellular carcinoma(HCC)is among the commonest malignancies associated with significant cancer-related death.The identification of chemopreventive agents following HCC treatments with the potential to lower the risk of HCC adverse course is intriguing.Metformin,a first-line agent used in the treatment of type 2 diabetes mellitus(T2DM),has been associated with inhibition of HCC growth.AIM To determine whether metformin can prevent adverse events(i.e.,death,tumor progression,and recurrence)after any HCC treatment in T2DM patients.METHODS A systematic review of the published literature was undertaken focused on the role of metformin on outcomes in patients with T2DM and HCC receiving any tumor therapy.A search of the PubMed and Cochrane Central Register of Controlled Trials Databases was conducted.RESULTS A total of 13 studies(n=14886 patients)were included in this review.With regard to the risk of death,a decreased risk was reported in cases receiving metformin,although this decrease was not statistically significant[odds ratio(OR)=0.89,P=0.42].When only patients treated with curative strategies were considered,a more marked correlation between metformin and favorable cases was reported(OR=0.70,P=0.068).When analyzing palliative treatment,there was no statistical significance in terms of the correlation between metformin and favorable cases(OR=0.74,P=0.66).As for the risks of progressive disease and recurrence,no obvious correlation between metformin use and reduced risk was reported.When sub-analyses were performed for patients from different regions,the results for patients from Eastern countries showed a tendency for decreased risk of death in T2DM cases receiving metformin(OR=0.69,P=0.17),but the same was not seen in patients from Western countries(OR=1.19,P=0.31).CONCLUSION Metformin failed to show a marked impact in preventing adverse effects after HCC treatment.A trend was reported in T2DM cases receiving curative therapies in relation to the risk of death,especially in patients from Eastern regions.Great heterogeneity was reported among the different studies.Further large studies are required to definitively clarify the real impact of metformin as a chemopreventive agent for HCC.

Berberine and Metformin in the Treatment of Type 2 Diabetes Mellitus: A Systemic Review and Meta-Analysis of Randomized Clinical Trials

Objective: To assess the effects of berberine and metformin on glucose in patients with type 2 diabets mellitus (T2DM) with a systematic review and meta-analysis. Methods: The databases including PubMed, Excerpta Medica Database (EMBase), Cochrane Library, Chinese National Knowledge Infrastructure database (CNKI), WanFang, the Chinese Scientific and Technical Journals database (VIP), China Doctor Dissertation Full-text Database (CDFD) and China Master Dissertation Full-text Database (CMFD) from the inception to April 2021 in Chinese or English language were searched. Randomized controlled trials (RCTs) of berberine only or combined with metformin versus metformin were included. Data extraction and paper quality assessment were conducted according to the Cochrane Handbook. RevMan 5.4 was used for the meta-analysis. Results: A total of thirteen studies were included, covering 1173 participants. The clinical heterogeneity of the included trials was relatively high. The methodological quality of most trials was generally low with bias in terms of random sequence generation, allocation concealment, blinding method, outcome data and selective reporting. Interventions were divided into two subgroups for analysis. Meta-analysis suggested that there was no statistical significance in the hypoglycemic effect between berberine and metformin for T2DM. However, berberine combined with metformin could reduce fasting plasma glucose (FPG) [MD = −1.49, 95% CI (−2.22, −0.76), P < 0.0001], 2-hour postprandial blood glucose (2hPG) [MD = −1.89, 95% CI (−2.94, −0.84), P = 0.0004], glycosylated hemoglobin A1c (HbA1c) [MD = −0.65, 95% CI (−0.91, −0.40), P < 0.00001] and homeostasis model assessment of insulin resistance (HOMA-IR) [MD = −0.53, 95% CI (−1.03, −0.03), P = 0.04] levels significantly compared with metformin group. No severe adverse effects were reported in all trials. Conclusions: The hypoglycemic effect of berberine alone is not better than metformin. But berberine combined with metformin has good efficacy and safety in the treatment of T2DM. The current clinical studies are low in methodology and reporting quality, which needs to be further proved by more high quality, large sample size and multi-center RCTs.

Effect of insulin and metformin on methylation and glycolipid metabolism of peroxisome proliferator-activated receptor γcoactivator-1A of rat offspring with gestational diabetes mellitus

Objective:To discuss the effect of insulin and metformin on amethylation and glycolipid metabolism of peroxisome proliferator-activated receptor γ coactivator-1A(PPARGC1A) of rat offspring with gestational diabetes mellitus(GDM).Methods:A total of 45 pregnant rats received the intraperitoneal injection of streptozotocin to establish the pregnant rat model of GDM.A total of 21 pregnant rats with GDM were randomly divided into three groups,with 7ruts in each group,namely the insulin group,metformin group and control group.Rats in the insulin group received the abdominal subcutaneous injection of 1 mL/kg recombinant insulin glargine at 18:00 every day.Rats in the metformin group received the intragastric infusion of metformin hydrochloride at 18:00 every day,with the first dose of 300 mg/kg.The doses of two groups were adjusted every 3 d to maintain the blood glucose level at 2.65-7.62 mmol/L.Rats in the control group received the intragastric infusion of 1 mL normal saline at 18:00 every day.After the natural delivery of pregnant rats.10 offspring rats were randomly selected from each group.At birth,4 wk and 8 wk after the birth of offspring rats,the weight of offspring rats was measured.The blood glucose level of offspring rats was measured at 4wk and 8 wk,while the level of serum insulin,triglyceride and leptin was measured at 8 wk.Results:The weight of offspring rats at birth in the insulin group and metformin group was significantly lower than the one in the control group(P<0.05),and there was no significant difference at 4 wk and 8 wk among three groups(P>0.05).The fasting blood glucose and random blood glucose in the insulin group and metformin group at 4 wk and 8 wk were all significantly lower than ones in the control group(P<0.05);there was no significant difference between the insulin group and metformin group(P>0.05).The expression of PPARGC1 A mRNA in the insulin group and metformin group was significantly higher and the methylation level of PPARGC1 A was significantly lower than the one in the control group(P<0.05),but there was no significant difference between the insulin group and metformin group(P>0.05).Insulin and leptin at 8 wk in the insulin group and metformin group were significantly higher,while triglyceride was significantly lower than the one in the control group(P<0.05);triglyceride level of rats in the insulin group was significantly higher than the one in the metformin group(P<0.05).There was no significant difference in insulin and leptin level of offspring rats between the insulin group and metformin group(P>0.05).Conclusions:GDM can induce the methylation of PPARGC1 A of offspring rats to reduce the expression of PPARGC1 A mRNA and then cause the disorder of glycolipid metabolism when the offspring rats grow up;the insulin or metformin in the treatment of pregnant rats with GDM can reduce the methylation level of PPARGC1 A and thus improve the abnormal glycolipid metabolism of offspring rats.

Diabetes mellitus and metformin in hepatocellular carcinoma

Hepatocellular carcinoma(HCC) is the leading cause of cancer-related death worldwide. Diabetes mellitus, a risk factor for cancer, is also globally endemic. The clinical link between these two diseases has been the subject of investigation for a century, and diabetes mellitus has been established as a risk factor for HCC. Accordingly, metformin, a first-line oral anti-diabetic, was first proposed as a candidate anti-cancer agent in 2005 in a cohort study in Scotland. Several subsequent large cohort studies and randomized controlled trials have not demonstrated significant efficacy for metformin in suppressing HCC incidence and mortality in diabetic patients; however, two recent randomized controlled trials have reported positive data for the tumor-preventive potential of metformin in non-diabetic subjects. The search for biological links between cancer and diabetes has revealed intracellular pathways that are shared by cancer and diabetes. The signal transduction mechanisms by which metformin suppresses carcinogenesis in cell lines or xenograft tissues and improves chemoresistance in cancer stem cells have also been elucidated. This review addresses the clinical and biological links between HCC and diabetes mellitus and the anti-cancer activity of metformin in clinical studies and basic experiments.

Effect of DPP-4 inhibitor combined with metformin on glucose and lipid metabolism and micro-inflammatory state in patients with type 2 diabetes mellitus complicated by metabolic syndrome

Objective: To study the effect of DPP-4 inhibitor combined with metformin on glucose and lipid metabolism and micro-inflammatory state in patients with type 2 diabetes mellitus complicated by metabolic syndrome. Methods: A total of 60 patients with type 2 diabetes mellitus complicated by metabolic syndrome who were treated in the hospital between February 2015 and December 2016 were divided into control group (n=30) and observation group (n=30) according to the random number table method. Control group received metformin therapy alone, observation group received DPP-4 inhibitor combined with metformin therapy, and the differences in levels of glucose and lipid metabolism indexes and inflammatory factors were compared between the two groups of patients before and after treatment. Results: Before treatment, the differences in glucose and lipid metabolism index levels in peripheral blood as well as inflammatory factor contents in serum were not statistically significant between the two groups. After treatment, the levels of glucose metabolism indexes FPG, FPI and HOMA-IR as well as lipid metabolism indexes TG and TC in peripheral blood of observation group were lower than those of control group while HDL-C level was higher than that of control group;the contents of inflammatory factors IL-6, CRP and TNF-α in serum were lower than those of control group. Conclusion: DPP-4 inhibitor combined with metformin therapy is more effective in controlling the glucose and lipid metabolism process and inhibiting the micro-inflammatory state in patients with type 2 diabetes mellitus complicated by metabolic syndrome.

Clinical Study on Dark Tea with Pericarpium Citri Reticulatae Combined with Metformin for Type 2 Diabetes Mellitus

[Objectives]To observe the clinical effect of dark tea with pericarpium citri reticulateae combined with metformin for type 2 diabetes mellitus.[Methods]A total of 80 cases of patients with type 2 diabetes mellitus were randomly divided into the control group and the observation group with 40 cases in each group.The control group was given metform for treatment,and the observation group was given dark tea with pericarpium citri reticulateae combined with metformin for treatment.The two groups were continuously treated for 12 weeks.The indexes of patients were observed and recorded,such as the body mass index(BMI),abdominal circumference(AC),hemoglobin A1c(HbA1c),fasting blood glucose(FBG),postprandial 2 h blood glucose(P2hBG),uric acid(UA),total cholesterol(TC),and triglyceride(TG).The incidence of adverse reactions during the treatment period and the patient satisfaction for treatment in the two groups were counted.[Results]After treatment,the FBG,P2hBG and HbA1c in the two groups were decreased when compared with those before treatment(P<0.05)and the decrease of the above indexes in the observation group was more significant than that in the control group(P<0.05).After treatment,the BMI,AC,UA,TC and TG in the observation group were decreased more significantly when compared with those before treatment and those in the control group after treatment,differences were statistically significant(P<0.05).The above indexes in the control group did not change significantly before and after treatment(P>0.05).The incidence of adverse reactions was 2.5%in the observation group and 5.0%in the control group,the difference was not statistically significant(P>0.05).The patient satisfaction was 97.5%in the observation group and 55.0%in the control group,the difference was significant(P<0.05).[Conclusions]The curative effect of dark tea with pericarpium citri reticulateae combined with metformin for type 2 diabetes mellitus is better than that of western medicine alone and has no obvious adverse reactions,thus it is worthy of clinical promotion and application.

Effect of metformin and Pioglitazone on insulin dose reduction in type 2 diabetes mellitus patients: An open level comparative prospective study

Insulin therapy cause weight gain and may increase its own requirement. Type 2 diabetes mellitus is associated with insulin resistance and affect both endogenous and exogenous insulin effect. Metformin and Pioglitazone, commonly used insulin sensitizers, have the potentiality of reducing the insulin dose, in Type-2 diabetes mellitus (T2DM) patients. This study was held to assess and compare such potentiality. 40 T2DM patients not controlled by diet, exercise and oral antidiabetic agents were selected for this study. Study had observed that Pioglitazone and metformin both significantly had reduced the dose of insulin. But metformin reduce the dose of insulin significantly more than that of Pioglitazone. Metformin had reduced the triglyceride, LDL-c, waist hip ratio significantly but modestly increased serum lactic acid and HDL-c. It can be concluded that co-administration of metformin with insulin is more beneficial in relation to the dose of insulin, waist hip ratio, and lipid modification when compare to Pioglitazone.

Marked Improvement in Glycemic Control with Exenatide on Addition to Metformin, Sulfonylurea and Insulin Glargine in Type 2 Diabetes Mellitus, a Real World Experience

Background: The major effect of Exenatide is attributed to lowering of post-prandial glycemia, whereas insulin glargine mainly improves fasting glycemia [FPG]. Objective: Therefore, we assessed effect of Exenatide administration at 6 months and for at 1 year on glycemic control, lipids, body weight [BW], daily insulin dose and hypoglycemic events. Methods: Records of 164 subjects, 126 men and 38 women administered Exenatide between January 2011 and December 2013 are included in this report. Exenatide was initiated at 5 mcg subcutaneously twice daily [BID] in obese subjects, BMI > 30 kg/m2, with C-peptide > 1 ng/d, and HbA1c 7.5% - 9.5%, while receiving daily metformin 2000 mg, Sulfonylurea Glimepiride 8 mg and insulin Glargine [GLAR]. Exclusion criteria were creatinine > 1.5 mg/dL and liver enzymes > 2.5 times upper limit of normal. Indices of glycemic control include fasting plasma glucose levels and HbA1c. Lipids include serum concentrations of total, LDL and HDL cholesterol. Other endpoints are body weight, daily insulin dose and number of hypoglycemic events per patient during 4 weeks prior to initiation of Exenatide, at 6 months and 1 year of therapy. Results: In 37 subjects, Exenatide was discontinued within 1 - 3 weeks;29 due to onset of nausea and vomiting. Seven of these also complained of abdominal pain and in these, serum amylase and lipase were elevated indicating presence of acute pancreatitis. One subject discontinued because of chest pain. Fasting plasma Glucose remained unchanged following Exenatide administration. However, HbA1c declined significantly denoting improvement in overall glycemic control without significant changes in body weight, daily insulin dose and hypoglycemic events. Lipid panel improved as well. Conclusion: Exenatide may be an appropriate adjuvant option in obese subjects with Type 2 diabetes mellitus with lack of desirable glycemic control while receiving therapy with Metformin, Glimepiride, and insulin Glargine. Moreover, improvement in glycemic control is likely to be secondary to lowering of post prandial hyperglycemia induced by Exenatide.

Dose-dependent relationship between serum metformin levels and glycemic control, insulin resistance and leptin levels in females newly diagnosed with type 2 diabetes mellitus

Despite the extensive clinical experience with the use of metformin worldwide, no formal dose-ranging study has been conducted because the current dosing strategy of metformin was determined empirically, rather than by an understanding of its dose-response relationship in patients with type 2 diabetes. The present study was designed to evaluate the correlation between serum metformin levels and glycemic control, insulin resistance and leptin levels in females newly diagnosed with type 2 diabetes. Sixty type 2 diabetic females were recruited for the study and were allocated into 3 groups;each receiving metformin 1000, 1500 and 2000 mg/day respectively for 3 months. Blood samples withdrawn from each patient at zero time and after 3 months is used to evaluate serum levels of HbA1c, glucose, leptin and insulin, in addition, the measurement of serum level of metformin in blood after 3 months by HPLC. The results demonstrated that all the treated groups with different doses of metformin showed significant improve in all parameters;the use of increased metformin doses was only correlated with plasma leptin levels in the highest dose. In conclusion, serum metformin levels are not good predictors for correlating improvement in clinical and biochemical parameters with increasing the dose in newly diagnosed non-insulin resistant females with type 2 diabetes.

Effectiveness of Telmisartan as an Adjunct to Metformin in Treating Type II Diabetes Mellitus in Rats

The monitoring reports of most patients with type II diabetes mellitus (T2DM) revealed that monotherapy with metformin could not achieve long-term glycemic control. Thus, we designed this study aiming to investigate the effect of telmisartan, a unique AT1 receptor antagonist and a partial agonist of peroxisome-proliferator activated receptor gamma (PPARγ), individually and as an adjunct to metformin, on a rat model that simulates the metabolic characteristics of human T2DM. Adult male Wistar rats were fed high-fat, high-fructose diet (HFFD) for 8 weeks followed by a single low dose of streptozotocin (STZ) (35 mg/kg/day, i.p.) rendering them diabetic and insulin resistant. The effectiveness of both drugs and their combination was tested by assessing the changes in the levels of serum glucose, insulin, homeostasis model assessment of insulin resistance (HOMA-IR) index, lipid profile and adiponectin. In addition, the level of reduced glutathione (GSH) in the liver, was investigated. Results showed that the addition of telmisartan to metformin successfully restored serum glucose back to normal levels and corrected the altered serum total cholesterol (TC), triglycerides (TG) and adiponectin, emphasizing the potential role of telmisartan as an adjunct to metformin.

Efficacy and Safety of PDM011011 Capsules as Compared to Metformin in Subjects with Type-2 Diabetes Mellitus: An Open-Label, Randomized, Active-Controlled, Multicentric, Phase III Study

Context: Bitter melon (Momoradica charantia) is one of the well-known plants used for lowering blood glucose since antiquity. Aims: To compare the efficacy and safety of PDM011011 capsule (1200 mg/day) with Metformin (1000 mg/day) in a 15 weeks study using mean change in fasting plasma glucose (FPG) and Hb1Ac% in subjects with type 2 diabetes mellitus (T2DM). Settings and Design: This is an open-label, randomized, active-controlled, multicentric, phase III study. Methods and Material: A total of 123 eligible patients were randomized in 2:1 ratio in PDM011011 and Metformin arm. Total 83 subjects received PDM011011 capsule (1200 mg/day) and 40 subjects received Metformin (1000 mg/day) in their respective arms for 15 weeks. Subjects were analyzed for FPG and Hb1Ac% at baseline and during treatment visits (Visit 3 to Visit 7). Safety assessments were carried out. Results: In this study, the significant reduction in mean FPG level was observed after treatment with PDM011011 capsule and Metformin in T2DM patients. The mean change from baseline to week 15 in FPG was 14.52 mg/dL (95% CI: 6.36, 22.67) in the PDM011011-treated subjects and 28.34 mg/dL (95% CI: 21.35, 35.32) in the Metformin-treated subjects. At week 15, the mean change from baseline in HbA1c levels was 0.27% (95% CI: 0.06, 0.47) in the PDM011011 arm and 0.62% (95% CI: 0.40, 0.83) in the Metformin arm. Conclusion: PDM011011 capsule (1200 mg/day) exhibited the modest efficacy and safety as compared to Metformin (1000 mg/day) in type 2 diabetes patients.

Effects of DPP-4 inhibitor combined with metformin on blood glucose control, oxidative stress and inflammatory response in patients with type 2 diabetes mellitus

Objective: To investigate the effects of DPP-4 inhibitor combined with metformin on blood glucose control, oxidative stress and inflammatory response in patients with type 2 diabetes mellitus (T2DM). Methods: A total of 138 patients with newly diagnosed T2DM who were treated in the hospital between March 2016 and April 2017 were divided into routine group (n=69) and combined treatment group (n=69) by random number table method. Routine group were treated with metformin alone and combined treatment group received DPP-4 inhibitor combined with metformin therapy. The differences in blood glucose control as well as oxidative stress-related indicator and inflammatory factor contents were compared between the two groups before and after treatment. Results: Before treatment, the differences in blood glucose index levels in peripheral blood as well as the oxidative stress index and inflammatory mediator contents in serum were not statistically significant between the two groups. After 4 weeks of treatment, blood glucose indexes FBG and HOMA-IR levels in peripheral blood of combined treatment group were lower than those of routine group;oxidative stress indexes MDA and LHP contents in serum were lower than those of routine group whereas GSH-Px and T-AOC contents were higher than those of routine group;inflammatory mediators hs-CRP, IL-1 and IL-6 contents in serum were lower than those of routine group. Conclusion: DPP-4 inhibitor combined with metformin therapy can effectively control the blood glucose and suppress the systemic oxidative stress and inflammatory response in T2DM paients.

Role of nutrition in diabetes mellitus and infections

In this editorial,we have commented on the article that has been published in the recent issue of World Journal of Clinical Cases.The authors have described a case of unilateral thyroid cyst and have opined that the acute onset of infection may be linked to diabetes mellitus(DM).We have focused on the role of nutrition in the association between DM and infection.Patients with DM are at a high risk of infection,which could also be attributed to nutrition-related factors.Nutritional interventions for patients with diabetes are mainly based on a low-calorie diet,which can be achieved by adhering to a low-carbohydrate diet.However,dietary fiber supplementation is recommended to maintain the diversity of the gut microbiota.Furthermore,high-quality protein can prevent the increased risk of infection due to malnutrition.Supplementation of vitamins C,vitamins A,vitamins D,and folic acid improves blood sugar control and facilitates immune regulation.Mineral deficiencies augment the risk of infection,but the relationship with diabetes is mostly U-shaped and a good intake should be maintained.

Microplastic and nanoplastic exposure and risk of diabetes mellitus

The issue of plastic pollutants has become a growing concern.Both microplastics(MPs)(particle size<5 mm)and nanoplastics(NPs)(particle size<1μm)can cause DNA damage,cytotoxicity,and oxidative stress in various organisms.The primary known impacts of microplastic/nanoplastic are observed in the liver and respiratory system,leading to hepatotoxicity and chronic obstructive pulmonary disease.Although research on the effects of MPs and NPs on diabetes is still in its early stages,there are potential concerns.This editorial highlights the risk to diabetics from co-exposure to contaminants and MPs/NPs,supported by evidence from animal studies and the various chemical compositions of MPs/NPs.

Intricacies during pregnancy with gestational diabetes mellitus

The study by Cao et al aimed to identify early second-trimester biomarkers that could predict gestational diabetes mellitus(GDM)development using advanced proteomic techniques,such as Isobaric tags for relative and absolute quantitation isobaric tags for relative and absolute quantitation and liquid chromatography-mass spectrometry liquid chromatography-mass spectrometry.Their analysis revealed 47 differentially expressed proteins in the GDM group,with retinol-binding protein 4 and angiopoietin-like 8 showing significantly elevated serum levels compared to controls.Although these findings are promising,the study is limited by its small sample size(n=4 per group)and lacks essential details on the reproducibility and reliability of the protein quantification methods used.Furthermore,the absence of experimental validation weakens the interpretation of the protein-protein interaction network identified through bioinformatics analysis.The study's focus on second-trimester biomarkers raises concerns about whether this is a sufficiently early period to implement preventive interventions for GDM.Predicting GDM risk during the first trimester or pre-conceptional period may offer more clinical relevance.Despite its limitations,the study presents valuable insights into potential GDM biomarkers,but larger,well-validated studies are needed to establish their predictive utility and generalizability.