Safety and anti-diabetic efficacy of a novel, proprietary Trigonella foenum-graecum seed extract [novel fenugreek extract (FE), Fenfuro™, CR0010810) enriched in furostanolic saponins (>60% w/w, HPLC) were assessed. Concerning safety, we undertook studies dealing with acute oral toxicity, 28-d sub-chronic toxicity and Ames' bacterial reverse mutation assay that revealed no toxicity. Concerning efficacy, we examined beneficial effects of the extract on rats with type 2 diabetes (T2D). Male Sprague-Dawley rats received a high-fat diet for 2 weeks followed by streptozotocin (STZ, 35 mg/kg i.p.) to produce T2D. Seven days post-STZ, rats showing ≥300 mg/dl fasting plasma glucose level (PGL) were included in the study. FE (150- or 450- mg/kg p.o.) and glipizide (5 mg/kg p.o.) were administered once daily for 20 d and then twice daily for another 10 d (total 30 d). Blood samples were collected at 0, 10, 20 and 30 d of treatment and estimated for fasting plasma triglyceride (PTG), total cholesterol and insulin levels. After 30 d, FE and glipizide-treated diabetic animals were treated in combination with or without metformin (100 mg/kg) twice daily for another 10 d. FE did not influence body weight, feed and water intake. FE (150 mg/kg p.o.) reduced PTG levels in T2D rats by 22%, 24.6% and 29% at 10, 20 and 30 d of treatment, respectively, while glipizide (5 mg/kg p.o.) reduced the PTG levels by 57.4%, 46.2% and 39.4% at these time points. FE (450 mg/kg) treatment in STZ-induced diabetic rats produced significant hypoglycemic activity (approximately 31.5%) as compared to insulin (48.2% with 1 U/kg i.p.). FE (150 mg/kg p.o.) and metformin (100 mg/kg p.o.) combined produced significant reduction (20.7%) of PGL in T2D rats. No adverse effects were observed. We conclude after extensive in vitro and in vivo safety and efficacy studies that FE is safe and effective in treating T2D.
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ClinicalTrials.gov Identifier: NCT00316082.
Five patients did not complete the study and were therefore excluded from analysis: this left 12 HIIT and 11 control patients for the intention-to-treat analysis. Compared with controls, HIIT improved cardiac structure (left ventricular wall mass 104 ± 17 g to 116 ± 20 g vs. 107 ± 25 g to 105 ± 25 g, p < 0.05) and systolic function (stroke volume 76 ± 16 ml to 87 ± 19 ml vs. 79 ± 14 ml to 75 ± 15 ml, p < 0.01). Early diastolic filling rates increased (241 ± 84 ml/s to 299 ± 89 ml/s vs. 250 ± 44 ml/s to 251 ± 47 ml/s, p < 0.05) and peak torsion decreased (8.1 ± 1.8° to 6.9 ± 1.6° vs. 7.1 ± 2.2° to 7.6 ± 1.9°, p < 0.05) in the treatment group. Following HIIT, there was a 39% relative reduction in liver fat (p < 0.05) and a reduction in HbA1c (7.1 ± 1.0% [54.5 mmol/mol] to 6.8 ± 0.9% [51.3 mmol/mol] vs. 7.2 ± 0.5% [54.9 mmol/mol] to 7.4 ± 0.7% [57.0 mmol/mol], p < 0.05). Changes in liver fat correlated with changes in HbA1c (r = 0.70, p < 0.000) and 2 h glucose (r = 0.57, p < 0.004). No adverse events were recorded.
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Two PCOS groups of patients of reproductive age (90 lean and 88 obese or overweight) with two control groups, adjusted for body mass index (BMI), were compared at baseline. 32 PCOS women were studied at baseline, after three and six months of metformin (1,000 mg/day) treatment. Clinical, anthropometric, biochemical and hormonal parameters were assessed.
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The incidence of type 2 diabetes and obesity in children and adolescents has risen at staggering rates. Studies have shown that treating type 2 diabetes with oral medications in children may be more difficult than treating in adults. Compounding this problem is the fact that most of the medications available for treating type 2 diabetes have not been studied in children. Recently, the American Diabetes Association and the Pediatric Endocrine Society have collaborated to create a guideline for the treatment of type 2 diabetes in children. Similar to the treatment of adults with type 2 diabetes, metformin remains the mainstay of therapy along with diet and exercise. Adjunctive therapy should be based on the limited clinical evidence available as well as on patient preference. In order to avoid detrimental microvascular and macrovascular complications, patients, clinicians, and family members should work together to ensure adequate treatment of type 2 diabetes in children.
This study reports a literature review aimed to analyse various studies related to the use of phytotherapy in diabetes mellitus in Turkey in order to provide additional information for healthcare professionals. The incidence of Diabetes Mellitus is rising and many of the diabetics frequently use herbal treatments along with modern medical treatment for glycaemic control and/or improve their well-being. Several electronic databases (such as Medline and Pubmed) were searched for 1990-2010 period (till May, 2010) and 33 related articles were analysed. Many studies--mostly animal trials- have been conducted in this field. Among the herbs most-commonly used along with modern medical therapies and also in folkloric medicine, we searched for bitter melon, cinnamon, fenugreek, olive leaf, black seed and white mulberry. Studies conducted in this field have produced conflicting results and, the necessity to conduct randomized, placebo-controlled clinical human studies to develop new drugs from herbs, as in the case of metformin, still remains important. Besides, further studies are required to address the issues of standardization and quality control of existing preparations. More importantly, healthcare professionals caring for diabetic patients need to be aware of phytotherapy to incorporate phytomedicine into their practices and should undertake more responsibility in relation to these kind of therapies that are commonly-used throughout the world.
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Wistar albino rats, rendered diabetic with streptozotocin, were divided into 5 groups, namely the diabetic control treated with vehicle (DC), standard control which received glibenclamide+metformin (SC), test groups treated with 100, 200and 400 mg/kg b.w. of Tinospora cordifolia (TC1, TC2 and TC3 respectively). A group of five normal animals served as normal control (NC). Fasting blood glucose, body weight and reaction time to tail flick were measured one week after induction of diabetes. The animals were then treated orally for two weeks after which the same parameters were repeated. In-vitro aldose reductase inhibition assay was carried out at concentrations of 5, 10, 25, 50, 100 and 200 mcg/ml of Tinospora cordifolia using rat lens from normal rats. The in-vivo results were analysed with Mann Whitney test.
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Three hundred and twenty nine diabetics (mean age 54- ± 8-year old) completed the study (162 metformin users, 167 nonusers). Compared with non-users, metformin users were used more often [38% vs 20%, P = 0.001]; had lower mean depression scores [6.8 vs 8.3; P = 0.026] and fewer comorbidities [1.5 vs 1.8, P = 0.022]. Adjusting for those three variables, pain scores were not significantly different between groups. In a subset analyses of those with neuropathic pain (n = 156), there were no differences in pain scores found between groups.
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Short-term continuous subcutaneous insulin infusion (CSII) in patients with newly diagnosed type 2 diabetes has been proved effective in improving metabolic control and β-cell function, thus inducing long-term drug-free remission. A randomized controlled trial was conducted to investigate whether CSII in combination with rosiglitazone, metformin, or α-lipoic acid separately brings about extra benefits.
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In this GCTA study, we obtained data about HbA1c concentrations before and during metformin treatment from patients in the Genetics of Diabetes Audit and Research in Tayside Scotland (GoDARTS) study, which includes a cohort of patients with type 2 diabetes and is linked to comprehensive clinical databases and genome-wide association study data. We applied the GCTA method to estimate heritability for four definitions of glycaemic response to metformin: absolute reduction in HbA1c; proportional reduction in HbA1c; adjusted reduction in HbA1c; and whether or not the target on-treatment HbA1c of less than 7% (53 mmol/mol) was achieved, with adjustment for baseline HbA1c and known clinical covariates. Chromosome-wise heritability estimation was used to obtain further information about the genetic architecture.
Targeted intervention had an effective role in improving lipid and BP profile in individuals with impaired glucose handling, with limited impact on glycaemia and no impact on weight. More work needs be done to evaluate the potential benefit of insulin sensitizing agents in this setting.
Our study first showed that treatment with both pioglitazone and basal insulin improved glycemic control, while only pioglitazone treatment was observed to be advantageous in terms of preserving renal function when used as an add-on therapy for patients with type 2 DM in whom sulfonylurea and metformin regimens failed.