scholarly journals A randomized, double-blind clinical trial of a herbal formulation (GlycaCare-II) for the management of type 2 diabetes in comparison with metformin

2021 ◽  
Vol 13 (1) ◽  
Author(s):  
Muhammed Majeed ◽  
Anju Majeed ◽  
Kalyanam Nagabhusahnam ◽  
Lakshmi Mundkur ◽  
Shaji Paulose

Abstract Background Type 2 diabetes mellitus (T2DM) is a major public health concern with growing prevalence with multiple debilitating complications. GlycaCare-II is a proprietary herbal formulation supplement for T2DM containing extracts of Cinnamomum cassia, Momordica charantia, Pterocarpus marsupium, Gymnema sylvestre, Salacia reticulata, Eugenia jambolana, and a bioavailability enhancer piperine from Piper nigrum. Objective The antihyperglycemic potential of GlycaCare-II was compared against metformin in a double-blind study. Design It was a randomized, two-arm design on prediabetic (N = 29; 12 in metformin and 17 in GlycaCare-II arm, respectively) and newly diagnosed diabetic (N = 40; 16 in metformin and 24 in GlycaCare-II) patients for 120 days. Outcome measures Changes in diabetic panel glycosylated hemoglobin (HbA1c), fasting blood sugar (FBS), and postprandial blood sugar (PBS) were the primary endpoints. Lipid profile, liver profile, thyroid-stimulating hormone, bilirubin and creatinine were the secondary endpoints. Result Twice a day treatment for 120 days with GlycaCare-II led to a statistically significant change in HbA1c (p < 0.001), FBS (p < 0.001), PBS (p < 0.001) on both prediabetic and newly diagnosed diabetic patients. GlycaCare-II showed a similar potential as metformin in the treatment of T2DM. In the prediabetic group, both GlycaCare-II and metformin were comparable for all the hyperglycemic index parameters. In the case of newly diagnosed diabetic patients, GlycaCare-II showed a significantly better reduction for PBS (p = 0.026) as compared to metformin, while all other parameters in the diabetic panel were comparable. No adverse events were reported throughout the trial period. Conclusion These results suggest that GlycaCare-II is effective in managing T2DM in both newly diagnosed diabetic and prediabetic patients.

Author(s):  
Shah Namrata Vinubhai ◽  
Pardeep Agarwal ◽  
Bushra Fiza ◽  
Ramkishan Jat

Background: Serum ferritin is known as an index for body iron stores also as an inflammatory marker and it is influenced by several disease. We were looking for a correlation between HbA1c and S. Ferritin in type 2 DM. Methodology: The present study a total of 150 participants were enrolled of which 100 were confirmed cases of Type 2 Diabetes Mellitus and rest 50 age and sex matched healthy subjects constituted the control group. All were screened for HbA1c, Fasting blood sugar, Post prandial blood sugar and S.Ferritin. Results: A highly significant variation and positive correlation was observed with respect to S.Ferritin and HbA1c levels. Mean S.Ferritin was high in the subgroup with poor glycemic control. Conclusion: The fasting, post prandial sugar levels, HbA1c and S.Ferritin were significantly higher in the diabetic subjects. This study shows a positive correlation between HbA1c and S. Ferritin levels. So we can conclude that in diabetic patients S. Ferritin may serve as an independent marker of poor glycemic and metabolic control. Keywords: Serum ferritin, Type 2 Diabetes Mellitus, HbA1c.


2006 ◽  
Vol 290 (1) ◽  
pp. E54-E59 ◽  
Author(s):  
Lucilla D. Monti ◽  
Emanuela Setola ◽  
Gabriele Fragasso ◽  
Riccardo P. Camisasca ◽  
Pietro Lucotti ◽  
...  

The aim of the present study was to evaluate the effect of prolonged inhibition of β-oxidation on glucose and lipid muscle forearm metabolism and cGMP and endothelin-1 forearm release in patients with type 2 diabetes mellitus and ischemic cardiomyopathy. Fifteen patients were randomly allocated in a double-blind cross-over parallel study with trimetazidine (20 mg tid) or placebo lasting 15 days. At the end of each period, all patients underwent euglycemic hyperinsulinemic clamps with forearm indirect calorimetry and endothelial balance of vasodilator and vasoconstricor factors. Compared with placebo, trimetazidine induced 1) an increase in insulin-induced forearm glucose uptake and glucose oxidation accompained by a reduction in forearm lipid oxidation and citrate release and 2) a decrease of endothelin-1 release paralleled by a significant increase in forearm cGMP release. Forearm glucose oxidation significantly correlated with cGMP release ( r = 0.37, P < 0.04), whereas forearm lipid oxidation positively correlated with endothelin-1 release ( r = 0.40, P < 0.03). In conclusion, for the first time, we demonstrated that insulin-induced forearm glucose oxidation and forearm cGMP release were increased whereas forearm endothelin-1 release was decreased during trimetazidine treatment. Muscle's metabolic and vascular effects of trimetazidine add new interest in the use of trimetazidine in type 2 diabetic patients with cardiovascular disease.


Author(s):  
Yangyang Cheng ◽  
Xiaohui Du ◽  
Bilin Zhang ◽  
Junxia Zhang

Abstract Background Serum wnt1-induced signaling pathway protein 1 (WISP1) levels are increased with obesity, which is a common complication associated with lower extremity atherosclerotic disease (LEAD). However, to date, the relationship between elevated WISP1 levels and the incidence of lower extremity atherosclerotic disease (LEAD) in type 2 diabetes mellitus (T2DM) remains unclear. Methods 174 newly diagnosed type 2 diabetic patients were enrolled in our study. Patients were divided into two groups, LEAD group (n=100) and control group (n=74). Anthropometric parameters, blood pressure and some biochemical parameters were obtained. Body composition was detected by bioelectrical impedance analysis (BIA). Levels of serum insulin were determined by radioimmunoassay. Serum WISP1 and interleukin 6 (IL-6) levels were determined using an enzyme-linked immunosorbent assay. Results It was shown that serum WISP1 levels in diabetic patients with LEAD were higher than those without LEAD (P<0.001). Serum WISP1 levels were positively related with waist circumference (r=0.237, P=0.003), waist-hip ratio (r=0.22, P=0.006), visceral fat area (r=0.354, P<0.001), serum creatinine (r=0.192, P=0.012), interleukin 6 (r=0.182, P=0.032), c-reactive protein (r=0.681, P<0.001), triglycerides (r=0.119, P<0.001), fasting glucose (r=0.196, P=0.011), glycated hemoglobin (r=0.284, P<0.001), and HOMA-IR (r=0.285, P<0.026). Compared with the lowest tertile, the odds ratio of the middle tertile for LEAD incidence was 3.27 (95% CI, 1.24–8.64) and 4.46 (95% CI, 1.62–12.29) for the highest tertile after adjusting confounding factors. Conclusion The results suggest that increased serum WISP1 levels independently contribute to the incidence of LEAD in patients with newly diagnosed T2DM.


2005 ◽  
Vol 75 (5) ◽  
pp. 307-311
Author(s):  
Sakuta ◽  
Suzuki ◽  
Yasuda ◽  
Ito

Limited data suggest that folate levels are higher in patients with type 2 diabetes than in subjects with normal glucose tolerance (NGT). We compared the fasting plasma folate, glucose (FPG), body mass index (BMI), and supplementary vitamin use among male subjects with NGT, those with impaired glucose tolerance (IGT), those with newly diagnosed type 2 diabetes, and those with previously diagnosed type 2 diabetes. Plasma folate of patients with newly diagnosed diabetes and that of patients with previously diagnosed diabetes was significantly higher than that of NGT subjects (p < 0.001). Prevalence of vitamin use was lower in newly diagnosed or previously diagnosed diabetic patients compared with non-diabetic subjects. Self-rated vegetable intake was similar among the four groups. FPG, BMI, triglycerides, and systolic blood pressure correlated with plasma folate levels independently of lifestyle factors studied. These results suggest that plasma folate levels are elevated in male diabetic patients independently of health-conscious behavior that is recommended for diabetic people.


2018 ◽  
Vol 5 (2) ◽  
pp. 424
Author(s):  
Pradeep V. Gadge ◽  
Roshani P. Gadge ◽  
Nikita D. Paralkar

Background: Teneligliptin was recently approved for type 2 diabetes (T2D) management in India and is used as monotherapy or in combination with different antidiabetic drugs. The aim of this study was to identify patients’ characteristics associated with better glycemic response to teneligliptin and metformin.Methods: A retrospective analysis of data was performed in patients of T2D with HbA1c above 7% who were treated with teneligliptin 20 mg/d as add on to metformin (500-100 mg/d) and whose follow-up data at 12-weeks was available. Fasting blood sugar (FBS) and post-prandial blood sugar (PPBS) changes were analysed.  Results: Among 66 patients included in analysis, mean age was 61.0±9.8 years and 53% were females. Median duration of diabetes was 2 years. At 12-weeks, a significant reduction PPBS was observed (mean change: -14.3 mg/dL, p=0.009) but not in FBS (mean change: -2.4 mg/dL, p=0.353). Among different patients’ characteristics, age ≤60 years (p=0.006), duration of ≤1 year (p=0.023), body-mass index ≥25 kg/m2 (p=0.009), presence of dyslipidemia (p=0.05) and absence of complications (p=0.012) were associated with significant reduction in PPBS but not in FBS.Conclusions: A younger, newly-diagnosed, obese T2D patients with dyslipidemia without any complications of diabetes can derive better therapeutic effectiveness from teneligliptin added to metformin. These findings need to be confirmed in large, prospective, long duration study.  


2008 ◽  
Vol 93 (10) ◽  
pp. 3839-3846 ◽  
Author(s):  
Thomas Linn ◽  
Britta Fischer ◽  
Nedim Soydan ◽  
Michael Eckhard ◽  
Julia Ehl ◽  
...  

Aims/Hypothesis: Insulin glargine is a long-acting human insulin analog often administered at bedtime to patients with type 2 diabetes. It reduces fasting blood glucose levels more efficiently and with less nocturnal hypoglycemic events compared with human neutral protamine Hagedorn (NPH) insulin. Therefore, bedtime injections of insulin glargine and NPH insulin were compared overnight and in the morning. Methods: In 10 type 2 diabetic patients, euglycemic clamps were performed, including [6,6′]2H2 glucose, to study the rate of disappearance (Rd) and endogenous production (EGP) of glucose during the night. On separate days at bedtime (2200 h), patients received a sc injection of insulin glargine, NPH insulin, or saline in a randomized, double-blind fashion. Results: Similar doses of both insulins had different metabolic profiles. NPH insulin had a greater effect on both Rd and EGP in the night compared with insulin glargine. By contrast, in the morning, insulin glargine was more effective, increasing Rd by 5.8 μmol/kg−1·min−1 (95% confidence interval 4.7–6.9) and reducing EGP −5.7 (−5.0 to −6.4) compared with NPH insulin. Nearly 80% of the glucose lowering effect in the morning was due to insulin glargine’s reduction of EGP. Its injection was associated with one-third lower morning glucagon levels compared with NPH insulin (P = 0.021). Conclusion/Interpretation: Nocturnal variations of EGP and Rd explain the reduced incidence of hypoglycemia and lower fasting glucose levels reported for insulin glargine compared with human NPH insulin.


2015 ◽  
Vol 7 (1) ◽  
pp. 26-32
Author(s):  
R Thapa ◽  
S Bajimaya ◽  
S Sharma ◽  
B B Rai ◽  
G Paudyal

Introduction: Proliferative diabetic retinopathy (PDR) is the leading cause of blindness among the diabetics. Objective: to study the systemic association of proliferative diabetic retinopathy. Materials and methods: A prospective, case-series study was conducted among the newly diagnosed proliferative diabetic retinopathy cases presenting at the Tilganga Institute of Ophthalmology (TIO) from January 2012 to January 2013. Diabetic retinopathy was classi¿ed using the Early Treatment Diabetic Retinopathy Study criteria. Blood pressure, fasting and postprandial blood sugar, glycosylated hemoglobin, lipid pro¿le, urine for microalbumin, urea, and creatinine were evaluated at the time of diagnosis.Results: A total of 104 type 2 diabetic patients with newly diagnosed PDR presented during the study period. Concurrent macular edema was present in 93 cases (89.42 %). The mean age was 56.96 ± 9.394 (range 32 - 78) years. Males and females comprised of 75.7 % and 24.3 % respectively. The majority (37.5 %) were involved in business, followed by government service (17.30 %), and housewives (16.34 %). Mean duration of diabetes was 11.42 ± 5.356 years (range 1 month - 26 years). Concurrent hypertension was found in 55.76 %, uncontrolled fasting and or postprandial blood sugar in 72.54 %, poor glycemic control (HbA1C > 7 %) in 73.97 %, abnormal lipid profile in 52.56 %, microalbuminuria in 67.85 %, and positive urine albumin in 50 % of the cases.Conclusion: Despite the short duration of diabetes, the concurrent hypertension, poor glycemic control, proteinuria and dyslipidemia were the main systemic associations for PDR at our clinical set-up. Awareness, identification and management of these systemic problems could reduce the rapid progression to PDR.


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