scholarly journals Effect of a New Formulation of Nutraceuticals as an Add-On to Metformin Monotherapy for Patients with Type 2 Diabetes and Suboptimal Glycemic Control: A Randomized Controlled Trial

Nutrients ◽  
2021 ◽  
Vol 13 (7) ◽  
pp. 2373
Author(s):  
Giovanni Sartore ◽  
Eugenio Ragazzi ◽  
Giulia Antonello ◽  
Chiara Cosma ◽  
Annunziata Lapolla

The aim of the study was to evaluate the overall biohumoral and metabolic effects of a 12-week add-on therapy consisting of a new nutraceutical formulation (BHC) based on berberine, hesperidin, and chromium picolinate in type 2 diabetes mellitus (T2D) patients with suboptimal glycemic compensation receiving metformin. After 12 weeks, participants in the group receiving metformin plus BHC, compared to the group receiving metformin only, saw a significant improvement in their glucose profile, in terms of both glycated hemoglobin (HbA1c) and fasting blood glucose (FBG). Their FBG dropped from 145 ± 20 mg/dL to 128 ± 23 mg/dL (p < 0.01), a decrease of 11.7% compared with the baseline. This decrease differed significantly from the situation in the control arm (p < 0.05). HbA1c decreased by 7.5% from the baseline, from 53.5 ± 4.3 mmol/mol to 49.5 ± 5.1 mmol/mol (p < 0.01), in the group given BHC, while no difference was seen in the control group. Advanced glycation end products (AGEs) and malondialdehyde (MDA) were found to be significantly reduced (p < 0.01) only in the BHC group, from 9.34 ± 7.61 μg/mL to 6.75 ± 6.13 μg/mL, and from 1.7 ± 0.15 μmol/L to 1.4 ± 0.25 μmol/L, respectively. In patients with T2D taking metformin with suboptimal glycemic compensation, adding BHC for 3 months significantly improved glucose control in terms of FBG and HbA1c, and had a positive effect on the lipid peroxidation profile, as indicated by a decrease in AGEs and MDA.

Author(s):  
K. Wernicke ◽  
J. Grischke ◽  
M. Stiesch ◽  
S. Zeissler ◽  
K. Krüger ◽  
...  

Abstract Objectives The aim was to investigate the effect of physical activity on periodontal health and HbA1c levels in patients with type 2 diabetes mellitus (T2DM) over a period of 6 months. Materials and methods Thirty-seven patients with non-insulin-dependent T2DM were included in the study. The intervention group (n=20) performed physical activity over a period of 6 months. The control group (n=17) did not receive any intervention. Baseline and final examinations included dental parameters and concentrations of glycosylated hemoglobin (HbA1c) and high-sensitivity C-reactive protein (hsCRP). Results Physical activity showed a positive effect on periodontal health. Both the BOP (p= 0.005) and the severity of periodontitis (p= 0.001) were significantly reduced in the intervention group compared to the control group. Furthermore, HbA1c levels were reduced (p= 0.010) significantly in the intervention group while hsCRP levels significantly increased in the control group (p= 0.04). Conclusions Within the limitations of this randomized, controlled trial, physical activity over a period of 6 months is a health-promoting measure for patients with T2DM and improves both periodontal health and HbA1c concentrations.


2021 ◽  
Author(s):  
◽  
Julio Cesar Loya

Limited information is available regarding culturally-tailored physical activity (PA) interventions for Hispanic adults with type 2 diabetes mellitus (T2DM). A community-partnered approach was used to examine a novel culturally-tailored PA intervention using a pre-post, no control group design. The intervention consisted of six weekly 45-minute sessions for participants to engage in PA led by the researcher. A total of 21 individuals participated in the study. The typical participant was a 53-year-old female (90 percent) Hispanic adult living with T2DM with low acculturation. On average, before the intervention, the participants walked 10,285 (sd 14,779) steps per week with 43.4 (sd 68.1) minutes of PA per week. Despite implementation during the COVID-19 pandemic, the intervention was feasible and acceptable, and 19 (90.5 percent) participants attended all intervention sessions. There were significant increases in steps per week (p=0.007; d=1.03) and minutes of PA per week (p=0.000; d=1.62). Findings suggest that Salud Paso por Paso has promise as a strategy to enhance PA behaviors in the priority population. A randomized, controlled trial with a larger study sample is warranted to examine efficacy and impact on the diabetes health outcomes of Hispanic adults with T2DM.


2020 ◽  
Author(s):  
Xiaomeng Sun ◽  
Jia Liu ◽  
Guang Wang

Abstract Background: This study was to research the efficacy of fenofibrate in the treatment of microalbuminuria in the patients with type 2 diabetes mellitus (T2DM) and hypertriglyceridemia. Methods: Type 2 diabetic patients (56) with microalbuminuria and hypertriglyceridemia aged 30 to 75 were randomly divided into the fenofibrate treatment group(n=28) and the control group (n=28) for 180 days. Urinary microalbumin /creatinine ratio (UACR) and other metabolic parameters were compared at baseline, during treatment and after treatment. Results: After 180 days, the reduction of levels of fasting blood glucose (FBG) and glycosylated hemoglobin (HbA1c) in two groups were no differences. In treatment group, uric acid (UA) (296.42 ± 56.41 vs 372.46 ± 72.78), triglyceride (TG) [1.51(1.17, 2.06) vs 3.04(2.21, 3.29)], and UACR [36.45 (15.78,102.41) vs 129.00 (53.00, 226.25)] were significantly decreased compared with the baseline. The high-density lipoprotein cholesterol (HDL-C) levels were significantly increased (1.22 ± 0.26 vs 1.09 ± 0.24) compared with the baseline. The decrease in UACR [-44.05(-179.47, -12.16) vs -8.15(-59.69, 41.94)]in treatment group was significantly higher compared with the control group. The decrease in UACR was positively associated with the decreases in TG ( r = 0.447, P = 0.042) and UA ( r = 0.478, P = 0.024) after fenofibrate treatment. Conclusion: In the patients with hypertriglyceridemia and type 2 diabetes mellitus, fenofibrate can improve microalbuminuria and do not increase the deterioration of glomerular filtration rate


2015 ◽  
Vol 3 (1) ◽  
pp. 36-45 ◽  
Author(s):  
Perceval Singh ◽  
Cliff K Riley ◽  
Andrew Wheatley ◽  
Michael Boyne ◽  
Errol Morrison ◽  
...  

This study focused on the effect of consumption of indigenous Caribbean foods with low and intermediate glycemic index (GI) high fiber contents on glycated haemoglobin (A1c), insulin, fasting blood glucose, homocysteine (tHCY), high sensitivity C-reactive protein (hs-CRP), HOMA-IR and lipoprotein profile levels in overweight persons with type 2 diabetes. The methodology followed a randomized controlled parallel design, which compared two dietary treatment modalities in adult Jamaicans who were overweight and diagnosed with type 2 diabetes (mean age 42.5 ± 2.0 years, 55% females, mean A1c 9.30 ± 0.56%) over six months. The intervention group (n=32) underlined the consumption of low-intermediate-GI foods, whereas the control group (n = 33) were not so advised and consumed a high-GI diet. Attempts were made to ensure that both groups were isocaloric with 45-50% of energy from carbohydrates. Consumption of low-intermediate GI foods resulted in significant reductions (p<0.005) in A1C compared to participants who consumed high GI foods (-0.84 ± 0.26 vs. -0.35 ± 0.04%), hs-CRP (-0.52 ± 0.17 vs. -0.17 ± 0.31 mg/dL) and tHCY (-1.32 ± 0.39 vs. -0.59 ± 0.38 µmol/L). Insulin sensitivity, HDL-C and triglycerides significantly improved in participants who consumed the low-intermediate-GI diet. The data strengthen the metabolic benefits of meal plans that emphasize the consumption of low and intermediate GI high fiber foods, particularly, indigenous Caribbean complex starchy foods.


Author(s):  
Samar F. Miski ◽  
Mai A. Alim A. Sattar Ahmad ◽  
Ahmed Esmat

Aim: To determine the potential hepatoprotective effect of Agmatine (AGM) on NAFLD-induced by Type 2 diabetes mellitus (T2DM) in rats. Study design:  Forty male Wistar rats weighing from (200 -250 g) were distributed at random into five groups (8 rats per group): group 1 as control; group 2 as untreated-T2DM; groups 3 & 4 as T2DM cotreated with AGM (40 & 80 mg/kg/d), while group 5 T2DM cotreated with Silymarin (100 mg/kg/d). Place and duration of study: Department of Pharmacology, Faculty of Medicine, king Abdul-Aziz University; between October 2020 and January 2021. Methodology: A rat model of T2DM with NAFLD complication was established by feeding rats with 10% fructose in drinking water and intraperitoneally injecting them with a single low dose of streptozotocin (STZ) (45mg/kg). The fasting blood glucose was detected, serum levels of hepatic biomarkers were all assessed. Moreover, histopathological examination was performed by hematoxylin and eosin (H&E) staining. Results: STZ induced T2DM in rats causes a significant (p<0.05, n=8) rise in serum levels of FBG, ALT, AST, TB, TC, TG, and LDL in comparison with the corresponding control group. Co-treatment with AGM (40 & 80 mg/kg) and silymarin significantly alleviated hyperglycemia and amended hepatic biomarkers that was reflected on improved histopathological changes. Conclusion: The current data suggest that oral AGM co-treatment could have a hepatoprotective effect against T2DM associated with NAFLD in rats. Further investigations are recommended to elucidate molecular mechanisms accountable for the useful effects of AGM on hepatocytes.


2021 ◽  
pp. 20-22
Author(s):  
Shajahan Shajahan ◽  
Koneru Sri Lahari ◽  
P. Kiranmai

BACKGROUND:Type 2 Diabetes Mellitus is a major non-communicable disease resulting from insulin resistance and is associated with cardiovascular,neurological and renal complications.Recent studies show association of hyperuricemia and Diabetes Mellitus.Uric acid increases oxidative stress that leads to vascular dysfunction and high intra glomerular pressure leading to renal complications.High serum creatinine is an indicator of renal compromise. OBJECTIVES: To evaluate serum uric acid and serum creatinine levels in type 2 diabetes mellitus patients and to find association between them. METHODOLOGY: The study was conducted in Osmania general hospital. Fifty cases of established Type 2 Diabetes Mellitus formed the study group and 50 normal healthy individuals formed the control group. Serum uric acid, Fasting Blood Glucose (FBS) and serum creatinine were estimated by colorimetric enzymatic methods on Beckman coulter AU5800.Mean values were compared in cases and controls using student t- test.Study group was further studied under 2 subgroups with serum Uric acid < 7 mg/dl and ≥7 mg/dl.In these 2 subgroups the association of Serum uric acid with FBS and creatinine was analysed statistically. RESULTS: Serum uric acid were found high in cases(7.63+/- 3.36)as compared to controls(4.48+/- 1.09) p value < 0.001.Serum creatinine were also high in cases(1.59+/- 1.39 )as compared to controls ( 0.87+/- 0.29) p value <0.005.Study subgroup with serum uric acid ≥7 mg/dl was associated with high creatinine and high fasting blood sugar levels when compared to subgroup with serum uric acid <7 mg/dl. CONCLUSION: Our study showed increased serum uric acid and serum creatinine levels in cases when compared to controls.There was significant association between high serum uric acid and high creatinine levels in cases.Therefore,it is important to measure serum uric acid and serum creatinine levels in diabetics for early detection of renal pathology.


2021 ◽  
Author(s):  
Lucija Gosak ◽  
Majda Pajnkihar ◽  
Gregor Štiglic

BACKGROUND Chronic diseases are an important public health issue worldwide and affect an individual's quality of life. Due to the alarming rise in type 2 diabetes, healthcare, which was previously largely focused primarily on diagnosis and treatment of the disease, is increasingly focused on prevention and self-care. Patients who adhere to a constant and strict treatment regimen (physical activity, diet, medication) and regularly monitor their health, maintain self-care and health, prevent exacerbation of the disease and prevent complications of diabetes (retinopathy, diabetic feet). Many innovative devices that have become increasingly present in patient health care in recent years, such as mobile applications, are available to patients to maintain consistency in monitoring their health status. Mobile applications make it easier for individuals to monitor their self-care, monitor illness, and make it easier to follow instructions regarding disease control. OBJECTIVE The study aim is to determine the impact of mobile application use on self-care in patients with type 2 diabetes. The aim of the study is also to evaluate and test the usefulness of the forDiabetes application as a tool to improve the self-care of individuals with type 2 diabetes. METHODS We will perform a double-blind randomized controlled trial. The study will include individuals over the age of 18 who have been diagnosed and have regulated type 2 diabetes, who have already received oral treatment and are being treated in family medicine practice. Also, individuals included in the study should not have any acute complications due to the consequences of type 2 diabetes. During the study, they should be able to use an Android or iOS mobile phone and a blood glucose meter. With the help of simple randomization, individuals will be divided into an intervention and a control group. Individuals in the intervention group will use the forDiabetes mobile app to monitor their self-care for type 2 diabetes. Individuals in the control group will not receive a special intervention. Data will be collected using the “Self-care of Diabetes Inventory” questionnaire and a “Brief Illness Perception Questionnaire”. Blood sugar, blood pressure, HbA1c, and weight measurements will be monitored using the calibrated instruments during the study by the nurses employed in family medicine practice. Data will be collected at the beginning of the study and after the patient visit to the family medicine practice. RESULTS The expected results as a result of using the mobile application forDiabetes are the impact on the level of self-care, the impact on the perception of the disease, blood sugar levels, blood pressure, HbA1c, and the measured body weight of the patient. CONCLUSIONS The research contributes to greater visibility and usability of mobile applications for self-care of patients with type 2 diabetes and makes aware of the possible use of innovative methods. CLINICALTRIAL NCT04999189


2018 ◽  
Vol 39 (2) ◽  
pp. 109-117
Author(s):  
Seyed Mohammad Mehdi Hazavehei ◽  
Sahar Khoshravesh ◽  
Zahra Taheri-Kharameh

Background One of the most common problems that the elderly with chronic diseases, especially diabetes, faces is lack or poor medical adherence. The aim of this study was to determine the effect of interventions in increasing medical adherence in the elderly with type 2 diabetes. Methods The databases of Cochrane, Embase, PubMed, Scopus, Science Direct, and web of science were searched until April 2017 free from time and language limitation. In review, only randomized controlled trial (RCT) design studies were investigated. The studies of interest were evaluated from three perspectives: educational intervention with or without theories/models of health education and promotion, educational intervention (individual or group education), and noneducational intervention to increase medical adherence. The qualification of RCTs was evaluated through Cochrane Collaboration Risk of Bias Tool. Results Finally, five studies were considered in this systematic review. Educational interventions were used in all of the studies, and in three of these studies, noneducational interventions such as support group, psychiatric consultation, and phone consultation were implemented along with educational intervention. In all studies, medical adherence in the intervention group increased when compared with the control group or basic conditions ( p < .05). All RCTs had high risk of bias. Conclusion This review provides evidence which must be considered in the elderly with diabetes a combination of the educational and noneducational methods to increase medical adherence. It is necessary to conduct studies with higher quality to assess the efficacy of interventions.


2019 ◽  
Vol 2019 ◽  
pp. 1-7 ◽  
Author(s):  
Fan Zheng ◽  
Suixin Liu ◽  
Yuan Liu ◽  
Lihua Deng

Objective. This study is aimed at assessing the effectiveness of a simple outpatient diabetes self-management education programme. Methods. In the study, 60 patients with type 2 diabetes mellitus were randomly allocated into the control group (n=30) and intervention group (n=30). Regular and 2-session health education programmes were provided. The summary of diabetes self-care activity measure, problem areas in the diabetes scale, fasting blood glucose, postprandial 2 h blood glucose, and HbA1c were measured before and after the intervention to assess the effects of this 2-session diabetes education programme. Results. The total mean score of the summary of diabetes self-care activities measure was 17.60±6.63 points. The problem areas in the diabetes scale revealed that the total mean score was 29.82±15.22 points; 27% of the patients had diabetes-related distress, while 9% suffered from severe emotional distress. Compared with the control group, scores of the summary of diabetes self-care activities measure and problem areas in the diabetes scale, fasting blood glucose, postprandial 2 h blood glucose, and HbA1c were significantly improved in the intervention group after the intervention (P<0.01). Conclusion. This study showed that the 2-session diabetes education programme could effectively improve the level of self-reported self-management, psychological distress, and glycemic control in patients with type 2 diabetes mellitus.


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