Evaluation of Drug Interactions of Saxagliptin With Sildenafil in Healthy Volunteers
Diabetes MellitusType 22 morePatients with diabetes are three times more likely to develop erectile dysfunction (ED), and longer duration of diabetes is strongly associated with ED. The possibility of pharmacokinetic interactions may occur as the two drugs are metabolized by hepatic CYP3A4 and their co administration may affect their plasma concentrations. the aim of work is to investigate the effect of sildenafil a CYP3A4 substrate and inhibitor on the pharmacokinetics and safety of Saxagliptin, a CYP3A4 substrate Subjects and Methods: Eighteen healthy volunteers will be recruited in Sequential, single center study to determine pharmacokinetic parameters of Saxagliptin, and sildenafil,(AUC0→∞), (AUC0→t); Cmax; tmax; t½, k; ka) will be measured using validated LC-MS/MS method. Therapeutic doses will be given to volunteers as follows: Sildenafil 50 mg single dose on day 1, then washout period from day 2 till day 8. Saxagliptin 5 mg once/day will be given from day 9 till day 12, then on day 13 the two drugs will be co-administered. Blood samples (5ml) for pharmacokinetic analysis will be collected on days 1 and 13 for Sildenafil as well as on days 12 and 13 for Saxagliptin.
Impacts of Glucose Forecasting
Diabetes MellitusType 12 moreThis is a study of individuals with type I or type II diabetes. It is meant to test the effect of using the Diabits app on a participant's blood glucose control. The Diabits app is a diabetes management app which integrates with your continuous glucose monitor (CGM) and presents not only your current blood glucose trend, but also an estimate of your blood glucose values up to 60 minutes into the future. The Diabits app has been available in the USA and Canada for the past two years and was validated for predictive accuracy at BC Children's Hospital in Canada in 2017 with a predicted accuracy of 94.9%. Diabits app users in North America have shown some improvements in their individual time in range (TIR) and HbA1c values. This study aims to validate those results in a clinical setting. The study will randomise a total of 90 participants into using the Diabits app with or without the glucose forecasting enabled to help determine if the glucose forecasting (or predictions) can help participants make better treatment decisions and improve not only measurements of glucose such as time in range and HbA1c, but also reduce anxiety and improve quality of life with diabetes.
Orange Juice and Glycaemic Control in Type 2 Diabetes Mellitus
Diabetes MellitusType 2The evidence on the consumption of 100% orange juice in people with type 2 diabetes is highly variable and largely out-of-date, with a few studies reporting acute negative glycaemic effects when 100% orange juice is drunk with or without a meal. The aim of the project is to study the impact of the intake of a single serving of 100% orange juice on glycaemic control in male patients with pre-existing type 2 diabetes mellitus. In addition, immunological parameters and Alzheimer disease related biomarkers will be assessed to examine the chronic inflammatory state of these patients
Effectiveness of SCDM in Patients With Type 2 Diabetes
Type 2 DiabetesThis is a prospective, randomization, parallel, controlled study, which conducted to evaluate the effectiveness and related influencing factors of the Shared Care multidisciplinary diabetes care model. Patients with T2DM involved in the Shared Care model pay regularly quarterly visit to a multidisciplinary team led by physician at outpatient clinic, and receive remote and systematic management and education online after going home. After at least one year follow-up, evaluate the glycemic achieving rate (HbA1c<7%), the diabetes self-management behavior change and the effect of online diabetes self-management support for patients of the Shared Care multidisciplinary diabetes care model.
Diabetes Care Programme for Type 2 Diabetes Mellitus in Primary Care Setting
Diabetes MellitusType 2Uncontrolled metabolic parameters and co-morbidity risk factors cause Diabetes Mellitus as the leading cause of a multitude of micro-/macro-vascular complications. According to the International Guidelines and Recommendations, people with Type 2 Diabetes Mellitus (T2DM) should attend diabetes educational programmes periodically and optimize the metabolic index of control. In Hong Kong, General Practitioners with solo-practice (GP-SP) have the least availability of resources and support in DM management. A discrepancy of diabetes care between public and private settings and a gap of clinical practice between public-private healthcare settings is identified. In relation to the big population of T2DM is caring by GP-SP but no structured Diabetes Care Programme (DCP) is in place. A structured DCP for T2DM is in need to fill up the clinical gap and make beneficial to the target subjects. The aim of this study is to evaluate the effectiveness of a DCP for people with T2DM in primary care settings. It is a multi-center, single-blind randomized controlled trial with parallel groups pre-test and post-test design. The evidence-based intervention (DCP) will be carried out in a private primary care setting. People with T2DM attending the GP-SP who meet the study criteria will be randomly assigned into one of the two study groups, either "DCP in addition to usual medical care" or "Usual medical care only" as a control group. The intervention group can beneficial in clinical and psychosocial outcomes after the completion of the 20-week structured DCP with a greater improvement of HbA1c level, Self-Efficacy in diabetes management, Diabetes Empowerment level, Diabetes Knowledge, and Quality of Life than those who only received usual medical care at the GP-SP.
GLYPALCARE STUDY - Multicenter, Randomized Study for Evaluating Continuous Glucose Monitoring (CGM)...
Palliative CareDiabetes Mellitus9 moreCancer patients with known or newly diagnosed (i.e. iatrogenic) Diabetes Mellitus (DM) in Palliative/Supportive Care will be enrolled. Patients will be randomly assigned to one of two groups. Patients included in the first group will monitor glucose levels through Continuous Glucose Monitoring (CGM), using the FreeStyle Libre 2 (FSL2). The second group is represented by the usual standard way for blood glucose (BG) monitoring (lancing device for finger samples). An interim analysis is foreseen when the half of the expected events (hyperglycemic peaks) will be observed. In case the results of interim analysis show superiority of the CGM (FSL2) group patients of the second group will be switched.
Nutritional Intervention of Type II Diabetes Mellitus by Vitamin D in Qatar
Insulin ResistanceThere is an association between elevated Type II Diabetes Mellitus (T2DM) risk and low serum levels of vitamin D. It is important to examine whether Vitamin D can enhance oral glucose tolerance in individuals at risk for developing T2DM. As such, the hypothesis suggested is that Vitamin D supplementation (4,000 IU/day) for 24 weeks in pre-diabetic individuals will decrease insulin resistance and the associated metabolic indices linked to the later development of T2DM.
Lipid and Glycogen Metabolism in Patients With Impaired Glucose Tolerance and Calcium Sensing Receptor...
Type 2 Diabetes MellitusPrediabetes (Insulin Resistance4 moreBackground: Type 2 diabetes mellitus is a main risk factor for cardiovascular disease and heart failure, in part due to diabetic cardiomyopathy. However, the association between intracellular lipid accumulation and (myocardial) functional impairment is likely more complex than originally imagined. Recent studies suggest that not fat per se, but the content of saturated or unsaturated fatty acids might predict the development of cardiac steatosis and myocardial dysfunction. In addition skeletal muscle and hepatic glycogen metabolism is impaired in patients with diabetes mellitus. Data from animal experiments suggest a relevant role of myocardial glycogen stores in ischemic preconditioning. Due to methodological limitations so far data on myocardial glycogen stores and myocardial lipid composition in humans are missing. Hypothesis: In addition to total ectopic lipid deposition in the myocardium, myocardial lipid composition, i.e. the relative abundance of saturated and unsaturated fatty acids, and impaired myocardial glycogen metabolism may play an important role in the development cardiac lipotoxicity leading to diabetic cardiomyopathy. Pancreatic endocrine function and myocardial morphology and function is altered in patients with heterozygote inactivating mutations of the CaSR-gene / FHH. Aims: Metabolic virtual biopsy of the myocardium for identification of specific patterns of intracellular lipid composition and myocardial glycogen metabolism as possible critical determinants of metabolic cardiomyopathy Characterization of the metabolic interplay between the myocardium, skeletal muscle, liver and adipose tissues in different stages of development of type 2 diabetes compared to patients with calcium sensing receptor mutation Methods: 1H/13C and 31P magnetic resonance spectroscopy and imaging for measurements of myocardial, skeletal and liver lipid and glycogen content, abdominal adipose tissue distribution and composition, ATP synthesis and myocardial functional parameters Mixed meal tolerance tests to trace the postprandial partitioning of substrates between insulin sensitive tissues (myocardium, skeletal muscle, liver, adipose tissue). Hyperinsulinemic-hyperglycemic glucose clamp (HHC) with enrichment of the infused glucose with the stable isotope [1-13C]glucose to trace the incorporation of circulating glucose into myocardial glycogen in healthy insulin sensitive volunteers, prediabetic insulin resistant volunteers with impaired glucose tolerance, healthy subjects, patients suffering from type 2 diabetes mellitus, patients suffering from type 1 diabetes and patients with heterozygote mutation in calcium sensing receptor.
Web-Based Collaborative Care for Patients With Diabetes and Depression
Diabetes MellitusType 21 moreThe goal of this proposal is to integrate depression services and diabetes care methods into a web-based collaborative care system so that a single program can assist patients with diabetes and co-morbid depression. The investigators hypothesized that the effect of the intervention program on (a) decreasing depressive symptomatology; (b) improving biomedical outcomes (e.g., blood lipid profiles,blood glucose, glycosylated hemoglobin, and blood pressure). (c) Increasing healthful behavior (medicine compliance, physical activity, diabetic diet);(d)decreasing unhealthful behavior( sedentary activities, smoking, alcohol addiction); (e) improving quality of life.
Self-monitoring of Blood Glucose in Insulin-treated Patients With Type 2 Diabetes
Diabetes MellitusType 2Primary Objective: The objective of the study is to investigate the effect of a specific frequency of Self-monitoring of blood glucose (SMBG) on glycemic control and quality of life in patients with type 2 diabetes and who are in stable good glycemic control and using 1 insulin injection daily. The research question is: Does a less intensive frequency of SMBG in insulin-treated patients with type 2 diabetes, who are in stable good glycemic control, using 1 insulin injection daily, lead to a clinically relevant increase of HbA1c (an increase of 0.5%) and what is the effect on quality of life? Secondary objectives: The secondary objectives is to investigate the effect of a specific frequency of SMBG on the number of hypo and hyper glycaemia, number of extra diabetes-related contacts with the health care provider, and the diabetes medication.