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Diabetes Mellitus, Type 2 clinical trials

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NCT ID: NCT03274089 Recruiting - Hypertension Clinical Trials

Health Outcomes of Patients With Stable Chronic Disease Managed With a Healthcare Kiosk

Start date: June 21, 2018
Phase: N/A
Study type: Interventional

The chronic disease burden is increasing worldwide leading to a rise in the demand for primary healthcare and a shortage of primary care physicians. Addressing this shortage entails a multi-prong approach with innovations in care delivery, greater use of healthcare technology, and more efficient use of all healthcare providers on the care team. We previously developed an interactive self-service healthcare kiosk (Self-empowering and enabling kiosk - SEEK® MyHealthKiosk) for the management of patients with stable chronic disease in the primary care setting. A feasibility study using SEEK showed high levels of acceptance and satisfaction from patients and healthcare providers. The aim of this follow-up study is to evaluate the health outcomes of patients with stable chronic disease who are on kiosk management compared to patients who are on routine management by nurse clinicians. We hypothesize that patients who are managed by the kiosk continue to maintain good disease control that are comparable to patients who are managed by a nurse clinician.

NCT ID: NCT03267758 Recruiting - Clinical trials for Diabetes Mellitus, Type 2

Effect of Probiotic Supplementation on Endothelial Function II

Start date: May 15, 2018
Phase: N/A
Study type: Interventional

Researchers at MCW have discovered a new pathway that links the type of bacteria present in the intestines to the severity of heart attacks. This discovery of a relationship between intestinal bacteria, bacterial metabolites, and severity of heart attacks means that for the first time, the investigators may be able to determine a person's probability of having a heart attack via non-conventional risk factors. This may provide opportunities for novel diagnostic tests as well as a potential for therapeutic intervention. The link between gut microbiota and the severity of heart attacks may also lead to novel therapeutic approaches (probiotics, non-absorbable antibiotics) to prevent heart attacks from happening. The studies proposed will test the hypothesis that altered intestinal microbiota are mechanistically linked to the pathogenesis of cardiovascular disease. The investigator's objective is to determine whether inflammatory markers in the blood are decreased and endothelial cell function improved by a probiotic in patients with established coronary artery disease. Furthermore, the investigators wish to elucidate a mechanism by which the gut microbiota regulates serum inflammatory markers. 1. Specific Aim 1 will determine the impact of a probiotic on circulating leptin and TMAO levels, conventional risk factors for cardiovascular disease and diabetes (total cholesterol, LDL cholesterol, oxidized LDL, triglycerides, C-reactive protein, serum amyloid A, fibrinogen and adiponectin, glucose-dependent- insulinotropic polypeptide (GIP), glucagon-like-peptide (GLP-1), glucagon, insulin), and their relationship to the intestinal microbiota (15 representative microbial groups) as non conventional risk factors. Several blood samples will be collected to measure biomarkers. Participants will provide periodic stool samples in order to measure gut bacterial biodiversity. Lastly, endothelial cell function (flow mediated dilation) will be measured in order to assess blood vessel function. 2. Specific Aim 2 will determine the impact of a probiotic on metabolites derived from the intestinal microbiota as candidates for non-conventional risk factors of cardiovascular disease. The relationship between metabolites derived from the intestinal microbiota, endothelial cell function and risk factors for cardiovascular disease identified in Specific Aim 1 will be correlated.

NCT ID: NCT03264352 Recruiting - Clinical trials for Diabetes Mellitus, Type 2

Intervention for High-normal Blood Pressure in Adults With Type 2 Diabetes

IPAD
Start date: February 1, 2018
Phase: Phase 4
Study type: Interventional

Lowering of blood pressure (BP) in high-risk hypertensive individuals reduces major adverse cardiovascular and cerebrovascular events. Diabetic patients with hypertension benefit from BP lowering treatment. The present trial, IPAD in brief, is a randomized, open-label, parallel-designed, multicenter study involving nearly 12,000 patients to be recruited and to be followed up for a median of four years. IPAD tests the hypothesis that antihypertensive medications in adults with type 2 diabetes, whose seated BP 120-139 mm Hg systolic and below 90 mm Hg diastolic, results in 20% difference in the incidence of major adverse cardiovascular and cerebrovascular events. During follow-up for participants in the intensive group, the sitting systolic pressure should be decreased to below 120 mm Hg, by titration and combination of the study medications of an angiotensin type-1 receptor blocker Allisartan (240 mg/day), a dihydropyridine calcium-channel blocker (amlodipine 5-10 mg/day), and/or other medications if necessary. For those in the standard group, the sitting systolic pressure should be monitored and controlled below 140 mm Hg.

NCT ID: NCT03254446 Recruiting - Hypertension Clinical Trials

Safety and Efficacy Study of TRC150094 to Improve the CV Risk in Subjects With Diabetes, Dyslipidemia and Hypertension

Start date: March 12, 2018
Phase: Phase 3
Study type: Interventional

The phase III trial is designed with an aim of determining the efficacy of Investigational Product TRC150094 in concurrently reducing non-traditional risk factors for CV risk i.e., HbA1c, MAP and non-HDL cholesterol. This study will be a randomized, double blind, parallel group, placebo controlled, multi-centre, multinational study in 1250 subjects. All the study subjects will receive once daily dose of TRC150094 45 mg or placebo tablets in addition to their standard of care, for 24 weeks followed by roll over to a safety extension phase of 26 weeks.

NCT ID: NCT03251846 Recruiting - Clinical trials for Diabetes Mellitus, Type 1

Pediatrics Owning Performance Study

POPS!
Start date: July 17, 2017
Phase: N/A
Study type: Interventional

A more convenient blood glucose monitoring system integrated with a responsive mobile health app may facilitate improved diabetes control in adolescent and young adult patients with Type 1 diabetes. The primary aim of this study is to determine if the POPS diabetes management system can improve diabetes control in the adolescent and young adult population. The investigators hypothesize that use of the POPS diabetes management device and mobile application (app) will be associated with lower HbA1C after 6-months of use in adolescent and young adult T1D patients.

NCT ID: NCT03237455 Recruiting - Diabetes Mellitus Clinical Trials

Magnetic Resonance Imaging in High Risk Patients for the Development of Diffuse Idiopathic Skeletal Hyperostosis (DISH)

Start date: August 1, 2018
Phase: N/A
Study type: Interventional

Diffuse idiopathic skeletal hyperostosis (DISH) is a poorly understood, systemic condition characterized by progressive calcification and ossification of ligaments and entheses. The current classification criteria allow diagnosing the disease in its late course, when significant bony overgrowth already involves the vertebral column and the appendicular skeleton. The research of the pathogenic mechanisms in DISH, is significantly hampered by the late diagnosis resulting from this definition.Based on recent MRI studies in both axial spondyloarthritis (axSpA) and in DISH, it seems that changes similar to the classical early inflammatory changes described in axSpA, can be detected in patients with DISH. We therefore hypothesize, that patients with metabolic syndrome without radiographic evidence for spinal DISH, might exhibit early MRI changes. If this hypothesis proves to be correct, early diagnosis and research of the possible pathogenetic mechanisms at this early stage might be very rewarding in investigations of the early aberrations of the entheses homeostasis and eventually early, more targeted therapeutic interventions. The study will examine MRI changes in patients, in their 5th decade of life, with high risk for the development of DISH (ie diabetes mellitus, metabolic syndrome) compared with patients who don't have this risk.

NCT ID: NCT03230123 Recruiting - Diabetes Mellitus Clinical Trials

Effects of Green Banana BIOmass Consumption in Patients With Pre-diabetes and Diabetes MELlitus (The BIOMEL Study)

BIOMEL
Start date: May 2016
Phase: N/A
Study type: Interventional

Costa ES, Izar MC, Fonseca FAH, França C, Tria H. The benefits of green banana biomass consumption in patients with diabetes mellitus. Federal University of São Paulo, São Paulo, 2015. According to the Guidelines of the Brazilian Society of Diabetes, Diabetes Mellitus (DM) is a heterogeneous group of metabolic disorders associated with microvascular complications, hyperglycemia, resulting in a higher risk of developing cardiovascular disease. Currently, it is estimated that the world population with diabetes is 382 million people and it is expected to reach 471 million in 2035. About 80% of individuals with diabetes live in developing countries where the epidemic has greater intensity. In the Diabetes Control and Complications Trial and UK Prospective Diabetes Study demonstrated that intensive glycemic control (HbA1c ~ 7.0%) reduces chronic microvascular complications. The resistant starch (RS) is defined as starch and products of its hydrolysis are not absorbed in the small intestine. The green banana presents significant levels of RS, and it is considered a source for the intake of this substance. These foods have physiological functions in the intestinal regulation in glycemic control and delayed gastric emptying. To our knowledge, there are no long-term studies with DM to prove the benefits of resistant starch use. The objective of this study is to assess the benefits of green banana biomass consumption by patients with Pre DM and DM. Considering the possibility of improving glucose, lipid profile, increasing the secretion of glucagon-like peptide-1 (GLP-1), insulin, adiponectin, and reduction in inflammatory markers IL-6, PCR.

NCT ID: NCT03222284 Recruiting - Clinical trials for Diabetes Mellitus, Type 2

The Usability, Acceptability, and Perceived Value of the Cornerstones4Care Powered by Glooko App

Start date: July 17, 2017
Phase: N/A
Study type: Interventional

This is a two-armed mixed methods study of participants (n=30) diagnosed with type 2 diabetes who use a blood glucose meter as part of their treatment regimen. Participants will have either two or three visits at HITLAB during the 28-day study period.

NCT ID: NCT03200795 Recruiting - Diabetes Clinical Trials

Effect of Different Exercises on Musculoskeletal Pain,Glucose Level and Quality of Life Among Patients With Diabetes

Start date: March 15, 2018
Phase: N/A
Study type: Interventional

Background. Diabetes is a global epidemic disease. The prevalence of diabetes for all age groups worldwide was estimated to be 2.8% in 2000 and is predicted to affect 4.4% by 2030. The global prevalence of diabetics is currently estimated to be 285 million and projection rates are expected to rise to over 438 million by the year 2030, with Asians suffering the bulk of the total diabetes epidemic. The incidence of chronic diseases of lifestyle such as Type 2 Diabetes Mellitus (DM) is on the increase amongst the South African population. Due to the numerous factors such as lack of education, inaccessibility of healthcare facilities and/or poor socio-economic background, diabetes mellitus often goes undetected in rural areas, resulting in an increase in musculoskeletal complication and other diabetes mellitus complications. Inability to control blood sugar may induce serious complications such as renal disease, peripheral neuropathy, retinopathy, and vascular events. Due to its multi-systemic nature, diabetes will lead to the development of additional manifestations such as musculoskeletal complications, reduces respiratory capacity, depression and poor quality of life. Studies have shown that both exercises and pharmacotherapy can decreases depression and improved glycemic control and overall quality of life of persons with diabetes. Thus, in addition improve the quality of life and substantial financial savings and improved medical care of these individuals. Hypothesis 1. There will be no statistical significant difference in glycemic control, cholesterol level, respiratory parameters, pain scores, depression and quality of life among type 2 diabetes patients at the baseline and at the end of 8 weeks of rebound exercises. 2. There will be no statistical significant difference in glycemic control, cholesterol level, respiratory parameters, pain scores, depression and quality of life among type 2 diabetes patients at the baseline and at the end of 8 weeks of circuit resistance training. 3. There will be no statistical significant difference in glycemic control, cholesterol level, respiratory parameters, pain scores, depression and quality of life among type 2 diabetes patients at the baseline and at the end of 8 weeks of routine care. 4. There will be no statistical significant difference in glycemic control, cholesterol level, respiratory parameters, pain scores, depression and quality of life among type 2 diabetes patients between the rebound exercises group, circuit training and routine care at the baseline. 5. There will be no statistical significant difference in glycemic control, cholesterol level, respiratory parameters, pain scores, depression and quality of life among type 2 diabetes patients between the rebound exercises group, circuit training and routine care at the end of 8 week of the programme. Summary of the proposed research methodology. The participants will be randomised into three groups. The first group will be engaged in rebound exercise, the second group will be engaged in circuit training while the third group will continue with their normal care of medication. But before the commencement of the study, pilot study will be conducted on normal subjects. Measurement will be carried out at the baseline, four weeks and at the end of the programme, 'The following parameters will be measured. Pain level, blood glycemic level of each participant, cholesterol level, depression and quality of life.

NCT ID: NCT03194009 Recruiting - Clinical trials for Diabetes Mellitus, Type 2

PRuDENTE; Diabetes Prevention Via Exercise, Nutrition and Treatment

PRuDENTE
Start date: August 10, 2017
Phase: N/A
Study type: Interventional

The PRuDENTE study proposes to assess if metformin therapy a viable, efficient and cost-effective intervention to decrease the incidence of type 2 diabetes (DMT2) in adult subjects with obesity and pre-diabetes in Mexico City. Half of the individuals recruited will receive as intervention, metformin and lifestyle modification therapy and the other half will receive only lifestyle modification therapy.