Active clinical trials for "Diabetes Complications"

Charcot neuropathic osteoarthropathy (CNO) is a progressively destructive process resulting from significant peripheral neuropathy of almost any aetiology. Diabetes mellitus has emerged as the commonest cause of CNO. The Charcot foot in diabetes poses many clinical challenges in its diagnosis and management. The lacuna primarily lies in delineation of its etio-pathogenesis and consequently in targeted treatment modalities. Although traditional approaches focus on neurotraumatic and neurovascular theories, these fail to explain all the features of CNO, hence, other hypotheses have been put forward.The current belief is that once the disease is triggered in a susceptible individual, it is mediated through a process of uncontrolled inflammation which, in turn, leads to osteolysis, fractures and joint destruction. Of these processes, the involvement of the receptor activator of nuclear factor- кB (RANK) ligand /RANK/osteoprotegerin (OPG) system in the process of acute CNO is particularly appealing and suggests new pharmacological approaches. Standard modalities of treatment include offloading and casting. Although various trials have analysed the impact of medical agents including bisphosphonates, teriparatide and bone stimulation techniques, the results have been either inconclusive or not translated into clinical practice. Hence, there is no efficacious treatment of active CNO apart from the traditional offloading. In view of recent advances in understanding of the disease process, the target of intervention should, logically, be interruption of the inflammatory cascade and subsequent osteoclast resorption. Zoledronic acid is the most potent bisphosphonate that has been studied in clinical trials to date and has the distinctive profile of strong inhibitory activity on the enzyme farnesyl pyrophosphate synthase, essential for osteoclast function. Methylprednisolone conceivably has a potential benefit by offsetting the RANKL/OPG system involved. There have been conflicting reports with bisphophosphonates in active CNO and Zoledronic acid has been infrequently used despite being the most potent. Glucocorticoids including methylprednisolone have also not been systematically tried in this condition. We hypothesise that targeting the inflammatory cascade with Methylprednisolone and osteoclast mediated damage by Zoledronic acid will address the basic etiopathogenesis of active CNO and may result in earlier resolution of the disease activity. The above mentioned hypothesis is hence, planned to be tested in a randomised, double-blind, placebo-controlled study.

This is a prospective, open, randomized study involving 100 patients with microvascular complications of type 2 diabetes mellitus and obesity, who will undergo gastric bypass (Roux-en-Y gastric bypass ARM A) or receive best medical treatment (ARM B, control arm). The aim of this study is to evaluate the effects of Roux-en-Y gastric bypass in the control of diabetic nephropathy in diabetic patients with BMI between 30 and 35 kg/m2. The medical community is confronted with many different studies using various methodologies to investigate the best pharmacological treatment for type 2 diabetes mellitus. The treatment algorithm offers several different options according to the stage of the disease (which is different in each study). In addition, new drugs are being developed over the years, but are not always a guarantee of effective type 2 diabetes mellitus control [MENDES, 2010]. Furthermore, these drugs do not prevent the development of this disease, consequently increasing the risks of microvascular and macrovascular complications. Conversely, there is considerable evidence that surgery can be an adequate tool to promote type 2 diabetes mellitus remission in patients who are unresponsive to clinical treatment. Gastric bypass surgery is one of the most popular bariatric surgeries in the world, but its effects on microvascular and macrovascular complications of type 2 diabetes mellitus have not been established. Specialists suggest that the rapid and uncontrollable decrease in blood glucose adds to the concern that the surgery may paradoxically cause exacerbation of microvascular complications [LEOW, 2005], whereas gradual improvement in blood glucose before gastric bypass surgery may prevent this paradoxical worsening, leading to an interruption of this process, or even retinopathy, nephropathy, and neuropathy remission. However, there are no studies comparing the results of these two types of treatment (clinical vs. surgical) in a similar population and assessing the development of microvascular complications of type 2 diabetes mellitus. Therefore, in order to clarify such doubts, it is necessary and extremely desirable to conduct a randomized controlled trial comparing gastric bypass with the best and most modern clinical treatment. Its findings could have a direct impact on hundreds of millions of diabetics by allowing the inclusion of surgical treatment as a safe and feasible therapeutic option for a significant portion of these patients.

The purpose of this study is to evaluate the pharmacodynamic (PD) and pharmacokinetic (PK) profile and the safety and tolerability of RM-131 in patients with diabetes mellitus and delayed gastric emptying.

This study will test whether lowering the delivery of excess fats to the heart in persons with type-2 diabetes mellitus improves heart muscle function. The investigators will also test whether specific lipid molecular species in plasma can serve as biomarkers for diabetic heart disease.

The purpose of the study is to determine if inspiratory muscle training improves inspiratory muscle strength of type 2 diabetes mellitus patients with inspiratory muscle weakness.

This study will enrol patients with diabetes who have already elected to undergo pars plana vitrectomy (eye surgery) to remove persistent vitreous haemorrhage (a complication of severe diabetic eye disease in which blood fills the inner cavity of the eye, obscuring the vision and preventing treatment to stop the bleeding). Those in the treatment arm will have an intravitreal injection of ranibizumab (Lucentis) at the same dose used for the treatment of neovascular (wet) age-related macular degeneration (a disease that has some features in common with diabetic eye disease). It is hypothesised that this will promote clearance of the vitreous haemorrhage and that this, in turn, may mean that some patients do not need to proceed to vitrectomy.

Cocarnit is a metabolic complex containing disodium adenosine triphosphate trihydrate, cocarboxylase, cyanocobalamin and nicotinamide. Aim: To test the effects of Cocarnit on pro- and anti-inflammatory activation of blood-derived monocytes-macrophages from Type 2 diabetic patients. Study design: Measurements of stimulated and basal secretion of TNF-alpha and CCl-18 before and at 2 and 4 hours after single intramuscular administration of Cocarnit at first day and after 30 days of follow-up in 40 Type 2 diabetic patients with/without polyneuropathy. Methods: The profile of monocyte polarization was determined in vitro in primary cell culture of blood-derived monocytes-macrophages after pro-inflammatory stimulation by bacterial lipopolysaccharide and after anti-inflammatory stimulation by interleukin-4, according to tumor necrosis factor (TNF) and CCL18 chemokine secretion, respectively.

This prospective double-blind placebo-controlled trial aims to investigate the safety and efficacy of oral dispersible tablet of vitamin B12 for 1 year, in 90 patients with diabetes mellitus type 2 and neuropathy.

The Study was divided into three Phases: Screening Phase (1-2 weeks); Treatment Phase (~ 1 month); and Follow-up Phase (two weeks). During the Screening Phase, blood samples were taken for analysis of blood count, liver and kidney functions from potential appropriate diabetic patients with chronic wounds in their foot. Stable chronic diabetic patients, whose wounds were not infected and the wound size increased or did not decreased by more than 25% per week or 35% by SOC treatment during the Screening Phase, and who will meet all other study inclusion criteria, were enrolled and start the 4 weeks Treatment Phase. The wounds were then treated by applying the Copper Oxide containing Dressings (COD) that were changed twice a week. In the two weeks post-treatment period, the patient received standard of care (SOC) dressing. In that time period, the patient were seen once after two weeks. The Primary outcome was the evaluation of the safety of the COD and the secondary outcomes were the evaluation of the wound size change of the foot wounds when using COD. Measures that were assessed included Percent change in wound size during the Treatment Phase, Rate of increase in extent and quality (color) of granulation tissue, Infectious episodes during the Treatment Phase.

Introduction Diabetes is a global emergency with detrimental clinical and financial consequences. Poorly managed diabetes leads to a myriad of serious complications, especially cardiovascular and infectious complications, with consequent increased cost and mortality rate. For Muslims in particular, the annual fasting month of Ramadan is one such period when diabetes control is essential. Adequate adjustments in diabetes management need to be made in line with the allowed meal times to avoid the risk of diabetes complications during Ramadan. Objective Investigators aim to investigate the effectiveness of focused diabetes education and medication adjustment with telemonitoring to reduce diabetes complications during Ramadan fasting as well as to assess the cost-effectiveness of this intervention for Muslims with diabetes in Singapore. Methodology In a parallel group randomized controlled trial, investigators aim to recruit 100 adults with diabetes who are able to fast at least 15 days in Ramadan. You will be randomized to the intervention group comprising of focused diabetes education, medication adjustment and telemonitoring, and control group receiving standard care. You will be followed up during Ramadan. The primary outcome is the incidence of hypoglycemia in Ramadan. The secondary outcomes are (i) incidence of other diabetes complications in Ramadan episodes including hyperglycemia, episodes of acute infections, attendances in clinic and emergency department and that of hospital admission, and (ii) cost-effectiveness of the intervention. Clinical Significance The study enables investigators to evaluate focused pre-Ramadan diabetes education and medication adjustment with tele-monitoring as a means to reduce the markedly increased risk of diabetes complications for a large population during the fasting month, with potential for increased cost-effectiveness through reducing unscheduled attendances at clinic and hospital.