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NCT ID: NCT03314246 Recruiting - Clinical trials for Diabetes Mellitus, Type 2

Development and Implementation of Ramadan Fasting Algorithm for Singaporeans With Type 2 Diabetes

FAST
Start date: April 3, 2017
Phase: N/A
Study type: Interventional

Background: Ramadan fasting is a religious observance carried out by Muslims all over the world. During Ramadan, Muslims abstain from eating, drinking, and smoking during daylight hours. Although Muslims who are ill, including patients with diabetes, are exempted from fasting, many devoted Muslim patients still insist on fasting despite being advised not to by their healthcare providers. Concerns have been raised over how the practice of fasting may affect the metabolic control of Muslim patients with diabetes. Furthermore, it has also been postulated that the act of fasting may increase the risk of hypoglycemia or glucose toxicity. Although practice algorithms and suggestions on the use of glycemic therapies during fasting have been discussed internationally. they are not generalizable as the observances of Ramadan, duration of fasting and the food ingested differ from one country to another. Aims: This study aims to develop and implement a clinical practice dose-adjustment algorithm dedicated to the care of Singaporean patients with diabetes who fast during Ramadan. Hypothesis: The use of clinical practice dose-adjustment algorithm can improve both clinical and humanistic outcomes of patients with type 2 diabetes who wish to fast during Ramadan. Methods: This is a prospective, randomized, interventional study involving patients with type 2 diabetes who wish to fast for at least 10 days during Ramadan. Eligible patient attending a primary care institution or an outpatient specialist clinic of a tertiary institution will be approached to participate in the study. Consented patients will be randomized to either intervention arm or control arm. Patients in the control arm will receive usual care while patients in the intervention arm will be given additional education session on Ramadan fasting related diabetic management advice and an algorithm that was developed by the study team members based on international guidelines, to guide them on self-management during Ramadan. The primary outcomes will be change in HbA1c. Secondary outcomes include change in fasting blood glucose, post prandial blood glucose, medication adherence and humanistic outcomes. The safety outcomes include self reported incidence of major and minor hypoglycemia as well as hyperglycemia during Ramadan month. All outcomes will be measured at baseline, during Ramadan and at 3 month post Ramadan. Significance: The validation of the algorithm through this study will ensure effective and safe fasting of patients with type 2 diabetes during Ramadan.

NCT ID: NCT03309254 Active, not recruiting - Pre Diabetes Clinical Trials

Role of Glycaemic Index and High Protein Meal in Response of Blood Biomarkers for Pre-diabetes

Start date: January 18, 2016
Phase: N/A
Study type: Interventional

This study aims to demonstrate the effectiveness of increased protein ingestion, particularly when coupled with a low glycaemic index (GI) to reduce biomarkers related to high risk of diabetes.

NCT ID: NCT03299075 Recruiting - No Phone Clinical Trials

The Effect of Social Media Use on Eating Behaviours

Start date: August 28, 2017
Phase: N/A
Study type: Interventional

This project aims to explore how social media use, in particular food photography, influences eating behaviours. It will be approached through three methods - a correlational experience sampling method, an experimental experience sampling method, and an experimental laboratory method.

NCT ID: NCT03297008 Recruiting - Healthy Clinical Trials

Biomarkers in Saliva and Stool

Start date: March 11, 2015
Phase: N/A
Study type: Observational

Many soluble factors found in blood can be detected in saliva and stool. Often levels of these factors are found to correlate between body fluids, though the exact relationship between systemic (blood) and local (saliva and stool) immunity is not well established yet. Saliva- and stool-associated factors are produced in the oral cavity and in the gut, which represent mucosal sites that potentially come in direct contact with pathogens. Thus, the levels of mucosal-associated soluble factors can better represent the local immune response at these sites. It is becoming clear now that saliva and stool can be used to analyze inflammatory responses as well. In a recent study, 20 possible salivary biomarkers related to obesity were surveyed and the authors found four biomarkers that exhibit significant change with increasing body weight in a pediatric population. Salivary C-reactive protein (CRP), salivary insulin, leptin and adiponectin were found to be different in obese children compared to healthy normal weight children. This data suggests that saliva could be a useful blood surrogate for the study of metabolic complications of obesity in children, where repeated blood sampling can be both traumatic and difficult. The results of this study also provide insight into the early development of metabolic disease in children. (Goodson, Kantarci et al. 2014). In another study, cytokines-chemokines-growth factors (CCGFs) were measured using multiplex bead assays and compared between plasma, saliva and urine collected from 20 male and female healthy volunteers. By analyzing more than one sample types from the same subject would increase the possibility of identifying biomarker(s) for any inflammatory disease. In this study, gender-specific CCGFs were also observed and concentrations of some CCGFs varied between genders. This information is also valuable for biomarker discovery that by combining male and female subjects in a clinical trial would eliminate false discovery of biomarkers (Khan 2012). The mucosal immune system can be also understood by analyzing stool samples. In a recent study, it is shown that a particular bacterial predominance, such as Bifidobacterium sp., may enhance thymic development and immune responses to both oral and parenteral vaccines early in infancy, whereas a deviation from this pattern, resulting in greater bacterial diversity, may cause systemic inflammation (neutrophilia) and lower vaccine responses. Thus, vaccine responsiveness may be improved by promoting intestinal Bifidobacteria sp. and minimizing dysbiosis early in infancy (Huda, Lewis et al. 2014). Of note, the hallmark of adequate mucosal immune responses is the production of secretory immunoglobulin A (SIgA), which can prevent infection and remove antigen crossing the mucosal barrier.SIgAis also imperative to establish mutualism between host and the intestinal microbiota (Maynard, Elson et al. 2012). Hence measurement of SIgA can help to assess the mucosal immunity. Despite saliva and stool samples are increasingly studied in order to assess mucosal immune response and/or clinical outcomes, there is still a lack of established methodology to be routinely used in diagnostic laboratories and clinical trials. Therefore our aim is to collect saliva and stool samples using the salimetrics swab and self-stool collection kit from a cohort of 60 volunteers, process and store samples in a standardized manner. Following this, we intend to perform immunological assays such as enzyme-linked immunosorbent assay, multiplex bead assay and Immunocap to correlate the salivary and fecal levels of biomarkers in healthy donors. As this method is non-invasive, we believe that more people will be willing to donate samples. It is also easy to self-collect and it is cost efficient.

NCT ID: NCT03286634 Not yet recruiting - Clinical trials for Acute Lymphoblastic Leukemia

ASIA Down Syndrome Acute Lymphoblastic Leukemia 2016

Start date: October 2017
Phase: Phase 2
Study type: Interventional

To evaluate the outcome of a prednisolone and low dose methotrexate based protocol in Down syndrome children with ALL (DS-ALL) in an Asia-wide study. The treatment protocol was modified based upon backbone of Taiwan Pediatric Oncology Group (TPOG)-ALL protocol in which risk classification will be guided by level of flow minimal residual disease (MRD) instead.

NCT ID: NCT03282617 Recruiting - Clinical trials for Nasopharyngeal Cancer

Dendritic Cell Therapy With CD137L-DC-EBV-VAX in Locally Advanced Stage IV or Locally Recurrent/Metastatic Nasopharyngeal Carcinoma

Start date: August 14, 2017
Phase: Phase 1
Study type: Interventional

This study is carried out to find out the safety and recommended dose of CD137L-DC-EBV-VAX in nasopharyngeal cancer. CD137L-DC-EBV-VAX is a product made from one of our own immune system cells (dendritic cell, DC). Dendritic cells are immune cells that help to stimulate our body's T lymphocytes to fight cancer by presenting specific proteins from the cancer cells. The investigators have developed in the laboratory a highly effective dendritic cell which is primed to activate T cells with the Epstein-Barr virus (EBV) proteins. It is hoped that this will stir an immune response to recognize NPC cells and kill them as part of body's immune surveillance system.

NCT ID: NCT03279107 Recruiting - Obesity Clinical Trials

Effects of Different Types of Carbohydrates in Snacks and Beverages on Glycemia, Insulinemia and Appetite.

Start date: August 25, 2017
Phase: N/A
Study type: Interventional

The aim of the study is to describe the glycemic, insulinemic and appetitive responses to liquid and solid foods where either soluble fiber or maltodextrin are used as the carbohydrate substrate.

NCT ID: NCT03277326 Recruiting - Interscalene Block Clinical Trials

Interscalene vs Anterior and Posterior Suprascapular Nerve Block for Shoulder Arthroscopic Surgeries

Start date: August 30, 2017
Phase: N/A
Study type: Interventional

To compare ISB vs anterior and posterior approaches of suprascapular block in terms of lung function and analgesia

NCT ID: NCT03275896 Recruiting - Clinical trials for Fuchs' Endothelial Dystrophy

Evaluation of the Efficacy of Descemet Membrane Transplantation for the Treatment of Fuchs' Endothelial Dystrophy

Start date: September 2016
Phase: Early Phase 1
Study type: Interventional

Fuchs Endothelial Dystrophy (FED) is a degenerative disease affecting the corneal endothelium. The current gold-standard for treatment of severe FED is endothelial keratoplasty, wherein a cadaveric Descemet's membrane / endothelium graft is transplanted. In this study, the investigators hypothesized that the transplantation of an acellular Descemet's membrane (i.e. Descemet Membrane Transplantation, 'DMT') may be equally efficacious in promoting recovery of endothelial function in this group of patients.

NCT ID: NCT03275558 Suspended - Gliosarcoma Clinical Trials

Clinical Trial of the Use of the Nasal Spray of Patients With Recurrence of Glioblastoma

Start date: October 2017
Phase: Phase 1
Study type: Interventional

This is a study to determine the efficacy, safety and clinical benefit (how well the drugs works), of the pharmaceutical compositions in Nasal Spray NST-4G for the treatment of brain tumors( Recurrent Glioblastoma, Gliosarcoma,Anaplastic Gliomas, Previously Treated). All drugs target the inhibition of the growth factors and neo-angiogenesis as one the main reasons for the growth of the tumor. The purpose of the Nasal Spray NST-4G study is to determine the safety and tolerability in order to establish the best dose level to be used in future studies.