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Diabetes Mellitus, Type 2 clinical trials

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NCT ID: NCT03867942 Not yet recruiting - Clinical trials for Diabetes Mellitus, Type 2

BE Study of Bilayer Combination of Gemigliptin/Rosuvastatin 50/20mg in Comparison to Monolayer Combination.

Start date: March 21, 2019
Phase: Phase 1
Study type: Interventional

To evaluate and compare PK/PD, safety and tolerability of monolayer combination of Gemigliptin/Rosuvastatin 50/20mg and bilayer combination of Gemigliprin/Rosuvastatin 50/20mg in healthy adults.

NCT ID: NCT03851549 Not yet recruiting - Diabetes Mellitus Clinical Trials

A User Performance and System Use Evaluation of a New Blood Glucose Monitoring System ( BGMS)

Start date: March 12, 2019
Phase: N/A
Study type: Interventional

This study is the US Regulatory Clinical Evaluation - User Performance and System Use Evaluation of a new Blood Glucose Monitoring System (BGMS).

NCT ID: NCT03850314 Not yet recruiting - Obesity Clinical Trials

The Effects of Glycine on Atherosclerosis and Metabolic Syndrome-related Parameters.

Start date: March 2019
Phase: Phase 2/Phase 3
Study type: Interventional

The current study will test the central hypothesis that Glycine supplementation in humans improves Lipid profile and therefore reduces the risk of Atherosclerosis. Secondary outcomes including Insulin sensitivity and parameters related to Metabolic Syndrome (MetS) will also be measured. Furthermore, a mechanistic study in an ex-vivo model will test the hypothesis that Glycine via its key biosynthetic pathway involving Serine Hydroxymethyltransferase 2 (SHMT2), is athero-protective by inhibiting Sterol regulatory element-binding protein 2 (SREBP2)-mediated cholesterol biosynthesis in murine macrophage-like cell line.

NCT ID: NCT03821220 Not yet recruiting - Diabetes Mellitus Clinical Trials

Improving Physical Activity Levels in the Arabic- Speaking Residents of East Jerusalem With Prediabetes

Start date: February 15, 2019
Phase: N/A
Study type: Interventional

This three-arm clinical trial aims to improve levels of physical activity among Arabic- speaking residents of East Jerusalem with prediabetes. Levels of daily physical activity (assessed through activity trackers), dietary habits and self-assessed health will be compared between patients that receive only the activity tracker and written information (group A), receive the activity tracker, written information and a personalized physical activity prescription (group B), and those that receive in addition also intensive follow-up with motivational interview by physician assistants and a dietitian (group C)

NCT ID: NCT03776448 Not yet recruiting - Diabetes Mellitus Clinical Trials

The Effect of 2 Grams Daily Supplementation of Sativa Nigra Oil on Blood Glucose Levels of Adults.

Start date: January 2019
Phase: N/A
Study type: Interventional

Diabetes mellitus is a growing global concern with significant health and financial burdens. The Kingdom of Saudi Arabia is one of the world's top 10 countries with the highest diabetes prevalence. Strict blood glucose control is an important measure in the treatment of diabetes and prevention of its complications. The scientific community has recently shown a profound interest in the area of complementary and alternative medicine where a ton of research is being conducted. The primary focus of this field of research is subjecting many of the medicinal plants used in herbalism to the scientific methodology of testing. In order for these plants to be implemented in treatment protocols, their effect must be clearly proven and documented scientifically. This study aims to investigate the effect of daily consumption of black seed oil on the blood sugar levels of healthy adults.

NCT ID: NCT03734445 Not yet recruiting - Clinical trials for Diabetes Mellitus, Type 2

Effect of Vitamin C, D and Zinc Supplementation on the Immune and Inflammatory Process in Type 2 Diabetic Subjects

Start date: January 9, 2020
Phase: N/A
Study type: Interventional

Type 2 Diabetes Mellitus According to the World Health Organization (WHO), there are more than 346 million individuals with diabetes, of which 90% are type 2. Global estimations for the year 2030 predict an epidemic increase that will reach 366 million. According to the National Nutrition and Health Survey of 2006 (ENSANUT2005), there are 6.4 million type 2 diabetic subjects in Mexico. According to the calculation of the sample size, the investigators will include 120 adults with type 2 diabetes mellitus selected from the outpatient preventive medicine offices of health centres in the State of Mexico who will divided in two groups: supplement and placebo (60 per group). After having been invited to participate and obtaining the informed consent, study subjects will be evaluated for dietary information, as well as biochemical biomarkers of metabolic control, anthropometric, immune and inflammatory markers, gut microbiota and oxidative stress, before beginning the trial, and after 12 and 24 weeks of supplementation. They will have a monthly follow-up visit for evaluation of adherence and adverse effects, as well as delivery of the supplement.

NCT ID: NCT03700645 Not yet recruiting - Diabetes Mellitus Clinical Trials

Allopurinol in Diabetes Mellitus and Multivessel Coronary Artery Disease

Start date: December 1, 2018
Phase: Phase 4
Study type: Interventional

Atherosclerosis is a progressive disease of the arterial wall, arising from the combination of endothelial dysfunction and inflammation. This link is exacerbated in diabetic patients. Uric acid is known to generate oxidative stress and it's elevated levels has been shown to be associated with cardiac hypertrophy, inflammation, myocardial fibrosis and diastolic dysfunction. Allopurinol inhibits xanthine oxidase, an enzyme that regulates uric acid production. In observational studies it has been shown to reduce ischemia, inflammation and improve coronary flow. The aim of this study is to see whether treatment with Allopurinol in patients diagnosed with multivessel disease and undergoing treatment with either percutaneous coronary intervention (PCI) or coronary artery bypass surgery (CABG) , will reduce markers of inflammation and improve quality of life and major adverse cardiovascular effects (MACE).

NCT ID: NCT03648554 Not yet recruiting - Clinical trials for Diabetes Mellitus, Type 2

Researching an Effect of GLP-1 Agonist on Liver STeatosis (REALIST)

REALIST
Start date: September 1, 2019
Phase: Phase 4
Study type: Interventional

GLP-1 analogues represent new treatments in diabetes that cause weight loss. Their effect on NASH in humans is unknown. A decrease in Alanine Aminotransferase (ALT) has been reported in pooled Exenatide/Placebo and Liraglutide/Placebo studies. More recently, LEAN study has shown that Liraglutide will result in improvements in liver histology in patients with NASH. It should be of high interest to investigate the effect of another GLP-1 Agonist as effective as Liraglutide, i.e. Dulaglutide in NASH. Dulaglutide is one of the five GLP-1 receptor agonists approved for type 2 diabetes mellitus (T2DM). It is an effective treatment because it is dosed once-weekly, provides HbA1c reduction similar to Liraglutide, weight reduction similar to Exenatide, and has an adverse effect profile similar to other GLP-1 receptor agonists. Reduction in body weight was observed in patients treated with Dulaglutide, irrespective of nausea and/or vomiting.The search for a direct effect of Dulaglutide on liver fat overload in patients with type2 diabetes is required before considering the effectiveness of this treatment in NASH in diabetic populations. No current GLP-1 study has been designed with a control group with the same weight loss than as in the treatment group. Primary objective: The investigators aim to study the effect of Dulaglutide 1.5 mg (TRULICITY®) add-on to dietary reinforcement after 52 weeks of treatment, on the improvement of liver histology compared to dietary reinforcement alone in patients with type 2 diabetes and carriers of non-alcoholic steatohepatitis. Secondary objectives: - After 52 weeks of treatment, to assess the effect of dulaglutide (TRULICITY®) add-on to dietary reinforcement on Fibrosis score, Transaminase levels, body composition as measured by dual energy X-ray absorptiometry, lipid profile, glycemic control and weight. The effect of the treatment will also be assessed on quality of life. - At 24 weeks after completion of the treatment, to assess the sustainability of dulaglutide (TRULICITY®) treatment add-on to dietary reinforcement on ALT and AST rates as well as on weight.

NCT ID: NCT03629704 Not yet recruiting - Diabetes Clinical Trials

Relationship Between Blood Glucose Variability and Prognosis in Critically Ill Patients

Start date: August 3, 2018
Phase:
Study type: Observational

This study is to evaluate the glycemic variation using Continuous Glucose Monitoring System in patients in the intensive care unit, find out the occult hypoglycemia, and investigate the relationship between glycemic variation, especially the incidence of hypoglycemia and prognosis of patients. Meanwhile, the inflammatory factors were measured and the relationship between inflammatory factors and glycemic variation.

NCT ID: NCT03622957 Not yet recruiting - Clinical trials for Diabetes Mellitus, Type 2

Association Between Phthalates Exposure and Renal Function Impairment in TYpe 2 Diabetes

PURITY-2
Start date: August 10, 2018
Phase:
Study type: Observational

The global incidence of diabetic nephropathy (DN) is increasing, with no appreciable reduction in the percent of patients progressing toward end stage renal disease (ESRD) and dialysis (Tuttle et al, 2014, Winocour et al, 2018). Therefore, identification of modifiable risk factors and early biomarkers of progressive decline in kidney function is an urgent clinical need. Phthalates are environmental and dietary contaminants with a various array of use that are identified in many consumer and industrial products; among them, di-(2-ethylhexyl) phthalate (DEHP) and its metabolites (mono 2-ethylhexyl phthalate (MEHP), 5OH-MEHP (MEHHP) and 5oxo-MEHP (MEOHP)) are widely used (Kato et al 2004, Braun et al, 2013). They partially distribute to the human tissues and their urinary and serum levels are directly related; therefore, urinary concentration of phthalates is commonly used as proxy of their exposure in humans (Kato et al 2004). While the association between phthalates exposure and development of T2D is currently being explored (Dong et al 2017, Dales et al, 2018), little is known about their role in DN. Recent observations show that DEHP and its metabolites are associated with a higher prevalence of low-grade albuminuria and in children exposed to higher phthalates concentrations (Trasande et al, 2014, Wu et al, 2018), however such association has yet to be verified in adults. The environmental ubiquity of the phthalates enhances the importance of investigating the potential relation between their exposure and different degrees of renal function. (Kato et al 2004, Kataria et al, 2015). Given this premise, the investigators will explore this potential association in a population of subjects with T2D consecutively referring to the outpatient diabetes clinic in Santa Chiara Hospital, Pisa, enrolled on a volunteer basis. During their routine visit at Santa Chiara Hospital outpatient diabetes clinic participants will provide the results of blood tests prescribed as per standard clinical practice along with a first morning, overnight fasting, urine sample collected in a phthalates-free container. The investigators will record the participants' clinical history, physical examination and anthropometric measurements, will measure their renal function, evaluated by eGFR (calculated with the CDK-EPI formula), albumin excretion, fasting glucose, HbA1c%, and the exposure to phthalates, assessed by total concentrations of MEHP, MEOHP, MEHHP and adjusted for urinary creatinine. In this way, the investigators aim to point out the relationship of urinary phthalates with higher degrees of albuminuria and/or lower eGFR after adjustment for all potential confounders, including therapies.