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Diabetes Mellitus, Type 2 clinical trials

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NCT ID: NCT03739268 Recruiting - Clinical trials for Type 2 Diabetes Mellitus

GLP-1-mediated Gluco-metabolic Effects of Bile Acid Sequestration

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

The objective of this study is to investigate the potential GLP-1-mediated contribution to the well-established glucose-lowering effect of sevelamer-induced bile acid sequestration . Exendin9-39 has been demonstrated to act as a potent and specific GLP-1 receptor antagonist with no partial agonistic potential and is considered a useful tool in the assessment of GLP-1 physiology. The aim is to evaluate any contribution of sevelamer-induced GLP-1 secretion to the reduced plasma glucose concentrations observed after treatment with sevelamer. A randomised placebo-controlled cross-over study involving two 17-day treatment periods with sevelamer and placebo, respectively, in metformin-treated patients with type 2 diabetes, will be conducted. The impact of bile acid sequestration on GLP-1 secretion and effect will be examined during two randomised experimental days after 15 and 17 days of treatment with sevelamer (1,600 mg three times a day) and placebo, respectively. During each of these two experimental days, a meal test with concomitant exendin9-39 infusion or placebo will be performed (for evaluation of any GLP-1-mediated effects). Postprandial plasma glucose excursion is the primary endpoint, and secondary endpoints include postprandial plasma/serum excursions of insulin, C-peptide, GLP-1, glucagon, glucose-dependent insulinotropic polypeptide (GIP), glucagon-like peptide-2 (GLP-2), peptide YY (PYY), oxyntomodulin, ghrelin, fibroblast growth factor (FGF)-19, FGF-21, C4 (an intermediate in the de novo synthesis of bile acids), cholecystokinin (CCK), bile acids and plasma lipids. Furthermore, gastric emptying, gallbladder emptying, liver fat content, appetite and ad libitum food intake will be examined.

NCT ID: NCT03739125 Recruiting - Type2 Diabetes Clinical Trials

Efficacy and Safety of CKD-501 Added to D150 Plus D745 10mg Therapy in Patients With Type 2 Diabetes

Start date: November 9, 2017
Phase: Phase 3
Study type: Interventional

The purpose of this study is to prove that the group treated with CKD-501 in combination added that the reduction of glycated hemoglobin superior to placebo treated group added in combination.

NCT ID: NCT03738449 Not yet recruiting - Clinical trials for Type 2 Diabetes Mellitus

The Clinical Trial to Investigate the Pharmacokinetics and Safety/Tolerability of CKD-387 Under Fed Condition

Start date: December 7, 2018
Phase: Phase 1
Study type: Interventional

The purpose of this clinical trial is to evaluate the pharmacokinetics and safety/tolerability after oral administration of CKD-387 and D484 under fed condition in healthy adults.

NCT ID: NCT03737942 Not yet recruiting - Clinical trials for Diabetes Mellitus, Type 2

Effect of Type II Diabetes Mellitus With Neuropathy on the Clinical Use of Rocuronium

Start date: December 2018
Phase:
Study type: Observational

International Diabetes Federation estimates that there are now 415 million adults aged 20-79 with diabetes mellitus worldwide. By 2040 this will rise to 640 million. Although diabetes mellitus is highly prevalent in our environment and one of the most important challenges of modern medicine, only a handful of studies have examined the neuromuscular function in diabetic patients. The shortage of publications in this area is still more surprising if we consider that the neuromuscular blockers are one of the pillars in the administration of general anesthesia. Neuromuscular blockers during surgery are used in tracheal intubation and to improve surgical conditions.

NCT ID: NCT03736785 Not yet recruiting - Clinical trials for Type 2 Diabetes Mellitus

A Study of LY3209590 in Participants With Type 2 Diabetes Mellitus

Start date: November 15, 2018
Phase: Phase 2
Study type: Interventional

The reason for this study is to see if the study drug LY3209590 is safe and effective in participants with type 2 diabetes that have already been treated with basal insulin.

NCT ID: NCT03736668 Recruiting - Type2 Diabetes Clinical Trials

Study of Left Ventricular Function in a Cohort of Patients With Type 2 Diabetes Without Cardiovascular Disease

DIACAR
Start date: May 22, 2018
Phase: N/A
Study type: Interventional

Type 2 diabetes is associated with high cardiovascular risk. Recent meta-analyzes suggest that the risk of hospitalization for heart failure in the diabetic is increased by 20% for each hemoglobin A1c point and that the risk of death from all causes or cardiovascular cause and the risk of hospitalization is significantly increased by 30 to 40% in patients with acute or chronic heart failure with diabetes. Systematic analysis of cardiac function is not currently proposed in international recommendations even though some antidiabetic drugs have been associated with an increased risk of heart failure in large randomized controlled trials or an increase in adverse events in proof-of-concept studies of heart failure with or without diabetes. Similarly, observational studies suggest that hypoglycemic sulfonamides may increase the risk of developing heart failure. In contrast, two inhibitors of co-transporter Sodium Glucose type 2 (empagliflozin and canagliflozin) have recently demonstrated a significant reduction in hospitalizations for heart failure in two large randomized controlled trials. The detection of subclinical left ventricular dysfunction is therefore essential to better assess the risk of cardiac decompensation and to identify the existence of possible contraindications to the use of certain classes of drugs used in diabetes. Recent studies suggest that the left ventricular ejection fraction measured on three-dimensional acquisitions is a prognostic value index greater than the ejection fraction measured by Simpson biplane method in two-dimensional ultrasound. Similarly, it seems that the analysis of global longitudinal deformation is a prognostic factor superior to the analysis of the ejection fraction (two-dimensional or three-dimensional). The investigators will analyze these different parameters on their population to try to confirm these data.

NCT ID: NCT03736486 Enrolling by invitation - Clinical trials for Cardiovascular Diseases

Mil Familias-Santa Barbara's Operational Pilot to Understand Diabetes in the Latino Community

MilFamilias
Start date: August 24, 2017
Phase:
Study type: Observational

The Mil Familias Program is a 10-year initiative to reduce the burden of cardio-metabolic disease among Latino families in the Central Coast of California. The Mil Familias Program involves enrolling 1000 Latino families with at least one member in the family having type 2 diabetes, measuring the 5 determinants of human health: genetics, biology, behavior, psychology and environment, training Latino community health workers ("Especialistas") , creating a Living Information (bio)Bank and planning culturally-relevant interventions.

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 8, 2019
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: NCT03733743 Recruiting - Clinical trials for Diabetes Mellitus, Type 2

Day-night Rhythm in Muscle Metabolism of Prediabetics

Start date: July 9, 2018
Phase: N/A
Study type: Interventional

This study evaluates the existence of a day-night rhythm in skeletal muscle energy metabolism in prediabetic subjects. Subjects will stay at the research facility for 44 hours with a standardized living protocol during which several measurements of skeletal muscle and whole body energy metabolism will be performed.

NCT ID: NCT03732690 Not yet recruiting - Type 2 Diabetes Clinical Trials

The Interaction Between Protein Intake, Gut Microbiota and Type 2 Diabetes in Subjects With Different Ethnic Backgrounds

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

Context and justification: There is growing evidence that the gut microbiota is a key element in the pathophysiology of cardio-metabolic diseases (CMD) such as Type 2 Diabetes (T2D). One hypothesis is that gut-derived metabolites (from diet) have an important role in the host metabolism. Preliminary results show that imidazole propionate (ImP), a degradation product of the essential amino acid histidine, is produced by the gut microbiota of T2D patients, but not healthy subjects. The gut microbiota itself is strongly influenced by diet and ethnicity. However, most dietary intervention studies have focused on the role of fiber intake and the effect of dietary protein on the gut microbiota composition and metabolite production is not well known. Our hypothesis is that, depending on the baseline gut microbiome composition, a diminution in protein intake could decrease the microbial production of metabolites such as ImP and improve the metabolism of the host. We also hypothesize that the effects of such an intervention could depend the ethnic background. Objective: To study the effects of a high protein (HP) vs a low protein (LP) diet on gut microbiota composition and production of pro-diabetic metabolites in type 2 diabetes (T2D) patients from Caucasian and Caribbean ethnicity depending on baseline metagenomics richness. Study design: Randomized controlled three months dietary intervention study Study Population: T2D patients from Caucasian (N=80) and Caribbean (N=40) background who are on a stable dose of metformin and do not use insulin or proton-pump inhibitors. Intervention: Subjects will be randomized to either a high protein (HP) or low protein (LP) diet for three months. Individuals of Caucasian ethnicity, will also be stratified according to either a high or low gut microbiota gene richness. All subjects will receive pre-cooked meals 6 days per week and daily food packages. Subjects are required to keep food diaries three days a week and will also have weekly contact with an Pitié-Salpêtrière dietician. Outcome measures: Primary endpoint is the change in glycemic excursion (area under the curve) after a mixed meal test between baseline and 12 weeks after the beginning of the intervention. Furthermore, we will study oral and fecal microbiota composition changes as well as serum levels of intestinal metabolites, such as ImP, body weight and body composition at baseline and after 12 weeks. Sample Size: It is calculated that a total of 20 patients per arm are needed so 120 patients in total.