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454 active trials for Diabetes Mellitus - Type 2

Effect of Broccoli Sprout Extract in Patients With Chronic Kidney Disease With Diabetes Type 2

This research project aims to test if sulforaphane, administered as broccoli sprout extract (BSE) can ameliorate glucose control in adult patients with chronic kidney disease (CKD) and DM 2 with GFR > 15 < 45 ml/min/1.73 m2. The glucose control will be evaluated by the oral glucose tolerance test. Moreover, as a secondary aim, we will investigate the role of sulforaphane in improving other signs of metabolic derangements present in this group of patients, including oxidate stress, proteinuria, inflammation and a decrease in the production of uremic toxins from the gut microbiota. This a multicentre randomized double-blinded controlled trial including 100 adult patients with CKD and glomerular filtration rate (GFR) between 15 and 29 ml/min/1.73m2, DM type 2, age > 18 years old. Patients will be randomized into BSE group or Placebo group. Both groups will be followed for 20 weeks: The first 12 weeks patients will receive the BSE or Placebo and, the next 8 weeks, both groups will be followed with no intervention to observe the changes in the primary and secondary outcomes. Patients randomized to BSE Group will receive 50 µmmol/day of sulforaphane administered as BSE (Lantmännen®) from week 0 to week 4. If no side-effects are reported, the sulforaphane dose will increase to 100 µmmol/day from week 5 to week 8 and in the absence of side-effects, the dose will increase to 150 µmmol/day from week 9 to week 12. Blood and urine samples and OGTT (in non-insulin dependent patients) will be performed at week 0, 12 and 20. On week 4 and 8 blood drawn for partial exam will be performed. The BSE and the placebo (maltodextrin sprayed with copper-chlorophyllin) will be administered as powder provided in a double-blind manner as dry mixtures in sealed portion size bags of similar shape and size. Randomization will be done using a computer-based block randomization algorithm. Comparisons between the primary and secondary studied variables will be done with two-way analysis of variance (ANOVA) with repeated measures for normally distributed variables. Variables that can interfere with the glycemic control, such as changes in the dosage of hypoglicemiants agents and insulin during the intervention will be controlled in the analysis. Those non-normally distributed will be log transformed aiming to normalize the distribution. All test will consider a P<0.05 for statistical significance. The software Stata will be used for the statistical analysis.

Start: September 2021
EDUCATION TO DECREASE IN SODIUM INTAKE EVALUATED WITH 24 HOUR URINARY SODIUM EXCRETION(RCT)

WHO identifies as an important risk factor and potentially modifiable to high sodium intake (>2g/day 5g salt/day). Also, an insufficient consumption of potassium ( 3.5 g/day).Therefore, the results of this research could be the regional basis that is required to generate evidence, that designs strategies and recommendations for the prevention or decrease in the progression of high blood pressure. The reduction in the consumption of salt in the diet could comply with the recommendations established by international agencies. In addition, to favor the beginning of lifestyle changes, as well as other modifications that will have a positive impact on health.In population highly vulnerable to the campaigns of large industries that favor the consumption of processed food. However, it is unknown what is the effect of reducing foods high in sodium in populations in different regions of Mexico, estimated by 24 hour urine sodium excretion. Therefore, the present study aims to answer the following questions: What impact does an intervention aimed at the decrease in sodium intake, in young university students on blood pressure and the quantification of the excretion of sodium and urinary potassium of 24h? What is the association between body mass index, blood pressure and sodium reduction in the intervention vs control group? To assess the impact of an intervention aimed at reducing sodium intake through education as general recommendations for limiting specific foods high in sodium, in university students on blood pressure and quantification of urinary sodium and potassium excretion of 24h. Specific objectives Assess sodium intake between the intervention group and the control group by estimating 24-hour urinary sodium excretion. secundary objectives Evaluate the effect between the intervention group and the control group on blood pressure. To assess the levels of potassium excretion in the intervention and control groups. To evaluate the association between body mass index, blood pressure and sodium reduction in the intervention and control groups.

Start: October 2020
Research Study Comparing New Tablets of Semaglutide in New Doses, in Healthy People

In this study a known investigational medicinal product called semaglutide will be tested in four different tablet versions. In addition to semaglutide, the different tablet versions C, D, E and F contain different helping agents in different amounts. All tablet versions have a helping agent called SNAC. All tablet versions are tested for the treatment of type 2 diabetes. Recently the European Medicines Agency approved semaglutide in tablet form and currently, tablets in the doses 3 mg, 7 mg and 14 mg can be prescribed in some countries. The main aim of this study is to test oral semaglutide doses of 25 mg and 50 mg. These are higher dosages of oral semaglutide than can be prescribed today. With the 50 mg dose, we expect the amount of semaglutide in the blood to be higher than what has been tested before. Further aims of this study are to find an optimal version for the semaglutide tablets, and to examine the safety and tolerability of the different tablet versions. For this purpose, the amount of semaglutide in the blood will be measured after taking different semaglutide tablets, in different doses. The version of the tablet participants will receive (i.e. the treatment arm participants will be assigned to) is decided by chance. In treatment periods 1 and 2 participants will receive one tablet daily over 2 weeks for each period. For treatment periods 3 to 5 participants will receive one tablet daily over 4 weeks for each period (participants may get 2 tablets per day in treatment period 5). This means that treatment will take 16 weeks in total. The tablets should be taken in the morning together with no more than half a glass of water (120 mL), after an overnight fast of at least 6 hours (no food or drinks). Water is also not allowed from 2 hours before dosing. After dosing participants must wait 30-35 minutes before they eat or drink. At home, participants must take their breakfast 30-45 minutes after dosing. No oral medication (which are taken by mouth) can be taken from 2 hours before and until 30 minutes after each dosing with semaglutide. The study can last for up to 24 weeks for each participant. This includes a screening period (up to 3 weeks), a treatment period (16 weeks) and a follow-up visit (5 weeks after the last dosing). Participants will have 11 clinic visits with the study doctor. Some of the visits include overnight stays. Participants will have blood tests at every visit. Participants must be healthy and have a body mass index (BMI) between 21.0 and 29.9 kg/m^2 For women: Women cannot take part in this study if they are pregnant, breast-feeding or plan to become pregnant during the study period.

Start: September 2020