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An advanced configuration (the third generation) of the DIAMOND System for the treatment of T2DM patiënts- A randomized double blind study "Ruby Study".

In previous studies, the chronic effect, up to 6 months, of the one gastric lead continuous stimulation was demonstrated resulting in an improvement in blood glucose levels. The present hypothesis is that this effect is mediated by either a…

effect of Donor Intestinal Microbiota Infusion on residual betacell function in patients with recently diagnosed Diabetes mellitus type 1 ; the DIMID1-trial

to investigate whether microbial transplantation from either allogenic (healthy) or autologous (own) donor, administered through a small intestinal tube, has beneficial effects on immune status, betacell function c-peptide secretion upon mixed meal…

Effect of Fecal Transplantation on Satiety, Sarcopenia, Inflammation and Chemotherapy Toxicity in patients with Metastasized Oesophageal and Gastric Cancer.

Primary objective:Effect of fecal transplantation (from healthy obese donors) on faecel microbiota composition in relation to satiety (questionnaires, biomarkers) and metabolism (REE ) in patients with metastasized or locally advanced oesophageal or…

A multicentre, international, randomised, parallel group, double blind study to evaluate Cardiovascular safety of linagliptin versus glimepiride in patients with type 2 diabetes mellitus at high cardiovascular risk. The CAROLINA Trial.

CAROLINA studyThe aim of the present study is to investigate the long*term impact on CV morbidity and mortality and relevant efficacy parameters (HbA1c, fasting plasma glucose, treatment sustainability) of treatment with linagliptin in a relevant…

Efficacy and Safety of Continuous Subcutaneous Insulin Infusion of Faster-acting Insulin Aspart compared to NovoRapid® in Adults with Type 1 Diabetes.

To confirm the effect of continious subcutaneous insulin infusion (CSII treatment) with faster-acting insulin aspart in terms of glycaemic control by comparing it to CSII treatment with NovoRapid®, in adults with Type 1 diabetes Mellitus, using a…

A multicenter, randomized, double-blind, double-dummy, parallel-group, active-controlled study to evaluate the efficacy and safety of finerenone compared to eplerenone on morbidity and mortality in patients with chronic heart failure and reduced ejection fraction after recent heart failure decompensation and additional risk factors, either type 2 diabetes mellitus or chronic kidney disease or both.

Demonstrate the superiority of finerenone to eplerenone in delaying time to first occurrence of the compositeendpoint, defined as cardiovascular (CV) death or hospitalization for heart failure (HF), in patients withCHF (NYHA class II-IV) and reduced…

A placebo-controlled trial of insulin therapy with or without adjuvant metformin in patients with Cystic Fibrosis-Related Diabetes

Investigate the effect of adjuvant metformin therapy on insulin need and on glycaemic control in CFRD patients.

Protocol I2R-MC-BIAO;
The Impact of LY2605541 versus Insulin Glargine for Patients with Type 1 Diabetes Mellitus Treated with Preprandial Insulin Lispro: a Double-Blind, Randomized, 52 Week Study ;The IMAGINE 3 Study;

The primary objective is to demonstrate that glycemic control, as measured by hemoglobin A1c(HbA1c) at 52 weeks for LY2605541 is noninferior to insulin glargine, when each is combined with preprandial insulin lispro, in patients with type 1 diabetes…

Protein and lifestyle intervention to preserve muscle mass in obese older type 2 diabetes patients - a 13-week randomised, controlled exploratory study with a 24-week follow-up period.

Primary: To investigate the effect on leg muscle mass in the test group compared to the control group in older obese type 2 diabetes patients after 13 weeks of interventionSecondary: - To investigate the effect on glycemic control in the test group…

Effect of donor human milk on severe infections and mortality in VLBW infants, a double blind randomized controlled trial

To determine whether (supplemental) human donor milk has beneficial effects (in terms of reduction of infectious episodes and mortality) when compared to (supplemental) preterm formula during the first 10 days of life in VLBW infants. Amendement ESS…

A Randomised, double-blind, controlled trial to evaluate the effects of a micronutrient-fortified Growing Up Milk on the micro-nutrient status of young children

The objective of this study is to investigate the effect of a micronutrient-fortified GUM given for 20 weeks on the iron and vitamin D status of healthy 12-36 month old children in comparison to the control product.

The Most Effective Treatment Strategy for Diabetic Macular Edema.

To demonstrate that combined (repeated) laser photocoagulation prolongs time to failure compared to anti-VEGF monotherapy.

A randomized, double-blind, parallel group study to evaluate metabolic effects of LCZ696 and amlodipine in obese hypertensive subjects: the CLCZ696B2207 study

The objective of this study is to investigate what the effects of LCZ696 or amlodipine are on insulin sensitivity as assessed by hyperinsulinemic euglycemic glucose clamp (HEGC) after 8 weeks of treatment. Furthermore, the effects on subcutaneous…

Effects of alpha-linolenic acid on 24h-ambulatory mean arterial pressure in untreated high-normal and stage I hypertensive subjects

To study the effects of flaxseed oil, rich in ALA on 24h-ambulatory mean arterial pressure (MAP) in men and women with high-normal blood pressure and mild hypertension compared to high oleic sunflower oil, poor in ALA.

Effects of stearidonic acid on serum triacylglycerol concentrations in overweight and obese subjects

To study the effects of echium oil, rich in SDA on serum triacylglycerol concentrations in healthy overweight and slightly obese men and women. The minor objective is to study the effects of echium oil on the omega-3 index, which is negatively…

DALI: Vitamin D and Lifestyle Intervention for GDM Prevention: dosing study

The overall aim of the DALI study is to identify the best available measures to prevent GDM in an ongoing pregnancy, to provide a cost-benefit calculation of GDM prevention for health care systems, and to establish a pan-European cohort of mother-…

A Randomized, Double-Blind, Active-Controlled, Multicenter Study to Evaluate the Efficacy, Safety, and Tolerability of Canagliflozin Versus Sitagliptin in the Treatment of Subjects With Type 2 Diabetes Mellitus With Inadequate Glycemic Control on Metformin and Sulphonylurea Therapy

In subjects with T2DM with inadequate glycemic control on combination therapy withmetformin and an SU:Primary:* To assess the effect of the addition of treatment with canagliflozin compared with theaddition of treatment with sitagliptin on HbA1c…

A randomised, double-blind study evaluating the safety, tolerability, protein accretion, amino acid plasma levels and long-term outcome of Neoven compared to Vaminolact in premature very low birth weigth (VLBW) infants.

To evaluate the safety, tolerability, protein accretion, amino acid plasma levels and long-term outcome of Neoven compared to Vaminolact in preterm infants with a birth weight from 800 g to less than 1500 g and with a gestational age from 25 weeks…

FATLOSE 2 study *Single versus multiple fecal transplants harvested from lean volunteers on lipid and glucose metabolism in subjects with metabolic syndrome; the FATLOSE 2 trial (Fecal Administration To LOSE insulin resistance)*

In this follow-up study we would like to compare the effect of single versus multiple (2x) duodenenal tube infused allogenic versus autologous feces (as controls) on insulin resistance, cholesterol and (shortchain) free fatty acid metabolism in…

Impact of carbohydrate co-ingestion on the post-prandial anabolic response of protein in young and elderly men

The primary objective of the study is to investigate whether carbohydrate co-ingestion augments the in vivo postprandial muscle protein synthetic response after protein ingestion and whether this response is differs between young and elderly…