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Prevent CardioKids

The aim of Prevent CardioKids is to evaluate to what extend disturbed vascular function markers are present in children of different weight categories and whether these are age dependent. Also differences * and relationships between * vascular…

Whole-body MRI in Gaucher disease; monitoring disease activity, early detection of complications and treatment decision-making

The objective of the study is to investigate the applicability of the whole body MRI protocol in Gaucher disease. To do so, we will investigate:1. If whole-body MRI ironmeasurements represent the distribution and total amoount of Gauchercells in the…

Acute Nutritional Ketosis in VLCAD Deficiency: testing the metabolic basis for therapeutic use

To test if acute NK boosts muscle mitochondrial function in vivo in patients with VLCADD in order to establish a rational basis for therapeutic use in this disorder. A secondary objective is to gather data to test the working hypothesis that the…

Brown adipose tissue activity and energy metabolism in cachexia induced by cancer or chronic disease

To study BAT activity and energy metabolism in patients with cachexia induced by cancer or chronic disease.

Intestinal production of Imidazole Propionate in healthy and obese subjects with or without DM2;
a pilot trial

To study the pharmacokinetics of non-reactive labelled histidine (L-HISTIDINE:HCL:H2O (D5, 98%; 15N3,98%) and the effect on intestinal imidazole propionate (IP)production in small intestine vs colon in healthy controls, metabolic syndrome and DM2…

Group rehabilitation for renal patients

The purpose of GRN-study is: 1. to determine the long-term effectiveness of a 12 weeks lasting physical exercise training program. 2. to determine the costeffectiveness of the 12 weeks lasting physical exercise training program. In aim of the GRN-…

A Study to Evaluate the Efficacy and Safety of GFT505 once daily on Steatohepatitis in Patients with Non-Alcoholic Steatohepatitis (NASH).
A Multicentre, Randomized, Double Blind, Placebo-Controlled study, with an adaptive design to allow for initial GFT505 80mg dosing versus placebo, followed by a second phase including GFT505 120mg dose, after review of 6-month safety analysis of the 80mg data on at least 50% of patients.

The primary objectives of this study are: - To evaluate the efficacy of GFT505 80mg and GFT505 120mg once daily (according to adaptive design, after 6-month interim safety analysis of the 80mg data on at least 50% of patients) for 52 weeks versus…

Adipokines gene expression in visceral adipose tissue in patients with esophageal adenocarcinoma

The purpose of this study is to investigate the role of adipokines-secretion in visceral adipose tissue and its influence on the risk for esophageal adenocarcinoma. Examination of adipose tissue may provide important insight into mechanistic links…

Nutrient sensing in response to starvation in obese and lean individuals

1. To compare the effects of fasting on energy sensing machinery in muscle of obese vs normal weight subjects2. To compare neuronal activity in the brain in response to fasting in obese vs normal weight humans3. To compare the activity of the HPA…

A Double-blind, Randomized, Multicenter Study to Evaluate Safety and Efficacy of AMG 145, Compared With Ezetimibe, in Hypercholesterolemic Subjects Unable to Tolerate an Effective Dose of a HMG-CoA Reductase Inhibitor (AMG 145 20110116)

Primary: To evaluate the effect of 12 weeks of subcutaneous (SC) AMG 145 every-2-weeks (Q2W) and every-4-weeks (Q4W), compared with ezetimibe, on percent change from baseline in low-density lipoprotein cholesterol (LDL-C).Secondary objectives:…

Macrophage infiltration and adipocytokine expression in subcutaneous and visceral fat tissue in patients with Cushing's syndrome.

To describe the differences in macrophage infiltration and mRNA expression of adipocytokines in subcutaneous, omental and perirenal fat tissue in Cushing's syndrome compared to healthy controls.

A Double-blind, Randomized, Placebo and Ezetimibe Controlled, Multicenter Study to Evaluate Safety, Tolerability and Efficacy of AMG 145 on LDL-C in Combination With Statin Therapy in Subjects With Primary Hypercholesterolemia and Mixed Dyslipidemia (AMG 145 20110115)

Primary: To evaluate the effect of 12 weeks of subcutaneous (SC) AMG 145 every-2-weeks (Q2W) and every-4-weeks (Q4W), compared with placebo, on percent change from baseline in low-density lipoprotein cholesterol (LDL-C).Secondary objectives: Safety…

Effects of a high-fat and a low-fat diet on early biomarkers of metabolic stress in blood and gene expression in the small intestine of healthy subjects

The objective of this study is to compare in healthy subjects the effects of a HF diet (40 En% fat) with those of a LF diet (20 En% fat) on early biomarkers and parameters of metabolic stress in blood and on expression of genes in the small…

A Randomized, Crossover, Pharmacokinetic and Pharmacodynamic Study to Determine the Safety and Efficacy of Cysteamine Bitartrate Delayed-release Capsules (RP103), Compared to Cystagon® in Patients with Nephropathic Cystinosis

The objective of this pivotal study is to assess the PK and PD as well as safety and tolerability of RP103 compared to Cystagon® in patients with nephropathic cystinosis. Results of this Phase 3 study will be used to support the registration…

Impact of microbial communities on obesity

The aim of this study is to test the hypothesis that obesity and the microbial community in the human GI tract are linked

Effects of fenofibrate and fish oil on gene expression and metabolic changes in obese subjects

The objective of this study is to compare in obese subjects the effects of fenofibrate (200 mg/day) with those of fish oil (7.2 g/day) on expression of PPARα related genes and metabolic parameters.

Effect of prebiotic fibres on Intestinal Health and Functioning

To study effects of AXOS (1) on gut health including among other parameters intestinal transit time, fecal cytotoxicity, pH, inflammatory markers, short-chain fatty acids and microbiota composition), gut permeability and gut functioning (bloating,…

Effect of Fecal microbiotA Transplantation combined with MEditerranean Diet on insulin sensitivity in subjects with metabolic syndrome

To study the effect of a Mediterranean diet (MD) followed by lean donor fecal microbiota transplantation (FMT) versus the prescription of Mediterranean diet (MD) followed by autologous (own) FMT in male subjects with metabolic syndrome on peripheral…

A phase 1, randomized, double-blind, placebo-controlled, single-site study to assess the safety, tolerability, pharmacokinetics and food effect of MIN-102 following oral administration of single and multiple ascending doses in healthy male volunteers

The purpose of the study is to investigate to what extent MIN-102 is tolerated.It will also be investigated how quickly and to what extent MIN-102 is absorbed and eliminated from the body (this is called pharmacokinetics). In addition, the effect of…

A Randomized, Double-Blind, Placebo-Controlled Study of the Safety and Efficacy of Varying Doses and Dose Regimens of Evinacumab in Patients with Persistent Hypercholesterolemia Despite Maximally Tolerated Lipid Modifying Therapy

The primary objective of the study is to evaluate the reduction of low density lipoprotein cholesterol (LDL-C) by evinacumab in comparison to placebo after 16 weeks in patients with primary hypercholesterolemia (heterozygous familial…