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A Single-Dose, Open-Label, Randomized, 4-Way Crossover Pivotal Study to Assess the Bioequivalence of Canagliflozin when Administered as the Monohydrate form to the Hemihydrate form in Healthy Adult Subjects under Fasted Conditions

The purpose of this studie is to evaluate the bioequivalence of canagliflozin.

Changing neural processing of olfactory and visual food cues by sensory specific satiety

With the current study we aim to assess early brain responses to different food cues (odours and pictures) and we want to determine how these responses are affected by ad libitum intake of product with a specific flavor (sweet/savoury). We expect to…

The effect of intravenous lactate administration on brain lactate concentrations and pH during euglycemia and hypoglycemia in patients with type 1 diabetes with and without impaired awareness of hypoglycemia

This project consists of two related studies. The objective of part 1 is to investigate the effect of elevated plasma lactate levels that are sufficient to impair awareness of hypoglycemia on brain lactate concentrations during euglycemia and…

Acute Nutritional Ketosis and Exercise in Glycogen Storage Disease type IIIa.

To investigate the potential of a novel dietary substrate preparation to enhance muscle mitochondrial function in GSD IIIa via acute nutritional ketosis. Secondary objectives are to further investigate in vivo exercise tolerance and intramuscular…

TRIUMPH-2: Trientine dihydrochloride (Syprine® capsules) vs. tetrahydrochloride (tablets): a Phase 1, single center, randomized, interventional, open-label, 4-way crossover study in adult healthy male and female subjects to evaluate the pharmacokinetics and the safety and tolerability of 2 different oral formulations.

The primary objective of this study is to evaluate and compare the plasma PK parameters of TETA and its two metabolites (MAT and DAT) after two dose levels of Syprine® capsules and TETA 4HCL tablets in adult healthy male and female volunteers.The…

A phase IV, randomized, double-blind, placebo-controlled, parallel-group trial to assess the effect of 12-week treatment with the glucagon-like peptide-1 receptor agonist (GLP-1RA) liraglutide or dipeptidyl peptidase-4 inhibitor (DPP-4i) sitagliptin on the cardiovascular, renal and gastrointestinal system in insulin-naïve patients with type 2 diabetes (T2DM).

Overarching Aim: to detail the (mechanisms underlying the) actions of GLP-1RA and DPP-4i on the cardiovascular, renal and gastrointestinal system patients with T2DM. For the sake of clarity, we divide the study objectives into 3 parts:Primary…

MAINTAINING HEALTH IN OLD AGE THROUGH HOMEOSTASIS Phase II

To identify which brain regions are activated after intranasal application of insulin and how this affects peripheral metabolism.

Validation of Treating to Non-Fasting Lipid Targets in Comparison to Fasting Lipid Targets

To investigate the accuracy of non-fasting lipid profiles versus fasting lipid profiles when lipid lowering therapy is aimed at recommended lipid treatment targets.

The effect of L-arginine on brown adipose tissue metabolism in South Asian and white Caucasian subjects

In this study, we will investigate the influence of the amino acid L-arginine, which enhances release of nitric oxide in the body, on BAT activity and metabolism in healthy subjects with overweight. This will increase understanding on the effect of…

THE EFFECTS OF REAL-TIME CONTINUOUS GLUCOSE MONITORING ON GLYCEMIA AND QUALITY OF LIFE IN PATIENTS WITH TYPE 1 DIABETES MELLITUS AND IMPAIRED HYPOGLYCEMIA AWARENESS

Primary objective: To assess the mean difference in time spent in the euglycemic range (interstitial glucose >3.9-<10.0 mmol/L), expressed as hours/day, between the two 16-week intervention periods, i.e. RT-CGM versus masked CGM, in…

Undercarboxylated osteocalcin, the hypothalamic-pituitary-gonadal axis and glucose metabolism in male patients with osteoporosis.

The objective of the study is to study the effect of Teripratide (rhPTH 1-34) on undercarboxylated osteocalcin levels, testosterone concentrations, glucose tolerance and insulin sensitivity in male subjects with primary osteoporosis.

Assessment of Hybrid Use of an Artificial Pancreas in a Home setting for Two Months in Patients with Type 1 Diabetes - DiAs Hybrid Home Trial

The objective is to test, validate, obtain regulatory approval for, and deploy at home, a closed-loop Control-to-Range (CTR) system comprising two algorithmic components: a Safety Supervision Module (SSM) and an automated Range Correction Module (…

The effect of low intensity physical activity on insulin sensitivity; an exploratory study into a possible link between insulin sensitivity and mood and cognitive performance

To assess the effect of low intensity physical activity on plasma insulin levels, cognition and mood in subjects with overweight/obesity

A drug-drug interaction study between the novel anti-HCV agent DAclatasvir and The antidiabetic agent mEtformine in healthy volunteers.

Primary objective:•To assess the effect of multiple dose daclatasvir (60mg QD) on the pharmacokinetics (AUC, Cmax, Ctrough, CLr) of multiple dose metformin (1,000mg BID) by intra-subject comparison, in healthy subjects.Secondary objective:•To assess…

Effects of moderate intermittent hypoxia exposure on peripheral insulin sensitivity and substrate metabolism in humans

The current research proposal intends to study the therapeutic potential of moderate intermittent hypoxia (IH) exposure in subjects at high risk of developing type 2 diabetes, and aims to address the following key objectives:1) To investigate the…

TRIENTINE DIHYDROCHLORIDE VS. TETRAHYDROCHLORIDE: A PHASE 1, SINGLE CENTER, RANDOMIZED, INTERVENTIONAL, SINGLE DOSE, OPEN-LABEL, CROSSOVER STUDY IN ADULT HEALTHY MALE AND FEMALE SUBJECTS TO EVALUATE THE PHARMACOKINETICS AND THE SAFETY, TOLERABILITY OF TWO DIFFERENT ORAL FORMULATIONS

The principal aim of this study is to evaluate the PK parameters of both oral formulations in adult healthy volunteers in order to propose forMarketing Authorization Application an adequate strength for TETA•4HCl (i.e. a strength providing a PK…

The effect of breakfast test products on acute satiety scores in different test conditions.

The primary objective is to investigate the acute effect of five different breakfast test products (breakfast cereals or bread or traditional) on satiety scores (feelings of hunger, fullness, satiety, desire to eat, prospective food consumption). -…

Influences of odors on appetite responses, food preferences and intake

To determine appetite responses to different odors (signalling different food products), measured by appetite questionnaires, a food preference task, saliva production and food intake

Factors in Accuracy Studies Influencing Measured Continuous Glucose Monitoring system (CGM) Performance: a comparison of measured continuous glucose monitor performance using venous, arterialized-venous and capillary reference glucose samples.

Primary objective: Assessment of the impact of the reference glucose measurement on the measured performance of a CGM system, comparing regular venous and arterialized-venous reference glucose samples.Secondary objective: - Assessment of the impact…

Effect of different protein diets on glucose and insulin metabolism and substrate partitioning

The presently proposed study aims to investigate how dairy proteins compare to vegetable protein and carbohydrate sources leads to glucose and insulin metabolism and substrate partitioning.