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A randomized, double blind, cross-over trial to study the effects of adding bezafibrate to standard lipid lowering therapy on postprandial lipids in patients with Familial Dysbetalipoproteinemia

To evaluate the difference in the post fat load non HDL after an oral fatload between bezafibrate and placebo in patients with FD using standard lipid-lowering therapy

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…

A study to assess the anti-albuminuric effects and variability in response to dapagliflozin in subjects with type 2 diabetes

Primary Objective: To assess the change from baseline in 24-hr albuminuria with dapagliflozin for six weeks relative to placebo treatment in patients with diabetes and albuminuria > 100 mg/day on stable ACEi or ARB treatment.Secondary…

OpT2mise glucose control in type 2 Diabetes Mellitus (DM) with insulin pump therapy

The purpose of this study is to evaluate the comparative the efficacy of insulin pump therapy versus multiple daily injections in insulin*taking type 2 DM who are sub optimally controlled with MDI.Primary objective: To evaluate between groups change…

The effect of short term Topiramate treatment on insulin secretion, glucose- and lipid metabolism in obese women

•To determine the effect of short-term Topiramate treatment on glucose metabolism including endogenous glucose production, whole body glucose disposal and glucose oxidation in obese women. •To determine the effect of short-term Topiramate on lipid…

Mechanisms of Albuminuria in Diabetes: Reversal of Injury to the Glycocalyx by the Ace-inhibitor Lisinopril

The primary objective of this study is to determine whether ACE inhibition results in an improvement of microvascular glycocalyx-thickness in patients with type 1 diabetes. The secondary objectives are to investigate whether this (hypothesized)…

Adjustment of insulin Degludec to Reduce post-Exercise (nocturnal) hypoglycaeMia in people with diabetes - the ADREM study

To examine the effect of two different degludec dose adjustments on glucose profiles and the incidence of (nocturnal) hypoglycaemia after oxidative exercise in people with DM1 at elevated risk of hypoglycaemia.

A multicenter, randomized, double-blind, placebo-controlled, crossover trial to evaluate the effects of evolocumab added to standard lipid-lowering therapy on fasting and post fat load lipids in patients with Familial Dysbetalipoproteinemia.

To evaluate the effect of 12 weeks subcutaneous evolocumab (140 mg pre-filled pen every 2 weeks) compared to placebo on post fat load non-HDL-C levels in 30 subjects with FD, in a multicenter, randomized, placebo-controlled, double-blind, crossover…

A TRIAL TO COMPARE THE INJECTION SITE PAIN EXPERIENCE OF SEMAGLUTIDE 0.25 MG AND DULAGLUTIDE 0.75 MG ADMINISTERED SC

The purpose of this study is to investigate if there is a difference in the injection site pain experience after an injection under the skin (subcutaneous) with 2 different products, semaglutide and dulaglutide, in healthy volunteers. The 2 products…

A single-center, prospective, placebo-controlled, double-blind, randomized, cross-over mechanistic intervention study to investigate the effect of empagliflozin on kidney function in people with either preserved or impaired kidney function with or without type 2 diabetes

We aim to investigate the renal hemodynamic effects of empagliflozin in people with either preserved or impaired renal function with T2DM and people with impaired renal function without T2DM, all with and without adenosine blockade.

A Prospective, Randomized, Double-Blind, Sham-Controlled, Multi-Center Pivotal Study to Evaluate the Efficacy and Safety of Duodenal Mucosal Resurfacing (DMR) Using the Revita® System in Subjects with Type 2 Diabetes on Insulin therapy

To assess the efficacy of Revita® DMR for improving HbA1c to <= 7% without the need of insulin in subjects with T2D compared to sham.To assess the efficacy of DMR versus Sham on improvement in Glycemic, Hepatic and Cardiovascular endpoints.

MAASFLEX: A Double-Blind, Randomized, Phase IV, Mechanistic, Placebo-Controlled, Cross-Over, Single-Center Study to Evaluate the Effects of 2 Weeks Dapagliflozin Treatment on Nocturnal Substrate Oxidation, Glucose Metabolism and Muscle Mitochondrial Function in Individuals with Impaired Glucose Homeostasis

The primary objective is to examine the effects of dapagliflozin on nocturnal substrate oxidation in overweight or obese subjects with disrupted glucose homeostasis but without T2D.

A phase 4, monocenter, prospective, randomized, placebo-controlled, double-blind, cross-over, mechanistic intervention trial to assess effect of 4-week Ertugliflozin (SGLT-2 inhibitor) therapy on renal (cortical and medullary) oxygenation as determined by BOLD-MRI and renal (cortical and medullary) oxygen consumption as determined by positron emission tomography (PET) using ¹¹C-acetate in patients with type 2 diabetes mellitus and healthy controls.

Despite multifactorial treatment approaches residual risk for the development and progression of DKD remains high and novel therapies to halt renal burden in T2DM are urgently needed. SGLT-2 inhibitors are a relatively recent additions to the…

DiEtary Sodium Intake effects on ertugliflozin-induced changes in GFR, reNal oxygenation and systemic hemodynamics: the DESIGN study, a randomized, placebo-controlled, cross-over study with ertugliflozin in people with type 2 diabetes

This study has been transitioned to CTIS with ID 2023-510257-42-01 check the CTIS register for the current data. Sodium-glucose cotransporter 2 (SGLT2) inhibitors lead to a lowering of blood pressure and confer cardiovascular and renal protection in…

Effect of oral magnesium supplementation on insulin sensitivity in people with type 2 diabetes

To investigate the effect of oral magnesium supplementation on insulin sensitivity in people with T2DM and a low serum magnesium concentration.

A phase 4, monocenter, randomized, double-blind, placebo-controlled, 4-armed cross-over mechanistic intervention study to assess the renal hemodynamic effect of mono- and combination therapy with empagliflozin (SGLT-2 inhibitor) and losartan (RAS inhibitor) in metformin and/or SU-treated patients with type 2 diabetes mellitus

Investigate the effects of 7 (+-1) days of of mono- and combination therapy with the SGLT2 inhibitor empagliflozin (10 mg QD) and RAS inhibitor losartan (50 mg QD) on renal hemodynamics, (glomerular filtration rate (GFR) / effective renal plasma…

Pharmacokinetic cross-over study of compounded chenodeoxycholic acid

To investigate the pharmacokinetics of hospital pharmacy compounded CDCA capsules, compared to the commercial alternative.

Effect of inhaled corticosteroid tapering in obese T2-low asthma patients on asthma control and quality of life: an investigator-initiated, multicenter, non-inferiority, open label crossover trial with open label extension

Primary Objective To demonstrate that ICS can be safely withdrawn in T2-low asthma patients with obesity in secondary care (i.e. without loss of asthma control).Secondary Objectives1. To determine predictive factors for successful ICS withdrawal.2.…

DAPAMAAST: A Double-blind, Randomized, Phase IV, Mechanistic, Placebo-controlled, Cross-over, Single-center Study to Evaluate the Effects of 5 Weeks Dapagliflozin Treatment on Insulin Sensitivity in Skeletal Muscle in Type 2 Diabetes Mellitus Patients

The aim of the study is to investigate effects of dapagliflozin on potential mechanisms explaining improved insulin sensitivity in skeletal muscles.