Repurposing Colchicine for Reduction of Residual Inflammatory Risk in Type 1 Diabetes: A Randomized, Double-blind, Placebo-controlled, Investigator-initiated Trial

The aim of this clinical trial is to evaluate if colchicine in addition to standard of care improves markers of inflammation and cardiovascular disease in persons with type 1 diabetes. Participants will be assigned to either 0,5 mg colchicine daily or placebo in a 1:1 ratio for 26 weeks.

开始日期2023-08-29

申办/合作机构

Gentofte University Hospital

[+2]

NCT05448274 / CompletedN/AIIT

An Intervention Study to Explore Potential Metabolic Effects of Ruminococcus Torques Strain ATCC 27756 in Healthy Adults

A randomized, placebo controlled crossover study investigating the potential metabolic effects of the naturally occurring gut microbe Ruminococcus torques in healthy, overweight adults.

开始日期2023-05-03

申办/合作机构

Gentofte University Hospital

[+3]

NCT05788601 / Active, not recruiting临床2期IIT

Dapiglutide for the Treatment of Obesity (DREAM): a Randomised, Double-blind, Placebo-controlled, Investigator-initiated Trial

This study is an investigator-initiated, proof-of-concept, randomised, double-blind, placebo-controlled, parallel-group, single-centre clinical trial investigating the body weight loss potential of dapiglutide, a dual GLP-1R/GLP-2R agonist, administered subcutaneously once weekly. The study will investigate the efficacy of once-weekly subcutaneously administered of 4 mg and 6 mg dapiglutide versus placebo in 54 obese individuals (BMI >30 kg/m2) during a 12-week treatment period.

开始日期2023-04-27

申办/合作机构

Gentofte University Hospital

[+1]

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项与 Gentofte University Hospital 相关的文献（医药）

2024-11-01·Journal of Infection

Time of day for vaccination, outcomes, and relative effectiveness of high-dose vs. standard-dose quadrivalent influenza vaccine: A post hoc analysis of the DANFLU-1 randomized clinical trial

Article

作者: Jensen, Anne Marie Reimer ; Gislason, Gunnar H ; Johansen, Niklas Dyrby ; Biering-Sørensen, Tor ; Landler, Nino Emanuel ; Køber, Lars ; Christensen, Jacob ; Claggett, Brian L ; Landray, Martin J ; Solomon, Scott D ; Harris, Rebecca ; Skaarup, Kristoffer Grundtvig ; Loiacono, Matthew ; Modin, Daniel ; Nealon, Joshua ; Jensen, Jens Ulrik Stæhr ; Larsen, Carsten Schade ; Samson, Sandrine ; Sivapalan, Pradeesh ; Janstrup, Kira Hyldekær

OBJECTIVESMorning influenza vaccination enhances antibody response. In this post hoc analysis of the DANFLU-1 trial, we sought to evaluate the association between time of day for vaccination (ToV) and outcomes and whether ToV modified the relative effectiveness of high-dose (QIV-HD) vs. standard-dose (QIV-SD) quadrivalent influenza vaccine.METHODSDANFLU-1 was a pragmatic feasibility trial of QIV-HD vs. QIV-SD. Outcomes included hospitalizations and mortality. For subgroup analysis, the population was dichotomized at median ToV into two groups (early and late).RESULTSThe study population included 12,477 participants. Mean age was 71.7 ± 3.9 years with 5877 (47.1%) female participants. Median ToV was 11.29 AM. Earlier ToV was associated with fewer respiratory hospitalizations independent of vaccine type, which persisted in adjusted analysis (IRR 0.88 per 1-hour decrement (95% CI 0.78- 0.98, p = 0.025). No effect modification by continuous or dichotomous ToV was found. In subgroup analysis, effects consistently favored QIV-HD against hospitalizations for pneumonia or influenza (early: IRR 0.30; late: 0.29), all-cause hospitalizations (early: IRR 0.87; late: 0.86), and mortality (early: HR 0.53; late: 0.50).CONCLUSIONIn this exploratory post hoc analysis, earlier ToV was associated with fewer respiratory hospitalizations. The relative effectiveness of QIV-HD vs. QIV-SD was not modified by ToV. Further research is needed to confirm findings.TRIAL REGISTRATIONClinicaltrials.gov: NCT05048589.

2024-09-01·Matrix Biology

The fibroblast hormone Endotrophin is a biomarker of mortality in chronic diseases

Review

作者: Karsdal, Morten A ; Hansen, Michael K ; Kremer, Daan ; Cockwell, Paul ; Bakker, Stephan Jl ; Shaker, Saher Burhan ; Sand, Jannie Marie Bülow ; Jenkins, R Gisli ; Nissen, Neel I ; Frederiksen, Peder ; Fahy, William A ; Vestbo, Jørgen ; Reese-Petersen, Alexander Lynge ; Bager, Cecilie ; Nanthakumar, Carmel ; Vazquez, Dario ; Wain, Louise V ; Rasmussen, Daniel Guldager Kring ; Hoyer, Nils ; Núñez, Julio ; Maher, Toby M ; González, Arantxa ; Zhao, Lei ; Genovese, Federica ; Molyneaux, Philip L ; Rossing, Peter ; Boisen, Mogens Karsbøl ; Leeming, Diana Julie ; Selby, Nicholas M ; Stewart, Iain D ; Chen, Inna M ; George, Jacob ; Schuppan, Detlef ; Trebicka, Jonel

Fibrosis, driven by fibroblast activities, is an important contributor to morbidity and mortality in most chronic diseases. Endotrophin, a signaling molecule derived from processing of type VI collagen by highly activated fibroblasts, is involved in fibrotic tissue remodeling. Circulating levels of endotrophin have been associated with an increased risk of mortality in multiple chronic diseases. We conducted a systematic literature review collecting evidence from original papers published between 2012 and January 2023 that reported associations between circulating endotrophin (PROC6) and mortality. Cohorts with data available to the study authors were included in an Individual Patient Data (IPD) meta-analysis that evaluated the association of PROC6 with mortality (PROSPERO registration number: CRD42023340215) after adjustment for age, sex and BMI, where available. In the IPD meta-analysis including sixteen cohorts of patients with different non-communicable chronic diseases (NCCDs) (N = 15,205) the estimated summary hazard ratio for 3-years all-cause mortality was 2.10 (95 % CI 1.75-2.52) for a 2-fold increase in PROC6, with some heterogeneity observed between the studies (I²=70 %). This meta-analysis is the first study documenting that fibroblast activities, as quantified by circulating endotrophin, are independently associated with mortality across a broad range of NCCDs. This indicates that, irrespective of disease, interstitial tissue remodeling, and consequently fibroblast activities, has a central role in adverse clinical outcomes, and should be considered with urgency from drug developers as a target to treat.

2024-08-01·European Respiratory Journal

Titration of anti-IL-5 biologics in severe asthma: an open-label randomised controlled trial (the OPTIMAL study)

Article

作者: Lock-Johansson, Sofie ; Soendergaard, Marianne Baastrup ; Hilberg, Ole ; Hansen, Susanne ; Bjerrum, Anne-Sofie ; von Bulow, Anna ; Rasmussen, Linda Makowska ; Porsbjerg, Celeste

BackgroundAnti-interleukin (IL)-5 biologics effectively reduce exacerbations and the need for maintenance oral corticosteroids (mOCS) in severe eosinophilic asthma. However, it is unknown how long anti-IL-5 treatment should be continued. Data from clinical trials indicate a gradual but variable loss of control after treatment cessation. In this pilot study of titration, we evaluated a dose-titration algorithm in patients who had achieved clinical control on an anti-IL-5 biologic.MethodsIn this open-label randomised controlled trial conducted over 52 weeks, patients with clinical control (no exacerbations or mOCS) on anti-IL-5 treatment were randomised to continue with unchanged intervals or have dosing intervals adjusted according to a titration algorithm that gradually extended dosing intervals and reduced them again at signs of loss of disease control. The OPTIMAL algorithm was designed to down-titrate dosing until signs of loss of control, to enable assessment of the longest dosing interval possible.ResultsAmong 73 patients enrolled, 37 patients were randomised to the OPTIMAL titration arm; 78% of patients tolerated down-titration of treatment. Compared to the control arm, the OPTIMAL arm tended to have more exacerbations during the study (32%versus17%; p=0.13). There were no severe adverse events related to titration, and lung function and symptoms scores remained stable and comparable in both study arms throughout.ConclusionThis study serves as a proof of concept for titration of anti-IL-5 biologics in patients with severe asthma with clinical control on treatment, and the OPTIMAL algorithm provides a potential framework for individualising dosing intervals in the future.

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