Conectar
by Simon Söderholm, Martin Ulander, Vanessa William Toma, Sara Kaufmann, Xiangyu Qiao, Daniel Berglind, Susanna Calling, Bledar Daka, Ludger Grote, Mats Martinell, Frida Bergman, Pontus Henriksson, Carl-Johan Östgren, Wen Zhong, Claudio Cantù, Fredrik Iredahl
Coffee is the most common drink in the world, second only to water. This makes caffeine, the ingredient of coffee known for its wakefulness-promoting effects, one of the most used psychoactive substances. The psychoactive property of caffeine is well-characterized, and entails its interaction with the adenosine receptors, involved in sleep regulation. While studies have shown a deleterious immediate effect of caffeine on sleep, less is known about the effects of chronic caffeine exposure. In the present cross-sectional study, we investigated this relationship across a large cohort of 30,154 individuals participating in the Swedish Cardiopulmonary Bioimage Study (SCAPIS), which allowed us to compare habitual coffee intake with sleep habits, subjective estimate of daytime sleepiness, and underlying genetic variants. According to our analyses, different degrees of coffee consumption, confirmed by statistical association with previously reported genetic variants, showed very low association with estimated patterns of sleep habits or perceived daytime sleepiness. These results indicate that coffee may be less impactful on sleep habits than previously thought, or that other mechanisms, such as the adaptive capabilities of the adenosine system in adult coffee users, may dampen its psychoactive potency.Pre-eclampsia and fetal growth restriction are leading causes of perinatal morbidity and mortality. A therapy that enhances maternal vascular function and promotes vasodilation to increase placental perfusion could treat both conditions.
Tissue kallikrein-1 is an endogenous enzyme that releases bradykinin to activate the bradykinin 2 receptor on endothelial cells. This induces potent vasodilation and pro-angiogenic, anti-oxidant and anti-inflammatory effects.
DM199 is a recombinant form of tissue kallikrein which can be administered intravenously or subcutaneously. Clinical trials in non-pregnant populations have demonstrated its safety. Being a protein, it is unlikely to cross the placenta. This protocol describes an early-phase trial for DM199 for pre-eclampsia and fetal growth restriction.
This phase IB/IIA open-label trial at Tygerberg Hospital, Western Cape Province, South Africa, will determine the safety and effective dose of DM199 for pre-eclampsia and/or fetal growth restriction. The trial consists of two parts. Part 1 will be an ascending dose finding study, treating women with pre-eclampsia and severe hypertension who are for planned birth within 72 hours. This will search for doses that safely lower blood pressure (n=3/dose, recruiting up to 42 participants). Part 2 is a safety and efficacy study of three cohorts of pregnant women (n=30/cohort): (1) with pre-eclampsia and severe hypertension requiring delivery within 72 hours, (2) with preterm pre-eclampsia (
The trial has ethical approval (Health Research Ethics Committee, Stellenbosch University, Protocol number M24/04/009) and is registered (Pan African Clinical Trial Registry, PACTR202404895013782) and approved by the South African Health Products Regulatory Authority (20240801). Data will be presented at international conferences and published in peer-reviewed journals.
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