Fenofibrate in the management of AbdoMinal aortic anEurysm (FAME): study protocol for a randomised controlled trial

Abstract

BackgroundAbdominal aortic aneurysm (AAA) is a slowly progressive destructive process of the main abdominal artery. Experimental studies indicate that fibrates exert beneficial effects on AAAs by mechanisms involving both serum lipid modification and favourable changes to the AAA wall.Methods/designFenofibrate in the management of AbdoMinal aortic anEurysm (FAME) is a multicentre, randomised, double-blind, placebo-controlled clinical trial to assess the effect of orally administered therapy with fenofibrate on key pathological markers of AAA in patients undergoing open AAA repair. A total of 42 participants scheduled for an elective open AAA repair will be randomly assigned to either 145 mg of fenofibrate per day or identical placebo for a minimum period of 2 weeks prior to surgery. Primary outcome measures will be macrophage number and osteopontin (OPN) concentration within the AAA wall as well as serum concentrations of OPN. Secondary outcome measures will include levels of matrix metalloproteinases and proinflammatory cytokines within the AAA wall, periaortic fat and intramural thrombus and circulating concentrations of AAA biomarkers.DiscussionAt present, there is no recognised medical therapy to limit AAA progression. The FAME trial aims to assess the ability of fenofibrate to alter tissue markers of AAA pathology.Trial registrationAustralian New Zealand Clinical Trials Registry, ACTRN12612001226897. Registered on 20 November 2012.Electronic supplementary materialThe online version of this article (doi:10.1186/s13063-016-1752-z) contains supplementary material, which is available to authorized users.

Fenofibrate and Telmisartan in the Management of Abdominal Aortic Aneurysm

“…FAME and FAME-2 are multi-centre, randomized, double-blind, placebo controlled trials which have recently been described in detail elsewhere [54,55]. FAME looks to examine the effect of 145mg of fenofibrate taken daily for a minimum of 2 weeks in 42 participants scheduled for an elective open AAA repair.…”

The Effectiveness of Internet-Based Cognitive Behavioral Therapy in Treatment of Psychiatric Disorders

“…ICBT apps and programs should also include adequate security features to protect patient data, a domain that requires further research [ 23 ]. Most ICBT apps include pre- and post-use surveys in the form of questionnaires and also check-ins with the therapist in the form of email or weekly sessions [ 1 ]. ICBT can also be used to determine specific risk factors that contribute to psychiatric disorders [ 24 - 25 ].…”

“…With technological advances and its integration with healthcare, it has become a fast-growing intervention channel compared to conventional psychotherapy. ICBT is used to manage various psychiatric disorders such as mild to moderate depression and other disorders such as anxiety, obsessive compulsive disorder (OCD), and panic disorder [ 1 - 3 ]. ICBT has also been used to treat patients who have chronic illnesses such as diabetes with comorbidities such as depression and in those who received intensive care and had developed post-traumatic stress disorder (PTSD) [ 4 - 5 ].…”

“…In this article, we concentrate on the growing potential of ICBT in the management of various psychiatric disorders and its efficacy in patient care. Therapist-guided ICBT involves checking in with the therapist via emails or weekly online sessions [ 1 ]. Self-guided ICBT requires the patient to use an app or an internet program such as 'MoodHacker' or 'e-Ouch' [ 8 ].…”

Simultaneous Natural Deep Eutectic Solvent-Based Ultrasonic-Assisted Extraction of Bioactive Compounds of Cinnamon Bark and Sappan Wood as a Dipeptidyl Peptidase IV Inhibitor

“…Some studies have revealed that sappan and cinnamon have beneficial effects on diabetes mellitus [ 5 , 6 ]. Sappan wood works through the mechanism of α-glucosidase and DPP IV inhibition, as well as inhibition of gluconeogenesis and hepatic glycolysis [ 5 , 7 , 8 ]; whereas cinnamon works through the mechanism of activating glucose transporter type-4 (GLUT-4) and α-glucosidase inhibition [ 9 , 10 ].…”