Background

For the last few years, one of the hottest topics in clinical research has been data integrity. An important part of ensuring data integrity - that is now mandated by the authorities - is the structured review of audit trails. Unfortunately, there is little guidance on how to perform such review. As it is virtually impossible to read all lines in an audit trail (and it would not make much sense either), other means of review need to be applied.
The solution for this problem is visual data analytics. We have created an interactive environment that enables the reviewer to dig into the data and learn what actually happened during a study. With this novel approach, audit trail review not only becomes possible, but it actually becomes meaningful.

Profil continues the successful series of scientific online seminars. On March 23th, 2021 at 4 PM CEST we will air our next free online seminar. The session is presented by Sascha Heckermann, Chief Executive Officer at Profil. 

The β₃‐adrenoceptor (β₃-AR) was initially an attractive target for several pharmaceutical companies due to its high expression in rodent adipose tissue, where its activation resulted in decreased adiposity and improved metabolic outcomes in animal models of obesity and type 2 diabetes. Despite the expression of β₃-AR in human brown and white adipocytes, urinary bladder and potentially other tissues [1, 2, 3], the translation of rodent studies to humans was cumbersome as several drugs acting on the β₃-AR failed in achieving weight loss targets.

A substantial amount of studies in the last decade have determined the detrimental effects of overweight and obesity on the risk of myocardial infarction, stroke, cancer, and overall mortality. Nonetheless, there is also evidence in favour of the so-called “obesity-paradox” which states that overweight - or even obesity - exerts a protective role or has no impact on the incidence of cardiovascular disease (CVD) and overall mortality, because of increased cardiovascular mortality in the lowest BMI strata (J-curve).

In March 2018, a study was published by researchers from the University of Glasgow, challenging the obesity-paradox and heating up the debate of this much-discussed topic [1].

Glucagon-like peptide receptor (GLP-1R) agonists are an established treatment option for type 2 diabetes. In addition to their blood glucose lowering effect (with a low risk of hypoglycaemia) they also promote weight loss. With the approval of liraglutide 3.0 mg/wk last year, a GLP-1R agonist is now also available for the treatment of obesity.

SUSTAIN 7 was an open-label, parallel-group, phase 3b trial at 194 sites in 16 countries investigating GLP-1R agonists semaglutide and dulaglutide [1]. Participants were 18 years and older and had type 2 diabetes with an HbA_1c of 7.0-10.5% on metformin therapy (n=1201). Patients were assigned to either semaglutide 0.5 mg, dulaglutide 0.75 mg, semaglutide 1.0 mg or dulaglutide 1.5 mg. The study medication was injected once weekly for 40 weeks. Primary endpoint was change from baseline in HbA1c; the confirmatory secondary endpoint was change in bodyweight, both after 40 weeks of treatment. 

Is alternate-day fasting regimes the new trend?

Alternate-day fasting regimens have gained particular popularity in the last decade. The strategy of alternate-day fasting is to implement a fasting day, where individuals consume only 25% of their calories (approximately 500 kcal). The fasting day alternates with a “feast” day (every other day) where foods and liquids can be consumed ad libitum.

The idea behind is to eat the way our ancestors did – who had a life expectancy of 35 years without obesity and heart attacks – and the hope to lose weight with a diet which is said to be easier to stick to than traditional, everyday calorie restriction diets.