SGLT2i on cardiac autonomic, cardiometabolic and endothelial function
Research type
Research Study
Full title
ISAAC - Impact of Sodium-Glucose Co-Transporter 2 inhibitors (SGLT2i) on Cardiac Autonomic Function, Arrhythmias, Cardiometabolic regulation - A Proof-of-Concept study in patients with Type-2 Diabetes Mellitus and Heart Failure.
IRAS ID
335639
Contact name
Faizel Osman
Contact email
Sponsor organisation
UHCW
Duration of Study in the UK
1 years, 4 months, 1 days
Research summary
Sodium-glucose co-transporter 2 inhibitors (SGLT2i) have been shown to reduce Major Adverse Cardiac Outcomes (MACE) as well as cardiac mortality in large trials involving patients with Diabetes Mellitus (DM). Recent trials on patients with Heart Failure (HF) have also shown that SGLT2i reduce mortality, morbidity and hospitalisations, even in patients without DM. This improvement is seen early after starting treatment and one of the leading theories on the mechanism is by a reduction in sudden cardiac arrhythmic death. Cardiac Arrhythmias are strongly influenced by cardiac autonomic function and this study will evaluate related parameters such as heart rate variability and heart rate turbulence, before and after SGLT2i therapy in diabetic and HF patients using heart monitors known as Holters. This may provide us with insight into how SGLT2i reduce mortality, their potential impact on cardiac rhythm and help direct future therapy.
Circulating biomarkers (hsTnT, NT-proBNP, hsCRP, TNF-a, IL6, VEGF-A, microRNAs) are linked to cardiovascular disease. The impact of SGLT2i on these markers could shed some light on the reasons for their clinical benefits.
There is an established association between DM and sarcopenic obesity. It has been suggested that SGLT2i lead to weight loss due to the glycosuric effect, and have a beneficial negative impact on adiposity via adipocyte dysfunction. An analysis of the impact of SGLT2i on body composition may provide us with an explanation for their benefit on overall cardiac health.REC name
East of England - Cambridge South Research Ethics Committee
REC reference
24/EE/0121
Date of REC Opinion
11 Jun 2024
REC opinion
Further Information Favourable Opinion