Low carbohydrate diet for diabetic cardiomyopathy: Protocol for a randomised controlled trial

Abstract

Background: Insulin resistance (IR) and type 2 diabetes (T2DM) promote myocardial dysfunction in the absence of traditional cardiovascular risk factors such as hypertension or coronary heart disease. Termed diabetic cardiomyopathy (DMCM), this type of cardiomyopathy often evolves to heart failure (HF), therefore worsening outcomes for people living with T2DM. Low-fat diets (LF) have been recommended for patients with cardiovascular disease but have provided limited symptom relief.Aim: The aim of this research is to examine the effect of a low-carbohydrate (LC) diet compared with usual care (UC) in patients with DMCM. This study hypothesises that the LC diet will improve symptoms of HF and quality of life (QoL) in patients with DMCM.Setting: For this 16-week randomised controlled trial 80 adult patients ( 18 years of age) with T2DM (HbA1c ≥ 6.5) or IR (triglyceride glucose index value [TyG] 4.49) and HF from an outpatient HF clinic in Victoria, Australia were recruited.Methods: Participants will be randomised to a LC or a LF diet (UC) group. The primary outcome is a composite endpoint of changes in New York Heart Association (NYHA) class, hospital admissions, thirst distress and QoL. The secondary endpoint is a 2% change in HbA1c from baseline. Outcomes will be assessed at baseline, week 6 and week 16.Results: This article describes a protocol for a radomised controlled trial (RCT). The results of this trial will be published at the completion of the study.Conclusion: The results from this trial will provide an insight into the future dietary management of DMCM for both patients and healthcare practitioners.