Skip to content

Effects of a low carbohydrate diet on heart failure symptoms and quality of life in patients with diabetic cardiomyopathy.

Effects of a low carbohydrate diet on heart failure symptoms and quality of life in patients with diabetic cardiomyopathy.

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12620001278921
Enrollment
80
Registered
2020-11-26
Start date
2021-01-11
Completion date
2021-04-01
Last updated
2021-07-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Diabetes may contribute to the development of a certain form of heart disease, also known as diabetic cardiomyopathy. Diabetic cardiomyopathy occurs in the absence of heart disease or high blood pressure. It encompasses a variety of processes impacting on the pumping action of the heart muscle and shortening life expectancy. Symptoms include shortness of breath, decreased exercise tolerance and thirst which are associated with a poor quality of life. There are currently limited management strategies available for patients with diabetic cardiomyopathy. There is a lack of evidence to support if patients require a special diet to improve their symptoms and quality of life. Traditional dietary recommendations provide limited symptom relief for this patient group. However, diets that are low in carbohydrate have been shown to improve blood glucose levels and reduce the risk for heart disease. Hence, a low carbohydrate diet may reduce the long-term complications of diabetes. With this in mind, the aim of this research is (a) to explore if a diet low in carbohydrates has an impact on symptoms of heart failure such as thirst and quality of life in patients suffering from diabetic cardiomyopathy and (b) to identify what factors influence a participant’s ability to continue this dietary change.

Interventions

The intervention group (low carbohydrate diet): For the purpose of this study, participants will be coached by the student researcher who will be guided by a qualified dietitian, to follow a LC diet as defined by an intake of less than 130g of carbohydrate per day (Hite et al., 2019). To achieve a CHO ingestion of less than 130g per day, the participants will be instructed to enjoy a variety of above ground and green, leafy vegetables. Small amounts of fruit, starchy vegetables such as potatoes,

The intervention group (low carbohydrate diet): For the purpose of this study, participants will be coached by the student researcher who will be guided by a qualified dietitian, to follow a LC diet as defined by an intake of less than 130g of carbohydrate per day (Hite et al., 2019). To achieve a CHO ingestion of less than 130g per day, the participants will be instructed to enjoy a variety of above ground and green, leafy vegetables. Small amounts of fruit, starchy vegetables such as potatoes, sweet potatoes, parsnip, peas and corn, nuts/seeds and legumes are permitted. Participants are encouraged to eat freely from animal and plant proteins such as chicken, fish, unsweetened dairy products and tofu. Participants will be coached to avoid high CHO foods such as bread, rice, pasta, sweetened beverages and alcohol. Food lists using a “traffic light system” will be provided to the participants as a reference and to enhance compliance with the diet. These lists categorise foods and drinks into: Always/every day (green list), sometimes (orange list) and avoid (red list). Minimum Dietary protein intake level will be set to 1.2 – 1.7 g/kg of ideal body weight, in keeping with both the Clinical Guidelines for Therapeutic Carbohydrate Restriction (Hite et al., 2019) and the Australian Dietary Guidelines (National Health and Medical Research Council, 2013). Dietary fat intake will not be restricted. Dietary sodium intake will be limited to <2g/day in accordance with The National Heart Foundation of Australia and Cardiac Society of Australia and New Zealand guidelines for the prevention, detection, and management of HF in Australia (Atherton et al., 2018). A 16-week time frame for the intervention has been proposed. In the first month the participants will be introduced to the low carbohydrate diet. Participants will be invited to attend a 60-minute group counselling session, once per week in the first 4 weeks and fortnightly individual 60-minute sessions for the following 12 weeks. Sessions will be held face to face, via phone call or via video conferencing if the participants prefer. Participants will be requested to change their diet gradually over the initial four weeks and should ideally have adjusted all their meals to the low carbohydrate recommendations when attending the fourth session at the end of the first month. The counselling sessions will focus on discussion of the underlying mechanisms that drive type 2 diabetes and heart failure, instructions on dietary carbohydrate restriction, food selection and meal preparation, interpretation of food labels, recognition of potential side effects, establishing mindful eating techniques, difficulties in adhering to the diet and support for health behaviour change. Dietary counselling will be adapted to the personal, as well as the religious and cultural food preferences of the participants. All study participants will be offered the opportunity to invite a member of their family/household to attend the education sessions if they chose. Participants will be asked to complete three 24-hour dietary recalls using the validated INTAKE-24 AUS computerised dietary recall system (Simpson et al., 2017). The recall diary will specifically monitor the food intake of two weekdays and one weekend day at baseline, week six and at the end of the intervention (week 16). This way, the extent of the patient’s dietary changes will become apparent. INTAKE-24 AUS is based on the original web-based system INTAKE-24 UK, developed by researchers at the Human Nutrition Research Centre at Newcastle University (Simpson et al., 2017). INTAKE-24 AUS provides a reliable, affordable and user friendly 24-hour dietary recall system (Simpson et al., 2017). Based on the multiple-pass 24-hour recall (Raper et al., 2004), INTAKE-24 AUS includes an extensive variety of foods commonly eaten in Australia, linked to nutrient composition codes (Foster et al., 2019). As the user is prompted through the recall process, the inclusion of food images enables easy portion size estimation by participants without the need for weighing of food (Simpson et al., 2017). The advantage of this web-based recall system compared to other methods is that it enables the participant to complete the recall where and when it is convenient for them. In addition to this, participants will be invited to complete a mini food frequency questionnaire (FFQ). The food questionnaire is a self-administered assessment tool to estimate food frequency intake over a specific period of time. Dietary counselling will be adapted to the personal, as well as the religious and cultural food preferences of the participants.

Sponsors

Professor Andrea Driscoll
Lead SponsorIndividual

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

• Patients over the age of 18 • Diagnosis of HF based on echocardiography and/or Boston criteria • Patients diagnosed with T2DM (HbA1C greater than or equal to 6.5) • Patients not diagnosed with T2DM but diagnosed with IR as defined by a triglyceride and glucose index (TyG)* value of >4.49 • Patients who speak and understand sufficient English to consent. • Access to an electronic device with internet connection *Participants who are not diagnosed with T2DM but would like to enter the study may undergo screening for IR. The TyG is a simple, cost effective and reliable tool to identify IR in an individual. It is established through the equation: TyG = Ln [fasting triglyceride (mg/dl) x fasting glucose (mg/dl)] / 2 The cut off for IR is placed at the TyG index of 4.49 with a sensitivity of 82.6% and specificity of 82,1% (AUC = 0.889, 95% CI: 0.854-0.924). The serum triglyceride levels, and glucose levels needed to establish IR will be ordered as part of the usual care for patients in the HF clinic.

Exclusion criteria

• Patients with T1DM may not be appropriate for the LC diet intervention due to their strict insulin requirements • Patients with T2DM who require insulin • Patients taking SGLT-2 inhibitors. There is a small risk of euglycaemic ketoacidosis in patients who take SGLT-2 inhibitors and simultaneously follow a low carbohydrate diet. • Patients who are unable to give informed consent • Patients suffering from cardiac cachexia as defined by an unintentional non-oedematous weight loss of >5% over at least six months. Cardiac cachexia is a sign of advanced heart failure. It is defined by muscle wasting and systemic inflammation. Patients with cardiac cachexia have strict energy and nutritional requirements and are therefore not suitable for this study.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 10, 2026