None listed
Conditions
Brief summary
Diabetes is one of the most common chronic conditions in New Zealanders. Type 2 Diabetes is the most common type of diabetes and is a cause of considerable ill health and premature death. Weight loss can improve blood sugar control and heart health which can reduce complications of diabetes. One problem is helping people keep to dietary changes that help long term weight loss. This means that health professionals need to investigate new diets and make sure that they are safe for people with diabetes. One new diet is the “intermittent fasting diet”. This diet has people eat very little on two days a week, and a normal healthy diet on the other five days a week. Initial research shows that this type of diet may be easier to stick to and result in better insulin sensitivity than traditional diets. There has been no research on whether this type of diet is safe for people who have type 2 diabetes and are treated using insulin. This feasibility study will help tell us if this is an effective way to lose weight, and a safe diet for people with diabetes on insulin. Forty people who attend the Diabetes Centre at Waitemata DHB will be recruited for a 12 week intervention study. They will be randomly put in to two groups. One group will follow a healthy eating plus intermittent fasting diet three “meals”for two days a week, and five days a week will be a low fat, high fibre carbohydrate healthy eating plan with participants usual portion sizes. The other group will follow a healthy eating plus portion control eating plan based on Diabetes NZ dietary recommendations. Dietary information, medication dose adjustment and blood glucose patterns will be taught at a monthly group education and support programme. The hypothesis is that following an intermittent fasting diet for weight reduction is a safe and effective weight reduction strategy when compared to current standard practice of healthy eating portion controlled dietary advice.If it is safe and effective diet for people with diabetes on insulin then it could have direct impact on improving quality of life and reducing healthcare burdens.
Interventions
12 week group based education. Three group education sessions (1 hour) every 4 weeks, followed by final one-to-one interview at week 12. Group sessions will cover motivation, hypo / hyperglycaemia management, blood sugar pattern management, low fat / high fibre food choices, and dietary choices for fasting days. There will be maximum of 10 participants per group (not including support person) - 2 x 10 participant groups will be run. The final one-to-one interview (45 minutes) at week 12 wi
12 week group based education. Three group education sessions (1 hour) every 4 weeks, followed by final one-to-one interview at week 12. Group sessions will cover motivation, hypo / hyperglycaemia management, blood sugar pattern management, low fat / high fibre food choices, and dietary choices for fasting days. There will be maximum of 10 participants per group (not including support person) - 2 x 10 participant groups will be run. The final one-to-one interview (45 minutes) at week 12 will include final data collection point (anthropometric and biochemical measurements) and future requirements for weight reduction interventions. Intervention group - Healthy eating + Intermittent fasting diet. 2 days out of 7 consumption limited to 500-600kcal daily; 5 days of out 7 consumption advised low fat, regular high fibre carbohydrate usual portion sizes. Participants will complete a daily blood glucose diary which includes a weekly fasting-adherence diary. Three two day food diaries will be completed during the study. Phone call interviews will be used fortnightly, between group sessions to check blood sugar management and reminders to complete food diaries.
Sponsors
Diabetes Service, North Shore Hospital
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
35 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
Type 2 diabetes treated using insulin (+/- oral hypoglycaemic agents). Body Mass index 30-39 kg/m2 (inclusive). Aged 35-65 years (inclusive), HbA1c 55-90 mmol/mol. Screened for hypoglycaemic awareness and frequency. Stable and well controlled other medical conditions. Willing to undertake a 12 week intervention for weight reduction.
Exclusion criteria
Hypoglycaemic unawareness / admission to hospital in previous 12 months with diabetic ketoacidosis, hyperglycaemia, hypoglycaemia. Renal disease / chronic kidney disease. Unstable heart disease. Diagnosed eating disorder in the past. Medical condition where sudden weight loss may impact on either condition or treatment. Unstable or uncontrolled medical conditions. Pregnant or breastfeeding women. Requires translation of written or spoken English.
Outcome results
None listed