Effects of time restricted eating compared to diet modification in people with type 2 diabetes
- Conditions
- Type 2 diabetesOverweight/ObesityMetabolic and Endocrine - DiabetesDiet and Nutrition - Obesity
- Registration Number
- ACTRN12620000453987
- Lead Sponsor
- Dr Evelyn Parr
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 52
• Aged 35 to 65 years old
• Diagnosed (by a GP/endocrinologist) with type 2 diabetes mellitus (T2D), with an HbA1c between 6.5% - 10%, either with diet-controlled or taking up to two oral hypoglycaemic agents (excluding sulphonylureas)
• Body mass index (BMI) between 25 - 45 kg/m2 (but total mass not >200 kg due to DXA measures)
• Currently consuming energy (i.e. dietary intake) over a period of 12 h or more, habitually (i.e. self-reported on 5/7 days per week)
• Does not have a smart phone or cannot operate the camera function on a smart phone;
• Taking more than 2 oral hypoglycaemic agents (OHAs), taking sulphonylrueas, or other glucose lowering medications (i.e. GLP-1 angonists, or insulin), or unstable use of OHA (i.e. not taking them for at least a 3 month period).
• Currently following a strict diet (i.e. vegan, coeliac/gluten free, ketogenic);
• Currently seeing or within 1 month of seeing a dietitian;
• Participate in regular fasting (defined as fasting for greater than or equal to 16 h/day or having completed twelve 24-h fasts within the past year);
• Participating in shift work (i.e. >3 h between 10 pm and 5 am for 1 day per week (>50 days per year))
• Not weight stable (>5 kg change over last 3 months);
• On prescribed medications required to be taken with food in the early morning or late evening or taking other prescribed medications for <3 months;
• Current smoker (tobacco, nicotine or marijuana) or within 3 months of quitting;
• Women who are pregnant, breastfeeding (within 24 wk);
• History of psychotic disorder, current diagnosis of other major psychiatric illness (e.g. mood disorder, eating disorder, substance use disorder; does not include depression)
• Psychopharmacological treatment that has not been stable for more than 3 months;
• Medications known to promote weight gain, weight loss or interact with glucose metabolism (i.e. corticosteroids);
• Diagnosed gastrointestinal conditions, surgery (i.e. bariatric) or impaired nutrient absorption.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method As a clinically-relevant measure of improved glycemic control, HbA1c (%) will be measured from whole blood in both groups. [HbA1c (%) will be measured every two months (baseline, 2 months, 4 months and 6 months) with the primary comparison being the change measured between baseline and 6 months.]
- Secondary Outcome Measures
Name Time Method