Type 2 diabetes Nutritional, Metabolic, Endocrine
Conditions
Interventions
Participants will have blood glucose monitored for 2 weeks before randomisation.
Then participants will be randomly allocated to receive:
Diet A: Low carbohydrate, low-energy food-based diet 800-100
(<26%% total energy from carbohydrate, absolute carbohydrate content approx. 60-65g/day).
Diet B: Low carbohydrate “ad libitum” (eucaloric) diet (no energy restriction, aiming for no significant weig
estimated 2000-2500kcal/day
<26% total energy from carbohydrate – absolute carbohydrate content approx. 125g/day).
The dietary intervention lasts for 4 weeks.
Sponsors
University of Oxford
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Participants willing and able to give informed consent. 2. Adult male or female, aged 18-70 years old. 3. Diagnosed with current type 2 diabetes (i.e. not in remission). 4. BMI of > = 27kg/m². 5. Has a smartphone with internet access and compatible with continuous glucose monitoring (CGM) technology, and participant is willing and able to use this. 6. Is willing and able to change their diet for the study period. 7. Willing to pause one or more usual medications if required for duration of study.
Exclusion criteria
Exclusion criteria: 1. Pregnant, breastfeeding, or planning to become pregnant during the course of the study. 2. Recent weight loss (> 2kg in last 4 weeks; self-reported). 3. People who are already following a specific restricted diet. 4. Are currently taking more than two prescribed medications for diabetes glycaemic control. 5. People with HbA1c > = 87 mmol/mol. 6. Are currently using insulin therapy, SGLT2 inhibitors (Gliflozins – eg empaglifozin, dapagliflozin, canagliflozin), or GLP-1 agonists (e.g. exenatide, lixisenatide, liraglutide, dulaglutide and semaglutide). 7. Previous or current eating disorder (or any other psychological condition) that may affect the participant’s ability to adhere to study intervention/experimental diets. 8. Recent myocardial infarction or stroke ( 5 mmol/l.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Glycaemic control measured using continuous glucose monitoring. Participants will wear the monitor for the entire 6-week duration of the study. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Glycaemic control measured using continuous glucose monitoring. Participants will wear the monitor for the entire 6-week duration of the study 2. Cardiometabolic risk - assessed via changes in blood lipids (Total-, HDL-, LDL- cholesterol and triglycerides), liver function (bilirubin, ALT and ALP) and blood pressure at baseline, at the end of the 2-week habitual phase and at the end of the 4-week intervention phase 3. Subjective measures of appetite - assessed using VAS scores for hunger fullness, desire to eat and planned consumption using Ecological Momentary Assessment once per week during the habitual and intervention phase 4. Body composition - assessed as body mass, impedance, waist and hip circumference at baseline, at the end of the 2-week habitual phase and at the end of the 4-week intervention phase | — |
Countries
England, United Kingdom
Contacts
Public ContactSam West
Outcome results
None listed