Status:
COMPLETED
REmote SUpport for Low-Carbohydrate Treatment of Type 2 Diabetes
Lead Sponsor:
University of Oxford
Conditions:
Type 2 Diabetes Mellitus in Obese
Eligibility:
All Genders
40+ years
Phase:
NA
Brief Summary
Excess adiposity is a key causal factor in developing type 2 diabetes and weight loss improves glycaemia and can put diabetes in to remission. There is evidence that low carbohydrate diets also reduce...
Detailed Description
This is an individually randomised controlled trial. Participants, recruited via GP practices, will be randomised 1:1 with simple randomisation and no stratification to either the intervention group o...
Eligibility Criteria
Inclusion
- Participant is willing and able to give informed consent for participation in the study.
- Male or Female, aged 40 years or above.
- Diagnosed with current type 2 diabetes (i.e. not in remission) in the last 6 years
- BMI of ≥27kg/m2 (≥30kg/m2 if ethnicity recorded as white)
- Has a smartphone or computer with internet access (and the correct operating system requirements to use the intervention programme)
- Are able to complete the eligibility and baseline assessments online
- Would like to make changes to their diet or lifestyle to improve their diabetes control, lose weight, or improve their general health
Exclusion
- Unable to understand the study materials and interventions
- Currently following a weight loss programme (defined as a structured, prescribed and monitored programme and not a self-directed weight loss attempt)
- Pregnant, breastfeeding, or planning to become pregnant during the course of the study
- History of bariatric surgery, including gastric banding
- Currently using insulin therapy
- Proliferative diabetic retinopathy, or maculopathy.
- Recent myocardial infarction or stroke (\<3 months)
- Renal failure (chronic kidney disease stage 4 or 5)
- Current active treatment for cancer (other than skin cancer treated with curative intent by local treatment only)
- Their doctor does not feel they are appropriate to participate for another reason (e.g. active eating disorder diagnosis, significant psychological disturbance)
Key Trial Info
Start Date :
July 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2023
Estimated Enrollment :
115 Patients enrolled
Trial Details
Trial ID
NCT04916314
Start Date
July 1 2021
End Date
October 1 2023
Last Update
January 5 2026
Active Locations (1)
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1
University of Oxford
Warwick, Select A Region, United Kingdom, CV34 4NH