N/A
N=115
REmote SUpport for Low-Carbohydrate Treatment of Type 2 Diabetes
Type 2 Diabetes Mellitus in Obese
Bottom Line
View on ClinicalTrials.gov: NCT04916314 ↗Enrolled (actual)
115
Serious AEs
0.0%
Results posted
Jan 2026
Primary outcome: Primary: Change From Baseline in Participants' HbA1c — -2.3; -2.4 mmol/mol — p=0.8
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Low Carbohydrate diet (Behavioral)
- Age
- Adult, Older Adult · 40+ yrs
- Sex
- All
- Sponsor
- University of Oxford
- Primary completion
- Oct 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Participants' HbA1c |
0.4; -1 | 0.8 |
| PRIMARY Change From Baseline in Participants' HbA1c |
0.4; -1 | 0.8 |
| SECONDARY Diabetes Remission at 12 Months |
4; 1 | — |
| SECONDARY Weight Change From Baseline |
-3.6; -0.7; -2.4; -2.7 | — |
| SECONDARY Change in Systolic Blood Pressure, From Baseline |
-2.1; -2.9; -1.6; -0.9 | — |
| SECONDARY Change in Diastolic Blood Pressure, From Baseline |
-2.1; -3.2; -0.21; -0.35 | — |
| SECONDARY Change in LDL Cholesterol From Baseline |
-0.04; -0.10; -0.22; 0.04 | — |
| SECONDARY Change in Total Cholesterol:HDL Ratio From Baseline |
-0.11; -0.36; -0.35; -0.55 | — |
| SECONDARY Change in HDL Cholesterol, From Baseline |
0.03; 0.04; 0.07; 0.04 | — |
| SECONDARY Change in Triglycerides, From Baseline |
-0.07; -0.29; -0.25; -0.19 | — |
| SECONDARY Change in ALT From Baseline |
-3.3; -2.4; -2.1; -4.1 | — |
| SECONDARY Change in Diabetes Related Quality of Life and Distresses - Problem Areas In Diabetes (PAID) Score From Baseline |
-12.3; -11.4; -14.8; -10 | — |
| SECONDARY Change in Participants' EQ5D Score From Baseline |
0.059; 0.0004; 0.041; 0.001; 5.2; 4.0 | — |
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 glycaemia. The aim of this trial is to test a behavioural support programme delivered remotely to reduce energy intake and carbohydrate intake in particular to improve glycaemic control in people recently diagnosed with type 2 diabetes. We will recruit participants from general practice diabetes registers who were diagnosed within the past six years and who want to and are able to follow an app-based behavioural support programme to change their diet and have a BMI of at least 27kg/m2 (≥30kg/m2 if of white European ethnicity). They will be individually randomised 1:1 using simple randomisation to either intervention or a no-intervention control. Blinding of participants or their clinicians is impossible. The intervention comprises a 12-week behavioural support programme delivered by app or web, which provides group-based peer support, recipes for food providing low energy meals that are low in carbohydrate. The programme is delivered by a commercial company who run NHS commissioned programmes in several areas of the UK. Clinicians will adjust medication for hypertension and diabetes as needed. The co-primary outcomes are change in participants' HbA1c from baseline to 3 months and baseline to 1 year, with p-value adjustment to reflect multiple testing. The secondary outcomes are remission from diabetes, weight change, change in cardiovascular risk factors, and change in quality of life at 3 months and 1 year. The trial will assess whether this app-based programme improves outcomes for people with type 2 diabetes relative to usual care.
Eligibility Criteria
Inclusion Criteria
- 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 Criteria
- 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)
Data sourced from ClinicalTrials.gov (NCT04916314). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.