NCT04916314: RESULT

REmote SUpport for Low-Carbohydrate Treatment of Type 2 Diabetes

Completed NA Results posted Last updated 5 January 2026

What this trial tests

NA trial testing Low Carbohydrate diet in Type 2 Diabetes Mellitus in Obese in 115 participants. Completed in 1 October 2023.

Timeline

1 July 2021

Primary endpoint
1 October 2023

1 October 2023

Quick facts

Lead sponsor	University of Oxford
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	115
Start date	1 July 2021
Primary completion	1 October 2023
Estimated completion	1 October 2023
Sites	1 location across United Kingdom

Drugs / interventions tested

• Low Carbohydrate diet

Conditions studied

• Type 2 Diabetes Mellitus in Obese — all drugs for Type 2 Diabetes Mellitus in Obese →

Sponsor

University of Oxford

Who can join

40 and older, any sex, with Type 2 Diabetes Mellitus in Obese. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Change From Baseline in Participants' HbA1c Primary · Baseline to 3 months

Change in participants' HbA1c from baseline to 3 months

Group	Value	95% CI
Low Carbohydrate Diet	-2.3	± 7.9
Standard NHS Type 2 Diabetes Care	-2.4	± 8.5

Change From Baseline in Participants' HbA1c Primary · Baseline to 12 months

Change in participants' HbA1c from baseline to 12 months

Group	Value	95% CI
Low Carbohydrate Diet	0.4	± 11.9
Standard NHS Type 2 Diabetes Care	-1	± 15.8

Diabetes Remission at 12 Months Secondary · 1 year

Number of participants meeting consensus definition for remission from type 2 diabetes at 1 year

Group	Value	95% CI
Low Carbohydrate Diet	4
Standard NHS Type 2 Diabetes Care	1

Weight Change From Baseline Secondary · 3 months,1 year

Change in participants' weight from baseline to 3 and 12 months

Weight change from baseline at 3 months

Group	Value	95% CI
Low Carbohydrate Diet	-3.6	± 3.6
Standard NHS Type 2 Diabetes Care	-0.7	± 5.9

Weight change from baseline at 12 months

Group	Value	95% CI
Low Carbohydrate Diet	-2.4	± 5.3
Standard NHS Type 2 Diabetes Care	-2.7	± 5.9

Change in Systolic Blood Pressure, From Baseline Secondary · 3 months, 1 year

Change in participants' systolic blood pressure from baseline

Systolic BP change from baseline to 3 months

Group	Value	95% CI
Low Carbohydrate Diet	-2.1	± 12.3
Standard NHS Type 2 Diabetes Care	-2.9	± 13

Systolic BP change from baseline to 12 months

Group	Value	95% CI
Low Carbohydrate Diet	-1.6	± 14.2
Standard NHS Type 2 Diabetes Care	-0.9	± 15.2

Change in Diastolic Blood Pressure, From Baseline Secondary · 3 months, 1 year

Change in participants' diastolic blood pressure from baseline to 3 and 12 months

Diastolic BP change from baseline to 3 months

Group	Value	95% CI
Low Carbohydrate Diet	-2.1	± 9.1
Standard NHS Type 2 Diabetes Care	-3.2	± 8

Diastolic BP change from baseline to 12 months

Group	Value	95% CI
Low Carbohydrate Diet	-0.21	± 0.61
Standard NHS Type 2 Diabetes Care	-0.35	± 0.98

Change in LDL Cholesterol From Baseline Secondary · 3 months, 1 year

Change in participants' LDL cholesterol from baseline to 3 and 12 months

LDL cholesterol change from baseline to 3 months

Group	Value	95% CI
Low Carbohydrate Diet	-0.04	± 0.52
Standard NHS Type 2 Diabetes Care	-0.10	± 0.49

LDL cholesterol change from baseline to 12 months

Group	Value	95% CI
Low Carbohydrate Diet	-0.22	± 0.62
Standard NHS Type 2 Diabetes Care	0.04	± 0.15

Change in Total Cholesterol:HDL Ratio From Baseline Secondary · 3 months, 1 year

Change in participants' total cholesterol:HDL ratio from baseline to 3 and 12 months

Total cholesterol:HDL ratio change from baseline to 3 months

Group	Value	95% CI
Low Carbohydrate Diet	-0.11	± 0.71
Standard NHS Type 2 Diabetes Care	-0.36	± 0.87

Total cholesterol:HDL ratio change from baseline to 12 months

Group	Value	95% CI
Low Carbohydrate Diet	-0.35	± 0.67
Standard NHS Type 2 Diabetes Care	-0.55	± 1.09

Change in HDL Cholesterol, From Baseline Secondary · 3 months, 1 year

Change in participants' HDL cholesterol from baseline to 3 and 12 months

HDL cholesterol change from baseline to 3 months

Group	Value	95% CI
Low Carbohydrate Diet	0.03	± 0.17
Standard NHS Type 2 Diabetes Care	0.04	± 0.15

HDL cholesterol change from baseline to 12 months

Group	Value	95% CI
Low Carbohydrate Diet	0.07	± 0.39
Standard NHS Type 2 Diabetes Care	0.04	± 0.15

Change in Triglycerides, From Baseline Secondary · 3 months, 1 year

Change in participants' triglycerides from baseline to 3 and 12 months

Triglycerides change from baseline to 3 months

Group	Value	95% CI
Low Carbohydrate Diet	-0.07	± 1.03
Standard NHS Type 2 Diabetes Care	-0.29	± 1.28

Triglycerides change from baseline to 12 months

Group	Value	95% CI
Low Carbohydrate Diet	-0.25	± 0.86
Standard NHS Type 2 Diabetes Care	-0.19	± 1.29

Change in ALT From Baseline Secondary · 3 months, 1 year

Change in participants' ALT from baseline to 3 and 12 months

Change in ALT from baseline to 3 months

Group	Value	95% CI
Low Carbohydrate Diet	-3.3	± 13
Standard NHS Type 2 Diabetes Care	-2.4	± 10.9

Change in ALT from baseline to 12 months

Group	Value	95% CI
Low Carbohydrate Diet	-2.1	± 15.4
Standard NHS Type 2 Diabetes Care	-4.1	± 16.6

Change in Diabetes Related Quality of Life and Distresses - Problem Areas In Diabetes (PAID) Score From Baseline Secondary · 3 months, 1 year

Change in participants' PAID score from baseline to 3 and 12 months. (Minimum- maximum score; 0-100). Lower score indicating lower diabetes burden.

Change in PAID score from baseline to 3 months

Group	Value	95% CI
Low Carbohydrate Diet	-12.3	± 18.1
Standard NHS Type 2 Diabetes Care	-11.4	± 16.2

Change in PAID score from baseline to 12 months

Group	Value	95% CI
Low Carbohydrate Diet	-14.8	± 17.2
Standard NHS Type 2 Diabetes Care	-10	± 16.5

Adverse events — posted to ClinicalTrials.gov

Time frame: 1 year. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Low Carbohydrate Diet

Serious: 0/55 (0%)

Deaths: 0/55

Standard NHS Type 2 Diabetes Care

Serious: 0/60 (0%)

Deaths: 0/60

Other adverse events (1 terms — click to expand)

Reaction	System	Low Carbohydrate Diet	Standard NHS Type 2 Diabet…
Unplanned hospital admission	Investigations	—	—

Data from ClinicalTrials.gov NCT04916314 adverse events section.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. A randomised controlled trial of a low-carbohydrate digitally-supported weight loss programme for type 2 diabetes.
   Morris E, Scragg J, Stevens R, Albury C, et al · · 2025 · PMID 41331050 · DOI 10.1038/s41746-025-02116-w