A low-carbohydrate, low-energy dietary intervention for patients with type 2 diabetes in primary care: a feasibility study

niversity of Oxford0 sites33 target enrollmentApril 4, 2018

Overview

2019 Protocol article in https://www.ncbi.nlm.nih.gov/pubmed/30659044 protocol (added 24/02/2020) 2020 Results article in https://pubmed.ncbi.nlm.nih.gov/31709697/ results (added 06/10/2020)

Registry

who.int

Start Date

April 4, 2018

End Date

September 30, 2019

Last Updated

4 years ago

Study Type

Interventional

Sex

All

Sponsor

•1\. Participant is willing and able to give informed consent for participation in the study
•2\. Male or female, aged 18 years or above
•3\. BMI of \=30kg/m2
•4\. Diagnosed with type 2 diabetes
•5\. Patients must have undergone diabetic retinopathy screening within the last 12 months

•1\. History of, or features suspicious of, an eating disorder
•2\. Pregnant, breastfeeding, currently undergoing fertility treatment, or planning to become pregnant during the course of the study
•3\. Recent MI or CVA (\<3 months)
•4\. Uncontrolled ischaemic heart disease, critical ischaemia, uncontrolled hypertension, uncontrolled cardiac arrhythmia (eg inadequate rate control in AF, inadequate episode control paroxysmal AF), cardiac conduction abnormality (eg long QT syndrome)
•5\. Cardiac failure (Grade II New York Heart Association, and more severe)
•6\. Renal failure (CKD Stage 4 or 5\)
•7\. Active treatment for cancer (other than skin cancer treated with curative intent by local treatment only)
•8\. Intercurrent serious infection at time of recruitment
•9\. Diagnosed with a significant psychiatric disorder or substance abuse
•10\. Serious neurological disorder, including epilepsy