Specialty: Diabetes, Primary sub-specialty: Type 2
Conditions
Interventions
Participants are randomly allocated to one of two low calorie diets. Participants in group one complete the standard daily low calorie diet of 800 calories/day for eight weeks. Participants in group 2
Sponsors
University Hospital of South Manchester NHS Foundation Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients aged 18–75 years 2. Patients with diagnosis of T2DM for less than 8 years , based on 2 recorded diagnostic-level tests, HbA1c and/or blood glucose or OGTT 3. HbA1c = 48 mmol/mol within last 12 months 4. Body Mass Index (BMI) >27 kg/m2 and 25 kg/m2 and <50kg/m2 in high-risk minority ethnic groups (specifically South Asian, Black African and African Caribbean people) 5. Patients should have access and able to use a smartphone or tablet running iOS or Android to be able to use the Oviva app OR access and ability to use a telephone 6. Participants must be willing to give written informed consent and be able to adhere to the study schedules and procedures 7. Patients should be willing to follow the VLED using Optifast drinks 8. Female participants of childbearing age must agree to maintain highly effective contraception during their participation in the study and must have negative pregnancy test at screening and each study visit where there is a possibility they could be pregnant
Exclusion criteria
Exclusion criteria: 1. Patients with recent routine HbA1c > = 108 mmol/mol (last 3 months) or at screening 2. Patients with non-stable retinopathy, or grade R2 or later, or had no retinopathy screen within 12 months 3. Patients presenting with severe systemic or organ disease, or active cancer 4. Patients who experienced unintentional weight loss of > 5 kg within the last 6 months 5. Patients who lack capacity or are unable to read or understand written or verbal instructions in English or those diagnosed with learning difficulties 6. Patients intend to become pregnant during the study or pregnancy confirmed by pregnancy test during the trial. 7. Patients with a history of self- harm and previous diagnosis of borderline personality disorder or bipolar disorder history. Diagnosis of substance abuse or harmful alcohol use or dependency, OR a positive AUDIT Alcohol Screen with an AUDIT total score of above 15 (high risk or harmful level). 8. Patients with score of 35 or below as assessed with a Weight Efficacy Lifestyle Questionnaire Short-Form (WEL-SF) 9. Patients who are diagnosed with eating disorder, OR a score of score of 27 or more (severe binge-eating using Binge Eating Scale (BES) 10. Patients with moderate to severe depression assessed with the Patient Health Questionnaire-9 (PHQ-9) of 16 or more. Patients with severe anxiety assessed with a general anxiety disorder (GAD-7) scale 16 or more. 11. Patients who are on lithium carbonate or other psychotropic medications 12. Patients who are currently on treatment with Orlistat 13. Patients who have previously had bariatric surgery for weight loss including gastric bypass and sleeve gastrectomy 14. Patients who are on chronic use of steroids (more than 20mg daily of prednisolone or its equivalent) . 15. Patients with known hypersensitivity to any of the ingredients of Optifast® diet i.e lactose intolerance 15. Other medical conditions which in the opinion of the treating physician will put the patient at risk of deterioration in their conditions or use of VLED is contraindicated such as: 15.1. Recent (within the last 3 months) cardiovascular diseases (e.g. acute myocardial infarction, unstable angina, stroke or transient ischemic attack, active thrombophlebitis 15.2. Gastrointestinal conditions such as liver cirrhosis/ failure, active hepatitis, gall bladder disease, acute pancreatitis, active peptic ulcer 15.3. Metabolic disorders such as porphyria 15.4. Advance renal diseases (eGFR < 30 mL/min./sq.m) 15.5. Major bone fractures (e.g. pelvis or hip) in the past 6 months 16. Patients who are currently in a diabetes therapy trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Enrolment rate is measured using the data collected on numbers of patients at end of recruitment window (6 months) 2. Proportion of participants who lose and maintain 15% weight loss is measured using ITT analysis (intention to treat (ITT) analysis) at 12 months 3. Proportion of participants who achieve good blood sugar levels are measured using an intention to treat analysis at 12 months | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Quality of life is measured using the EQ-5D-3L and Audit of Diabetes-Dependent Quality of Life questionnaires at weeks 27 and 52 2. Body composition is measured using the Tanita 180 at weeks 8,12, 27 and 52 weeks and fasting blood glucose levels weeks 8,12,27,52 3. Cardiovascular risk markers measured using blood pressure, weight, waist circumference at baseline weeks 8,12, 27, 52 and lipid profile at baseline, weeks 27 and 52 4. Reduction in diabetes medicine is measured using data collected on treatments and current treatments as per the study protocol at the end of the study 5. Feasibility is measured using a qualitative interview at weeks 8, weeks 27 and 52 | — |
Countries
England, United Kingdom
Outcome results
None listed