Manchester Intermittent and Daily diet Diabetes App Study
- Conditions
- Specialty: Diabetes, Primary sub-specialty: Type 2UKCRC code/ Disease: Metabolic and Endocrine/ Diabetes mellitusNutritional, Metabolic, EndocrineDiabetes
- Registration Number
- ISRCTN15394285
- Lead Sponsor
- niversity Hospital of South Manchester NHS Foundation Trust
- Brief Summary
2021 Results article in https://pubmed.ncbi.nlm.nih.gov/33739297/ (added 22/03/2021)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Ongoing
- Sex
- All
- Target Recruitment
- 79
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 <50kg/m2 or >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
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method