TWO BIRDS - Intensive lifestyle and medication to help improve diabetes and fatty liver disease through weight loss

The study will be overseen by the clinician-investigator (RB) who will review all patients for suitability, consenting and medical review as per our protocol. The intervention arm will receive industry-funded Optifast® program: 5-months of complete VLCD (820 KCal/day,) using Optifast® Phase 1: 3-4 meal replacements per day (months 1-3); Phase 2: 2 meal replacements plus one self-prepared healthy meal (month 4); Phase 3: 1 meal replacement + 2 self-prepared healthy meals (month 5); Phase 4: maintenance diet (months 6-8). The clinic/study dietitian will deliver the program in a weekly to fortnightly group VLCD initiation and support format held face-to-face at the university clinics metabolic clinic campus. This is already delivered as part of standard of care in our program. Optifast meal replacements will consist of an assortment of bars, shakes (made in water), desserts and soups. All meal replacements have nutritionally equivalent composition of carbohydrates, fat and protein and are nutritionally interchangeable between the different forms (e.g., bars = soups = desserts = shakes). The meal replacements come in a variety of flavours (bars: chocolate, cereal, cappucino); shakes: strawberry, vanilla, banana, chai, coffee, caramel; soups: tomato, vegetable, chicken; desserts - chocolate, vanilla). As per our protocol (see attached), patients will be initiated on varying intensities of meal replacements throughout phases 1 to 3 and provided with a detailed participant handbook which includes meal plans and a list of allowable fluids, fruits, vegetables, fats and proteins during each stage of the program as per standard of care. This information is based on published material provided by Nestle Health Science support material and the Baker Heart and Diabetes Institute handbook available online (https://baker.edu.au/-/media/documents/fact-sheets/Baker-Institute-factsheet-VLED-program.ashx?la=en). Additional foods allowed in the intervention (e.g., fruit, salads, tuna, yoghurt) are purchased and prepared by the patient at their own cost as part of their routine grocery shopping (however meal replacements are provided free of charge). Patients are asked in group sessions to note the number of meal replacements to the study clinician and dietitian and adherence will be monitored at each clinic visit through interview. The maintenance diet phase will be delivered in line with the Australian Healthy Eating Guideline (available online: https://www.eatforhealth.gov.au/guidelines/australian-guide-healthy-eating). Adherence will be determined on the WALI questionnaire and Food Intake Survey performed at the end of the study. PLUS patients will be given education by the study diabetes educator to teach self-administration of GLP-1 RA (dulaglutide 1.5 mg subcutaneously weekly, Trulicity®). This medication is TGA and PBS approved for the treatment of type 2 diabetes. Trulicity is delivered as a single 1.5 mg weekly subcutaneous injection using a prefilled pen, administered to the abdomen or thighs once a week. The patient will be taught self-injection by the clinic/study diabetes educator. Note, this is standard of care for prescribing these PBS subsidised and TGA approved medications. Adherence to the GLP-1 RA therapy will be monitored from the prescription record kept by the partner pharmacy and delivered to the study coordinator on a monthly basis.