DiRECT-Aus General Practitioners
Are you a GP in a practice participating in DiRECT-Aus?
Thank you for taking part in this study. If you would like additional information to support you and your patients, you can contact us at 1300 234 736 or email@example.com.
If you are interested in enrolling your patients into DiRECT-Aus, we welcome the opportunity to work with your patients to achieve positive outcomes. As a GP in DiRECT-Aus, you play an important role.
What role do you, the GP, play?
As the GP, you will play a key role in working with patients taking part in the trial. You will continue to provide routine diabetes care while also ensuring the safety of your patients. You may do this through:
- determining patient’s eligibility based on the inclusion and exclusion criteria
- reviewing blood work
- In collaboration with the study dietitian, taking patients off their diabetes medication and reducing or ceasing blood pressure medication
- restarting patients on medication, per clinical practice guidelines
- engaging in ongoing monitoring and support
- providing routine medical appointments and blood work, per clinical practice guidelines
Please ensure that your patients meet the eligibility criteria, listed below.
It is your role, as the GP, to determine final eligibility for patients wanting to take part in DiRECT-Aus. You will determine eligibility based on the following inclusion and exclusion criteria:
- men and women age 20-65 years
- type 2 diabetes for 0-6 years, based on Australian diagnostic criteria
- HbA1c ≥48mmol/mol (≥6.5%) at study entry if on diet alone or metformin alone
- BMI ˃27 kg/m²
- current insulin use
- recent routine HbA1c ≥10%
- weight loss of >5kg within the last 6 months
- recent eGFR <45ml/min/1.73²
- substance abuse
- known cancer
- myocardial infarction within previous 6 months
- severe or unstable heart failure defined as equivalent to the New York Heart Association (NYHA):
- Grade 3 – marked limitation of physical activity. Comfortable at rest, but less than ordinary activity causes fatigue, palpitation or breathlessness and
- Grade 4 – unable to carry out any physical activity without discomfort. Symptoms of cardiac insufficiency at rest. If any physical activity is undertaken, discomfort is increased.
- learning difficulties
- current treatment with anti-obesity drugs
- diagnosed with eating disorder or purging
- pregnant/considering pregnancy
- patients with unstable mental illness
- people currently participating in another clinical research trial
- Allergy to Optifast or any of its ingredients
We have put together a list of common, frequently asked questions. If you can’t find the answer to your question, please contact us at 1300 234 736 or firstname.lastname@example.org.
Q: What if a patient complains of dizziness, tiredness, headaches or lack of motivation after starting the VLED?
A: Check blood pressure and assess blood pressure medication and adjust, as needed.
It’s also important to remember that a VLED may lead to feelings of tiredness, headache and lack of motivation, particularly in the first few days of total. These symptoms generally improve with time.
Q: What if a patient complains of hunger after starting total diet replacement.
A: Feeling hungry is normal after starting the total diet replacement phase. It usually takes a few days up to a week for the body to convert to using ketones for energy (ketosis). Ketosis will help supress the appetite. Encourage patients to speak with the study dietitian, who will be able to trouble shoot and find solutions.
Q: What if a patient complains of diarrhoea, after starting the VLED?
A: This may happen for some patients. If it continues for longer than a week, explore options and encourage patients to speak with the study dietitian. She may be able to suggest alternative Optifast products that may be better tolerated.
Q: What if a patient is experiencing constipation after starting the total diet replacement phase?
A: Going to the toilet less often may happen as patients are consuming less food. Encourage patients to eat fibre from the allowed non-starchy vegetables and drink plenty of water or other allowed fluids. The study dietitian will be able to provide suggestions to improve constipation.
Q: What if a patient wants to stop the VLED before the end of the total diet replacement phase?
A: Encourage patients to review with the study dietitian. She will be able to trouble shoot problems and identify reasons for wanting to stop the total diet replacement phase early. If you identify major concerns, use best practice to assist patients.
Q: What if a patient is not losing weight as planned?
A: Weight loss will vary from patient to patient. Assess the patient’s current routine in line with the protocol and encourage patients to speak to the study dietitian. The dietitian will be able to assess weight loss and address concerns around weight loss.
Q: What if a patient tells you that they are not following the protocol as prescribed?
A: Following the protocol as prescribed will give patients the best possibility of achieving the desired weight loss and metabolic outcomes. Encourage patients to stick to the protocol and also speak with the study dietitian, who can help explore reasons for not following the protocol and find solutions.
Q: What are other side effects a patient may experience with a VLED?
A: Patients may be at increased risk of cholecystitis while on the total diet replacement phase. It is important that patients include 1 tsp of vegetable oil (like olive oil) per day to stimulate emptying of the gallbladder.
Patients may experience bad breath, due to ketosis. Encourage patients to carry sugar-free breath mints or chewing gum or drink plain, sugar-free peppermint or mint tea. The study dietitian will be able to provide ideas to manage bad breath.
Patients may experience tiredness, hunger, fatigue and lack of motivation, especially after first commencing the total diet replacement phase. This is normal and usually improves over time.
Q: How long will a patient stay on the VLED?
A: Most patients will stay on the VLED for 12 weeks, but this may be adjusted due to individual circumstances. It is important that the study dietitian move patients from one diet phase to the next.
Q: What happens if a patient regains weight?
A: It is important that patients see the study dietitian for all of their visits. The study dietitian will evaluate weight and be able to provide a rescue package, or meal replacement shake plus further instructions, for patients regaining weight.
Q: What if a patient is losing weight too quickly?
A: Patients may lose weight quite rapidly after starting the VLED. The study dietitian will be able to assess weight loss and stop the total diet replacement if the BMI drops too low. Encourage patients to attend all of their visits with the study dietitian.
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