None listed
Conditions
Brief summary
This study seeks to show that Remission of T2D may be achieved by following a VLCD combined with lifestyle education over a 1 year period. Participants will undergo a meal replacement diet (VLCD) for 3 months with a gradual reintroduction to healthy eating. This will be done under the care of an Endocrinologist, dietitian and diabetes nurse. It is expected that participants will have an improvement in glycemic control with some achieving diabetes remission, leading to a reduction or cessation in diabetes medications after completion of the 1 year study
Interventions
30 participants will commence a very low calorie diet (VLCD) meal replacement for 3 months with a gradual re-introduction back to a healthy diet over a 12 month period. Participants will be required to purchase VLCD for the first month at a reduced cost of 25% of the retail cost. Thereafter, participants will be supplied with their VLCD free of charge. Participants will also attend 4 group education sessions on diabetes, diet and healthy lifestyle education. Participants will attend outpatient c
30 participants will commence a very low calorie diet (VLCD) meal replacement for 3 months with a gradual re-introduction back to a healthy diet over a 12 month period. Participants will be required to purchase VLCD for the first month at a reduced cost of 25% of the retail cost. Thereafter, participants will be supplied with their VLCD free of charge. Participants will also attend 4 group education sessions on diabetes, diet and healthy lifestyle education. Participants will attend outpatient clinic appointments at set intervals with an Endocrinologist, diabetes nurse and dietitian. Blood tests will be required 3 monthly until the end of the 12 month trial. VLCD is defined as approx. 800 calories per day Participants will be on VLCD meal replacement for 12 weeks. The following 4 weeks participants will be on approx. 1000 calories a day. This diet will be comprised of 2 VLCD meal replacements and 1 normal food meal The following 4 weeks after that people will be on 1 VLCD meal replacement and 2 normal food meals approx. 1200 calories per day. After this patients will be on normal healthy eating for 3 meals per day as per the dietitian recommendations related to calorie intake. The VLCD meal replacement will be Optislim Platinum VLCD. Participants will be weighed every 2 weeks during the initial phase, if there is weight gain people will be offered additional apt with dietitian for adherence strategies Group education will be the QLD health approved HELP program which is around healthy eating and physical activity. The diabetes nurse educators and dietitian will run the sessions in a meeting room setting. There will be approx. 5 participants per group. There will be 4 x 2hr group sessions in total occurring in the first 8 weeks of the participant commencing VLCD. It will be documented if participants don't attend. They will be offered 'catch up' sessions as sessions will be running regularly
Sponsors
Kathy Harrison
Study design
Allocation
Non-randomised trial
Primary purpose
Treatment
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
1. 18 – 65 years of age 2. Able to provide informed consent 3. Duration of type 2 diabetes of less than 6 years. 4. HbA1c > than 6.5% 5. BMI >27kg/m2
Exclusion criteria
1. Recent eGFR <30mls/min/1.73m2 2. Severe hepatic impairment 3. Alcohol or illegal substance dependence 4. Known cancer 5. Myocardial infarction within previous 6 months 6. Severe heart failure defined as equivalent to the NYHA grade 3 7. Diagnosed eating disorder or purging 8. Pregnancy and breastfeeding 9. Patients on insulin therapy 10. Patients on anti-obesity medications
Outcome results
None listed