We'd like your feedback
Your feedback is important to us. It will help us improve the quality of the study information on this site. Please answer both questions.
Contact the study team using the details below to take part. If there are no contact details below please ask your doctor in the first instance.
Gemma
Boam
gemma.boam@nhs.net
Pooja
Sachdev
pooja.sachdev@nuh.nhs.uk
Katherine
Brooks
katherine.brooks3@nhs.net
Gemma
Boam
gemma.boam@nhs.net
Diabetes mellitusObesity and other hyperalimentation
This information is provided directly by researchers, and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information. In some summaries, you may come across links to external websites. These websites will have more information to help you better understand the study.
The number of under-18s with type 2 diabetes (T2DM) is rising alongside childhood obesity. It has a worse prognosis than type 1 diabetes at the same age. Serious medical problems occur sooner and progress more quickly. These include renal failure, nerve damage and blindness. Guidelines recommend children and families are supported to eat healthily and increase activity.
Low-calorie diets are effective in reversing T2DM in half of adults who lost 10-15 kg, by reduction of liver and pancreatic fat. Remission of T2DM results in improved quality of life and life expectancy for patients with large cost-savings for the NHS. Locally, we have worked with eight young people who lost 10kg on average.
This study will find out if a low-calorie diet is acceptable to under-18s with type 2 diabetes (T2DM). The low-calorie diet provides 800-1000kcal a day (with LED diets typically containing 800-1200kcal/day). The participant has special soups and shakes instead of their usual meals for several weeks. Participants can have a low-calorie meal each day instead of a meal replacement product at the study teams discretion. The young person’s own hospital team will carry out the study.
This study aims to find out:
To estimate recruitment and retention rates to inform a full randomised control trial of an LED for adolescents with T2DM.
To understand what the barriers and motivators are and how to optimise them.
To provide estimates of the weight loss needed to achieve remission.
To understand the positive and potential negative effects of a period of LED on the biological, psychological and social wellbeing of adolescents.
To identify pathways involved in the pathogenesis of T2DM in young people and prognostic markers of disease progression or response to intervention.
We will use the findings to plan a larger trial.
Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.
The recruitment start and end dates are as follows:
Type: Dietary;Imaging;
You can take part if:
You may not be able to take part if:
LED intervention and LED interview participants; • HbA1C greater than 80mmol/mol. • Presence of diabetes-related autoantibodies, as per local centre guidelines. • Confirmed mono-genetic cause of obesity (e.g. SIM1 mutation) or diabetes-associated syndrome such as Prader-Willi syndrome, Bardet-Biedl or Wolfram’s syndrome. • Secondary diabetes (post bone marrow transplant/chemotherapy). • Significant psychiatric co-morbidity. • Breastfeeding, pregnant or planning to conceive during the LED and FR phases (female participants will be advised on need for effective contraceptive methods during the 12-month study period, section 5.1.1.10). • Any other condition which, in the opinion of the study investigator, would make it inappropriate to undertake a period of LED. (All reasons for not approaching patients will be recorded and analysed anonymously. Cases can be discussed with the core study group if there is doubt). • Participation in another interventional trial within 6 months. • Informed consent and/or assent not received. • Pre-existing retinopathy. • Dietary avoidance (including, but not limited to, due to allergies, intolerances, religious reasons and lifestyle choices) to any ingredients in the meal replacement products, including lactose. • Previous scoliosis repair. Non-LED Qualitative interview only participant • HbA1C greater than 80mmol/mol. • Presence of diabetes-related autoantibodies, as per local centre guidelines. • Confirmed mono-genetic cause of obesity (e.g. SIM1 mutation) or diabetes-associated syndrome such as Prader-Willi syndrome, Bardet-Biedl or Wolfram’s syndrome. • Secondary diabetes (post bone marrow transplant/chemotherapy). • Significant psychiatric co-morbidity. • Breastfeeding, pregnant or planning to conceive during the LED and FR phases (female participants will be advised on need for effective contraceptive methods during the 12-month study period, section 5.1.1.10). • Any other condition which, in the opinion of the study investigator, would either make it inappropriate to undertake a period of LED. (All reasons for not approaching patients will be recorded and analysed anonymously. Cases can be discussed with the core study group if there is doubt). • Participation in another interventional trial within 6 months. • Informed consent and/or assent not received. • Pre-existing retinopathy. • Dietary avoidance (including, but not limited to, due to allergies, intolerances, religious reasons and lifestyle choices) to any ingredients in the meal replacement products, including lactose. • Previous scoliosis repair. HCP • None
Below are the locations for where you can take part in the trial. Please note that not all sites may be open.
Gemma
Boam
gemma.boam@nhs.net
Katherine
Brooks
katherine.brooks3@nhs.net
Gemma
Boam
gemma.boam@nhs.net
Pooja
Sachdev
pooja.sachdev@nuh.nhs.uk
The study is sponsored by NOTTINGHAM UNIVERSITY HOSPITALS NHS TRUST and funded by THE BRITISH DIABETIC ASSOCIATION .
Your feedback is important to us. It will help us improve the quality of the study information on this site. Please answer both questions.
Read full details
for Trial ID: CPMS 61533
You can print or share the study information with your GP/healthcare provider or contact the research team directly.
