Low EnerGy DiEt iN Adolescents With Obesity and Type 2 Diabetes: The LEGEND Study

Launched by NOTTINGHAM UNIVERSITY HOSPITALS NHS TRUST · Aug 21, 2024

Keywords

ClinConnect Summary

The LEGEND Study is a clinical trial designed to explore how effective a Low Energy Diet (LED) might be for teenagers aged 12 to 17 who have both obesity and Type 2 Diabetes (T2DM). The main goal is to see how well we can recruit and keep participants in this study, as well as to estimate how much weight loss is needed for some young people to potentially go into remission from diabetes. The study will also involve interviews with some participants and their parents to understand their experiences, as well as those who chose not to participate, to learn about their reasons and any challenges they faced.

To be eligible for this study, participants must have a confirmed diagnosis of T2DM and a body mass index (BMI) that is significantly higher than average for their age and sex. They should also be willing to commit to the diet and attend follow-up visits. The study is not yet recruiting, but it aims to gather important information that could help in planning larger trials in the future. It’s a chance for young people to contribute to research that could improve treatments for diabetes and obesity.

Gender

ALL

Eligibility criteria

• • Inclusion criteria
• • LED intervention
• • Diagnosis of T2DM (defined as an HbA1C ≥48mmol/mol, in the absence of features of type 1 or monogenic/syndromic diabetes).
• • Current HbA1C ≥48 (or ≥42 on antidiabetic medication) and ≤ 80 mmol/mol.
• • Aged 12 to 17 years old.
• • BMI ≥98th centile (+2 SD) for age and sex (UK90 growth reference data).
• * Informed consent:
• • Received from the young person (age 16-17) OR
• • Received from young person's parent/carer, with patient assent (age 12-15).
• • Willing to engage in and commit to low energy diet, FR and weight management phases including follow-up and attending study visits.
• • LED Intervention Interviews
• The same interview inclusion criteria for LED intervention, with the following additional requirements:
• Patients:
• * Informed consent:
• • Received from the young person (age 16-17) OR
• • Received from young person's parent/carer, with patient assent (age 12-15).
• • Willing to take part in a qualitative interview alongside a parent/carer.
• Relative/Carer:
• • A relative/carer for a young person meeting the above LED participant eligibility criteria.
• • Informed consent from the relative/carer to participate in the interview.
• • Willing to take part in a qualitative interview alongside the young person.
• • Non-LED Qualitative Interview only participants
• • Diagnosis of T2DM (defined as an HbA1C ≥48mmol/mol, in the absence of features of type 1 or monogenic/syndromic diabetes).
• • Current HbA1C ≥48 (or ≥42 on antidiabetic medication) and ≤80 mmol/mol.
• • Aged 12 to 17 years old.
• • BMI ≥98th centile (+2 SD) for age and sex (UK90 growth reference data).
• * Informed consent:
• • Received from the young person (age 16-17) OR
• • Received from young person's parent/carer, with patient assent (age 12-15).
• • Willing to take part in a qualitative interview alongside a parent/carer only.
• • HCPs
• • Registered HCP.
• • Experience of delivering this trial to the adolescents.
• • Willing to take part in a qualitative interview about undertaking motivational interviewing training and conducting/delivering the LED intervention study.
• • Exclusion criteria
• • LED intervention
• • 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 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 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.
• • HCPs
• • • None.