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New treatment option for Pediatric Obesity
Official title Low EnerGy DiEt iN Adolescents With Obesity and Type 2 Diabetes: The LEGEND Study
ClinicalTrials.gov ID: NCT06572345
What this study is testing
- What it's testing
- This is a multicentre, single-arm, feasibility study in adolescents with T2DM and obesity to investigate the recruitment and retention rates to a study using Low Energy Diets(LED). It will also provide estimates of weight loss needed to bring about remission to inform a larger randomised study.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 12 to 17
You may be able to join if
- 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. To allow for the day-to-day variation in HbA1C and differences between point...
- Aged 12 to 17 years old.
- BMI ≥981st centile (+2 SD) for age and sex (UK90 growth reference data).
You likely can't join if
- LED intervention
- HbA1C greater than 82mmol/mol (to allow for the variation in HbA1c differences).
- 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...
- Secondary diabetes (post bone marrow transplant/chemotherapy).
- Significant psychiatric co-morbidity.
See the full eligibility criteria
Who can join
- 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. To allow for the day-to-day variation in HbA1C and differences between point of care laboratory tests, -2 or +2 mmol/mol in the HbA1C result will...
- Aged 12 to 17 years old.
- BMI ≥981st 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 for LED intervention, with the following...
- 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 ≥91st 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.
What rules you out
- LED intervention
- HbA1C greater than 82mmol/mol (to allow for the variation in HbA1c differences).
- 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...
- Participation in another treatment 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...
- Participation in another treatment 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.
The study team makes the final eligibility decision.
Where it's taking place
- Nottingham, United Kingdom
Compensation & support
Some study costs may be covered.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 12 years to 17 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Nottingham, United Kingdom. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.