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

Summary

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. In addition a subgroup of participants and their parents/carers undertaking a period of LED will be interviewed to understand the participants experience of taking part. Two further groups will also be interviewed: participants and their parents/carers who have declined to take part in the LED to understand their motivations and barriers and healthcare practitioners who have participated in conducting the trial to understand their experience of the study.

Eligibility

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.

Conditions3

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