Health TrialsbyHealthPanel

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

ConditionsPediatric ObesityType 2 Diabetes
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age12-17
SponsorNottingham University Hospitals NHS Trust

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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 be allowed in the current criteria if one of them is between or equal to 42-80mmol/mol.

Aged 12 to 17 years old.

BMI ≥981st centile (+2 SD) for age and sex (UK90 growth reference data).

Disqualifiers

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).

Trial design

Design model

Single group

Treatments tested in this trial

  • Low-energy diet

    Dietary supplement

    For the first 12 weeks during the LED, participants will have 4 meal replacement products each day. The following 12 weeks consists of a gradual reintroduction of food one meal at a time, in a structured stepwise progression, under the supervision of a dietitian. They will then undergo 28 weeks of weight maintenance to see if they are able to keep their weight stable.

  • Qualitive interview - LED participants

    Other intervention

    Semi-structured interviews with 10 of the LED participants and their relative/carer.

  • Qualitive interview - Participants declining LED

    Other intervention

    Semi-structured interviews with 10 participants who declined the LED, and their relative/carer.

  • Qualitive interview - Health Care Professionals (HCPs)

    Other intervention

    Semi-structured interviews with 10 HCPs involved in delivery of the trial.

Treatment groups

73 Participants
are divided into 1 treatment group
Group A: Low Energy Diet (LED)Experimental treatment 4 interventions

Trial outcomes

Primary outcomes

1

Proportion of potential participants that can be recruited to an LED intervention

Number of eligible participants identified compared to those consented, passed screening and started on LED intervention.

Time frame
12 months
2

Retention rate measured by by data availability for participant height.

Height obtained for the participant at: 1. End of LED phase (12 weeks) 2. End of FR phase (24 weeks) 3. End of maintenance phase (12 months)

Time frame
12 months
3

Retention rate measured by by data availability for participant weight.

Weight obtained for the participant at: 1. End of LED phase (12 weeks) 2. End of FR phase (24 weeks) 3. End of maintenance phase (12 months)

Time frame
12 months
4

Retention rate measured by by data availability for participant HbA1C.

HbA1C obtained for the participant at: 1. End of LED phase (12 weeks) 2. End of FR phase (24 weeks) 3. End of maintenance phase (12 months)

Time frame
12 months

Secondary outcomes

1

Proportion of participants that adhere to the LED

Defined by at least 5% weight loss at end of LED phase compared to baseline.

Time frame
12 weeks
2

Degree of weight loss achieved in those who adhere to the LED and if this is maintained at 12-months.

Weight as measured at end of LED phase (12 weeks), compared against weight as measured at baseline. Weight as measured at end of FR phase (24 weeks), compared against weight as measured at baseline. Weight as measured at end of maintenance (12 months) compared against weight at baseline. Weight as measured at end of FR compared against weight at the end of LED phase. Weight as measured at end of maintenance (12 months) compared against weight at the end of LED phase.

Time frame
12 months
3

Do those who adhere to the LED achieve remission? To determine the standard deviation of the proportion of participants that achieve remission (to estimate the sample size for a definitive randomised trial).

Percentage weight loss in those who achieve remission of T2DM defined as an HbA1C \<48 mmol/mol on two occasions at least 3 months apart, in the absence of anti-diabetes medication. This will help to determine the standard deviation of the proportion of participants that achieve remission, to enable an estimation of sample size for a future, definitive, randomised control trial.

Time frame
12 months
4

Do those who adhere to the LED achieve remission? To determine the standard deviation of the proportion of participants that achieve remission (to estimate the sample size for a definitive randomised trial).

Absolute weight loss in those who achieve remission of T2DM defined as an HbA1C \<48 mmol/mol on two occasions at least 3 months apart, in the absence of anti-diabetes medication. This will help to determine the standard deviation of the proportion of participants that achieve remission, to enable an estimation of sample size for a future, definitive, randomised control trial.

Time frame
12 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Nottingham University Hospitals NHS Trust

Lead sponsor

Diabetes UK

Collaborator

Source ClinicalTrials.gov
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