Type 2 diabetes Nutritional, Metabolic, Endocrine Type 2 diabetes mellitus
Conditions
Interventions
Following the completion of their baseline assessment, the participant will be randomly allocated equally to one of two groups using a secure web-based service. Randomisation will be stratified by tri
Sponsors
University of Leicester
Eligibility
Sex/Gender
All
Age
16 Years to 45 Years
Inclusion criteria
Inclusion criteria: 1. Age 16 to 45 years, inclusive 2. Type 2 diabetes diagnosed before the age of 40 years; confirmed by medical history with/without specialist investigations (e.g., antibodies) 3. HbA1c >= 6.0% (>= 42 mmol/mol) within 3 months of trial enrolment 4. Able to provide informed consent
Exclusion criteria
Exclusion criteria: 1. Diagnosed with other forms of diabetes (e.g., type 1 diabetes, monogenic diabetes [MODY], gestational diabetes or latent autoimmune diabetes in adults [LADA]) 2. Serious illness or event with life-expectancy <1 year or other significant illness which, in the opinion of a study clinician, precludes involvement 3. Planned major surgery 4. Requirement for renal replacement therapy 5. Current pregnancy, or actively trying to conceive 6. Unable or unwilling to provide informed consent 7. Current participation in a competing clinical trial (CTIMP, as determined by the study investigator)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in HbA1c from baseline to 52 weeks collected by venous blood sampling. | — |
Secondary
| Measure | Time frame |
|---|---|
| Current secondary outcome measures as of 02/01/2024: Measured at baseline, week 26, week 52, and week 104, unless specified otherwise 1. Glycaemic level: Change in HbA1c from baseline to 26 weeks and baseline to 104 weeks collected by venous blood sampling 2. Multimorbidity management and burden: Treatment burden using the Multimorbidity Treatment Burden Questionnaire (MTBQ) 3. Cardiometabolic and renal risk: 3.1. Total cholesterol and high-density lipoprotein collected by venous blood sampling 3.2. Kidney function measured using estimated glomerular filtration rate (eGFR) by venous blood sampling 3.3. Anthropometry and body composition (body weight, height, body mass index, lean body mass, and fat mass) measured by bioelectrical impedance 3.4. Systolic and diastolic blood pressure measured using an automated sphygmomanometer 4. Psychosocial wellbeing and self-management support: 4.1. Self-compassion measured using the Self-Compassion Scale (SCS) 4.2. Distress measured using the Problem Areas in Diabetes (PAID) questionnaire 4.3. Depression measured using the Patient Health Questionnaire (PHQ-9) 4.4. Stigma measured using the type 2 Diabetes Stigma Assessment Scale (DSAS-2) 4.5. Self-efficacy measured using the Diabetes Management Self-Efficacy Scale (DMSES) 5. Self-reported quality of life: 5.1. Health status and quality of life using the EQ-5D-5L questionnaire 5.2. Health-related quality of life across multiple domains using the Short Form 36 Health Survey Questionnaire (SF-36) 6. Health service resource utilisation and work productivity: 6.1. Healthcare service utilisation using the Modular Resource Use Measure (ModRUM) 6.2. Work productivity using the Work Productivity and Activity Impairment (WPAI) questionnaire 7. Physical activity: Device-measured daily steps using a wrist-worn accelerometer (optional to minimise participant burden) Exploratory measures: Measured at baseline and week 26 (* selected outcomes only), week 52, and week 104 1. Other measures rela | — |
Countries
England, United Kingdom
Contacts
Public ContactLisa;Tommy Moyes;Slater
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Outcome results
None listed