Type 2 diabetes, non-diabetic hyperglycaemia, impaired glucose regulation (IGR) Nutritional, Metabolic, Endocrine Type 2 diabetes mellitus
Conditions
Interventions
The study design involves an NHS primary care based screening programme to detect and screen 10,000 subjects at increased risk of Type 2 diabetes, with randomisation of 'pre diabetes' groups into thre
Sponsors
Norfolk and Norwich University Hospital NHS Trust (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Fasting plasma glucose 5.6 - 6.0 mmol/l AND HbA1c 42 - 47 inclusive on two occasions, OR fasting plasma glucose 6.1 - 6.9 inclusive on two occasions, both categories for the diabetes prevention project 2. Fasting plasma glucose > or = to 7.0 mmol/l on two occasions, OR HbA1c > or = to 48 mmol/mol on two occasions for the screen-detected Type 2 diabetes project 3. These criteria are gender independent, but main search criteria for subjects through primary care databases is 40 - 80 years old
Exclusion criteria
Exclusion criteria: 1. Not able to provide GP details i.e. not registered with a GP or unwilling for their GP to be contacted 2. Unable to give informed consent due to lack of capacity through severe mental health, learning difficulties or significant cognitive impairment 3. Self-reported conditions which could adversely affect the trial results or patient clinical well being such as: 3.1. Terminal illness 3.2. Antipsychotic medication, which may affect glucose tolerance 3.3. High dose oral steroids (> 4 weeks or > 7.5 mg) 3.4. Active treatment for malignancy 3.5. Stage IV renal impairment or ongoing renal dialysis 3.6. Pregnant or lactating 3.7. Stage IV NYHA cardiac failure 4. Taking part in any research study which involves a dietary or lifestyle change intervention (exceptions are participants in observational research studies and EPIC*). Participation in other research studies will be assessed on an individual basis 5. Inability to attend or comply with the interventions or follow-up scheduling 6. Living with or related to someone in the programme team 7. GP advice on health grounds that the participant should not take part or be contacted
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Project 2 (prediabetes study): Progression to type 2 diabetes (T2DM), determined by fasting plasma glucose analysis and/or HbA1c analysis, at baseline, 4 months, 6 months, 12 months, 24 months, 36 months 40 months, 46 months (EXIT). Project 4 (diabetes study): Difference in mean HbA1c at timepoints and Quality and Outcomes Framework (QOF) scores for diabetes based on the diabetes QoF dataset. QOF – target is based on 7.5% (58mmol/mol and 10% (86mmol/mol) HbA1 thresholds – we describe % above and below these thresholds by arm. | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary outcome measures are measured at baseline, 4 months, 6 months, 12 months, 24 months, 36 months 40 months and 46 months: Project 2 (prediabetes study): 1. Change from baseline in HOMA estimate of insulin sensitivity 2. Change from baseline in HOMA estimate of B-cell function 3. Change from baseline in physical activity (objectively measured by accelerometer) 4. Change from baseline in physical activity (self-reported short form IPAQ questionnaire) 5. Change from baseline in resistance activity (self reported study specific questionnaire) 6. Change from baseline in dietary behaviour (self-reported by DBQ study specific designed questionnaire) change from baseline in weight 7. Change from baseline in BMI 8. Change from baseline in waist circumference 9. Change from baseline in body fat % 10. Change from baseline in body fat (kg) 11. Change from baseline in visceral fat 12. Change from baseline in WBQ12 13. Change from baseline in ADDQoL 14. Composite score of changes in weight, BMI, waist circumference and exercise levels Project 4 (diabetes study): 1. Change from baseline in HOMA estimate of insulin sensitivity 2. Change from baseline in HOMA estimate of B-cell function 3. Change from baseline in physical activity (objectively measured by accelerometer) 4. Change from baseline in physical activity (self-reported short form IPAQ questionnaire) 5. Change from baseline in resistance activity (self reported study specific questionnaire) 6. Change from baseline in dietary behaviour (self-reported by DBQ study specific designed questionnaire) 7. Change from baseline in weight 8. Change from baseline in BMI 9. Change from baseline in waist circumference, 10. Change from baseline in body fat % 11. Change from baseline in body fat (kg) 12. Change from baseline in visceral fat 13. Change from baseline in WBQ12 14. Change from baseline in ADDQoL 15. Change from baseline in EQ-5D 16. Change from baseline in DMSES 17. Change from baseline in DTSQs 18. Composite s | — |
Countries
England, United Kingdom
Outcome results
None listed