Introduction
Methods
Ethical, regulatory and legal considerations
Methods common to Study 1 and Study 2
Anthropometric and blood pressure
Blood omics
Beta cell function and insulin sensitivity
Microbiome assessment
Urine sample
MRI
Dietary assessment
Physical activity, sedentary behaviour and sleep assessment
Additional questionnaires
Central database
Statistical power
Prediabetic glycaemic deterioration (Study 1)
Study 1 rationale
Study 1 participant identification
Inclusion criteria |
• No treatment with insulin-sensitising, glucose-lowering or other antidiabetic drugs |
• Fasting capillary blood glucose <10 mmol/l at baseline |
• White European (self-report of parental ethnicity) |
• Age ≥35 and <75 years |
Exclusion criteria |
• Diagnosed diabetes of any type, HbA1c ≥6.5% (48 mmol/mol) or fasting plasma glucose ≥7.0 mmol/l or 2 h plasma glucose >11.0 mmol/l previously |
• For women, pregnancy, lactation or plans to conceive within the study period |
• Use of a pacemaker |
• Any other significant medical reason for exclusion as determined by the investigator |
Characteristic | All studies (n = 6,136) | Hoorn (n = 1,345) | KORA S4/F4 (n = 904) | Inter99 (n = 3,887) |
---|---|---|---|---|
Age (years) | 52 (30–79) | 60 (50–77) | 64 (55–74) | 46 (30–61) |
Sex (% male) | 49% | 46% | 51% | 50% |
HbA1c at follow-up (%) | 5.66 ± 0.44 | 5.47 ± 0.62 | 5.64 ± 0.41 | 5.73 ± 0.34 |
HbA1c at follow-up (mmol/mol) | 38.4 ± 4.8 | 36.3 ± 6.8 | 38.1 ± 4.5 | 3.91 ± 3.7 |
Follow-up duration (years) | 6 (4–8) | 6.5 (4–8) | 7 (6.5–8) | 5.5 (5–6.5) |
Study 1 screening examination
Study 1 baseline examination
Study 1 measurements between core examinations
Study 1 follow-up examinations at 18 and 36 months
New-onset diabetes glycaemic deterioration (Study 2)
Study 2 rationale
Study 2 participant identification
Inclusion criteria |
• Patients diagnosed with type 2 diabetes not less than 6 months and not more than 24 months before baseline examination |
• Management by lifestyle with or without metformin therapy |
• All HbA1c <7.6% (<60 mmol/mol) within previous 3 months |
• White European |
• Age ≥35 and <75 |
• Estimated GFR >50 ml/min |
Exclusion criteria |
• Type 1 diabetes |
• A previous HbA1c >9.0% (>75 mmol/mol) |
• Prior treatment with insulin or an oral hypoglycaemic agent other than metformin |
• BMI <20 or >50 kg/m2
|
• Pregnancy, lactation or plans to conceive within the study period |
• Any other significant medical reason for exclusion as determined by the investigator |