Table 1 Eligibility of study participants
Inclusion criteria | Exclusion criteria |
|---|---|
Men and women aged 18–80 years | HbA1c: ≥ 75 mmol/mol with no glucose-lowering medications |
Diagnosed with diabetes type 2 and/or HbA1c ≥ 48 mmol/mol if no treatment with anti-diabetic medication and/or use of anti-diabetic medication | HbA1c: ≥ 64 mmol/mol with mono glucose-lowering therapy (if compliant with the prescription) |
Caucasian | HbA1c: ≥ 57 mmol/mol with ≥ dual glucose-lowering therapy (if compliant with the prescription) |
No diagnose of type 1 diabetes, MODY-diabetes, type 1½ diabetes or LADA-diabetes | eGFR < 60 mL/min |
T2D duration < 7 years | Macroalbuminuria at pre-screening |
No treatment with insulin | Clinical or biochemical signs of hypothyroid disease |
No use of sulphonylurea-based drugs | Biochemical sign of other major diseases |
Body Mass Index (BMI) > 27 kg/m2 and < 40 kg/m2 | Presence of circulating glutamatdecarboxylase anti body (GAD) 65 |
No known or signs of intermediate or severe microvascular complications to diabetes (retino-, neuro- or nephropathy) | Objective findings that contraindicates participation in intensive exercise (Pedersen and Saltin 2006) |
No known cancer | Anamnestic findings that contraindicates participation in the study (Pedersen and Saltin 2006) |
No lung disease, other than asthma that can be managed with beta2-agonists and does not exhibit seasonal variation. | Unable to allocate the needed time to fulfil the intervention |
No known cardiovascular disease | Language barrier, mental incapacity, unwillingness or inability to understand and be able to complete the interventions |
No known hyperthyroid disease | HbA1c: ≥ 75 mmol/mol with no glucose-lowering medications |
No changes in hypothyroid disease treatment within the last 3 months prior to enrolment | HbA1c: ≥ 64 mmol/mol with mono glucose-lowering therapy (if compliant with the prescription) |
No known liver disease—defined as ALAT or ASAT elevated three times above upper limit. | HbA1c: ≥ 57 mmol/mol with ≥ dual glucose-lowering therapy (if compliant with the prescription) |
No known autoimmune disease | eGFR < 60 mL/min |
No psoriasis disease requiring systemic treatment or cutaneous elements bigger than a total area of 25 cm2 | Macroalbuminuria at pre-screening |
No other endocrine disorder causing obesity | Clinical or biochemical signs of hypothyroid disease |
No current treatment with anti-obesity medication | Biochemical sign of other major diseases |
No current treatment with anti-inflammatory medication | Presence of circulating glutamatdecarboxylase anti body (GAD) 65 |
No weight loss of > 5 kg within the last 6 months | Objective findings that contraindicates participation in intensive exercise (Pedersen and Saltin 2006) |
No changes in symptoms or anti-depressive medication 3 months prior to enrolment. | Anamnestic findings that contraindicates participation in the study (Pedersen and Saltin 2006) |
No diagnose of psychiatric disorder or treatment with anti-psychotic medication | Unable to allocate the needed time to fulfil the intervention |
No history of suicidal behaviour or ideations within the last 3 months prior enrolment | Language barrier, mental incapacity, unwillingness or inability to understand and be able to complete the interventions |
No previous surgical treatment for obesity (excluding liposuction > 1 year prior to enrolment) | |
Not pregnant/considering pregnancy | |
No functional impairments that prevents the performance of intensive exercise | |
Accept of medical regulation by the study endocrinologist | |
Inactivity, defined as < 1,5 h of structured physical activity per week at moderate intensity or cycling < 30 min/5 km per day at moderate intensity (moderate intensity = out of breath but able to speak) | |
No participation in other research intervention studies |