Table 5.
Summary of measures
| Measurement | Description | Baseline | 3 months | 6 months | 9 months | 12 months | 24 months |
|---|---|---|---|---|---|---|---|
| Blood sampling | Following an overnight fast (8 h) a blood sample is drawn. The plasma markers of metabolism (HbA1c*†‡, TC*, LDL*, HDL*, TG†, fasting insulin*† and glucose*†) will be analysed | Ѵ | Ѵ | Ѵ | Ѵ | Ѵ | – |
| Medications | Dose of antidiabetic*, lipid* and blood pressure lowering* medications | Ѵ | Ѵ | Ѵ | Ѵ | Ѵ | – |
| Adverse events | Major hypoglycaemic episodes*, cardiovascular events*, acute* and overuse* injuries related to the intervention component 1 | Ѵ | Ѵ | Ѵ | Ѵ | Ѵ | – |
| Glucose tolerance | Following an overnight fast (8 h) and after a 48 h medication and training pause, an antecubital intravenous line is placed and a standard 75 g oral glucose tolerance test will be performed. Blood will be drawn at the following time points: 0 (baseline), 15, 30, 60, 90 and 120 min. The plasma will be analysed for insulin*‡, C-peptide*‡ and glucose*‡. Area under the curve will be analysed*‡ | Ѵ | – | – | – | Ѵ | – |
| Physical fitness | Fitness*†‡ will be assessed by employing a progressive bicycle ergometer test protocol. Oxygen consumption will be assessed using continuous indirect calorimetric measurements (Cosmed, Italy) | Ѵ | – | – | – | Ѵ | – |
| Cognitive testing | Specific cognitive function areas (short-term memory, attention, executive functions, etc) will be tested using the CANTAB test package from Cambridge Cognition (Cambridge Cognition, UK) and BDNF-α is assessed from blood serum | Ѵ | – | – | – | Ѵ | – |
| Depression | Characteristics, attitudes and symptoms of depression will be assessed using the Beck Depression Inventory51 | Ѵ | – | – | – | Ѵ | – |
| Well-being, functional ability and motivation | Functional health and well-being will be assessed using the SF-36.52 Positive and negative effect on separate subscales will be assessed using the GMS. Dimensions of positive mental health, including emotional, psychological and social well-being, is measured using The Mental Health Continuum Short Form. To assess motivation for training, the BREQ-2 is employed | Ѵ | Ѵ | Ѵ | – | Ѵ | – |
| Dietary intake | A food frequency questionnaire is completed*53 | Ѵ | – | – | – | Ѵ | – |
| Body composition, anthropometry and blood pressure | Height*†‡§, weight*†‡§, waist and hip circumference will be measured by standard procedures. Dual X-ray absorptiometry (iDXA; Lunar, Madison, WI) and COREScan will be used to assess whole body composition*‡. Home-based diastolic* and systolic* blood pressure is assessed using an upper arm blood pressure monitor (Model BPM1C, Kinetik, UK) | Ѵ | Ѵ | Ѵ | Ѵ | Ѵ | Ѵ |
| Personal information | Age*†‡§, sex*†‡§, diabetes duration*†‡§ and educational level*†‡§ will be obtained using self-report | Ѵ | – | – | – | – | – |
| Physical activity | Information on the physical activity level*† will be obtained using questionnaire RPAQ | Ѵ | – | – | – | Ѵ | – |
| Personality type | Two questionnaires regarding personality, the NEO-Five Factor Inventory and a SES are incorporated¶54 55 | Ѵ | – | – | – | Ѵ | – |
| Sleep quality, disturbances, fatigue and sleepiness | Cardiorespiratory monitoring is used to measure the prevalence of obstructive sleep apnoea†. Participants complete sleep diaries for 2 weeks after each cardiorespiratory monitoring in order to record and describe potential changes in their sleep. The ESS† and the MFI† are employed to measure daytime sleepiness. Sleep quality is measured using the PSQI† | Ѵ | – | Ѵ | – | Ѵ | Ѵ |
| Arterial function¶ | An ultrasound system equipped with vascular software for two-dimensional imaging, colour and spectral Doppler is used to assess flow mediated dilation and shear stress in the femoral artery§ | Ѵ | – | – | – | Ѵ | – |
*Article 1: The effects of a head-to-head comparison of intensive life style intervention (U-TURN) versus standard glucose lowering medications in patients with type 2 diabetes mellitus: an assessor-blinded, parallel group, randomised trial.
†Article 2: The effects of the U-TURN lifestyle intervention on sleep quality and sleep apnoea in patients with type 2 diabetes.
‡Article 3: Predictors for improvements in glycaemic control after a comprehensive lifestyle intervention; A sub-study to the randomised trial study U-TURN.
§Article 4: Effect of lifestyle intervention on endothelial function in patients with type 2 diabetes assessed by flow mediated dilatation; A sub-study to the randomised trial U-TURN.
¶Measured in a subset of the sample (N=40).
–, not assessed; BREQ-2, Behavioral Regulation In Exercise Questionnaire 2; ESS, Epworth Sleepiness Scale; GMS, Global Mood Scale; HbA1c, glycated haemoglobin; HDL, high-density lipoprotein; LDL, low-density lipoprotein; MFI, Multidimensional Fatigue Inventory; PSQI, Pittsburgh Sleep Quality Index; RPAQ, Recent physical activity questionnaire; SES, Sensation Seeking Scale; TC, total cholesterol; TG, triglyceride; Ѵ, assessed.