Outcome
Type |
Measure |
Description |
Time frame |
Safety issue |
Other |
Carbohydrate intake |
in grams/day |
screening, 3 weeks, 6 weeks, 3 months, 6 months, 9 months, 12 months |
|
Other |
Energy intake from carbohydrates |
% of total energy intake |
screening, 3 weeks, 6 weeks, 3 months, 6 months, 9 months, 12 months |
|
Other |
Daily energy intake of participants |
kcal/day |
screening, 3 weeks, 6 weeks, 3 months, 6 months, 9 months, 12 months |
|
Other |
Frequency of intake of different foods measured by a Food frequency questionnaire (FFQ) |
The participants will fill in how frequent they consume 132 different food items. The available frequency responses are: 0/month, 1-3/month, 1-2/week, 3-4/week, 5-6/week, 1/day, 2/day, 3+/day. |
screening, 6 months,12 months |
|
Primary |
Change in insulin use |
measured in international units (IU) and percentage. |
screening, day 0, 3 weeks, 6 weeks, 3 months, 6 months, 9 months, 12 months |
|
Secondary |
Change in HbA1c |
mmol/mol |
screening, 3 weeks, 6 weeks, 3 months, 6 months, 9 months, 12 months |
|
Secondary |
Change in concentration of total cholesterol |
mmol/L |
screening, 3 months, 6 months, 9 months, 12 months |
|
Secondary |
Change in concentration of triglycerides |
mmol/L |
screening, 3 months, 6 months, 9 months, 12 months |
|
Secondary |
Change in concentration of HDL-cholesterol |
mmol/L |
screening, 3 months, 6 months, 9 months, 12 months |
|
Secondary |
Change in concentration of LDL-cholesterol |
mmol/L |
screening, 3 months, 6 months, 9 months, 12 months |
|
Secondary |
Ratio of LDL/HDL |
absolute number |
screening, 3 months, 6 months, 9 months, 12 months |
|
Secondary |
Concentration of glucagon |
pmol/L |
screening, 3 months, 6 months, 9 months, 12 months |
|
Secondary |
Change in markers of glycemic variability (TIR, TAR, TBR, mean sensor glucose with SD, CV) |
mmol/L |
screening, 3 months, 6 months, 9 months, 12 months |
|
Secondary |
Change in weight |
kg |
screening, 3 weeks, 6 weeks, 3 months, 6 months, 9 months, 12 months |
|
Secondary |
Change in BMI |
kg/m^2 |
screening, 3 weeks, 6 weeks, 3 months, 6 months, 9 months, 12 months |
|
Secondary |
Change in abdominal circumference |
cm |
screening, 3 weeks, 6 weeks, 3 months, 6 months, 9 months, 12 months |
|
Secondary |
Change in concentration of p-creatinine |
micromol/L |
screening, 3 months, 6 months, 9 months, 12 months |
|
Secondary |
Change in estimated Glomerular Filtration Rate (eGFR) |
mL/min/1,73 m2 |
screening, 3 months, 6 months, 9 months, 12 months |
|
Secondary |
Change in microalbuminuria |
morning U-Alb/Crea (mg/mmol) |
screening, 3 months, 6 months, 9 months, 12 months |
|
Secondary |
Concentration of Insulin-like Growth Factor 1 (IGF-I) |
microg/L |
screening, 3 months, 6 months, 9 months, 12 months |
|
Secondary |
Concentration of Insulin-like Growth Factor - binding protein 1 (IGFBP-1) |
microg/L |
screening, 3 months, 6 months, 9 months, 12 months |
|
Secondary |
Concentration of leptin |
microg/L |
screening, 3 months, 6 months, 9 months, 12 months |
|
Secondary |
Concentration of adiponectin |
mg/L |
screening, 3 months, 6 months, 9 months, 12 months |
|
Secondary |
Concentration of interleukin 6 (IL-6) |
ng/L |
screening, 3 months, 6 months, 9 months, 12 months |
|
Secondary |
Concentration of high sensitivity c-Reactive Protein (Hs-CRP) |
mg/L |
screening, 3 months, 6 months, 9 months, 12 months |
|
Secondary |
Measurement of lipopolysaccharides (LPS) activity using the Limulus Amebocyte Lysate (LAL) assay |
measured in endotoxin units (EU)/ml |
screening, 3 months, 6 months, 9 months, 12 months |
|
Secondary |
Concentration of glutaredoxin 1 (GRX-1) |
|
screening, 3 months, 6 months, 9 months, 12 months |
|
Secondary |
Concentration of Oxidized LDL |
|
screening, 3 months, 6 months, 9 months, 12 months |
|
Secondary |
Total Antioxidant Capacity (TAC) |
|
screening, 3 months, 6 months, 9 months, 12 months |
|
Secondary |
Concentration of reactive oxygen species (ROS) |
|
screening, 3 months, 6 months, 9 months, 12 months |
|
Secondary |
Plasma metabolites assessed by untargeted liquid chromatography - mass spectrometry (LC-MS) metabolomics |
|
screening, 3 months, 6 months, 9 months, 12 months |
|
Secondary |
Score from the Short Form 36 (SF-36) questionnaire |
The Short Form (36) Health Survey is a 36-item, patient-reported survey of patient health.The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. |
screening, 3 weeks, 6 weeks, 3 months, 6 months, 9 months, 12 months |
|
Secondary |
Score from the Well-being Questionnaire-12 (WBQ-12) |
This questionnaire is designed to measure general well-being, including negative well-being, energy and positive well-being. The negative well-being scale score (range 0-12) is reversed and then summed with the Energy score (range 0-12) and Positive score (range 0-12) to produce a general well-being score (range 0-36). The higher the score the greater the sense of general well-being. |
screening, 3 weeks, 6 weeks, 3 months, 6 months, 9 months, 12 months |
|
Secondary |
Score from the Diabetes Treatment Satisfaction Questionnaire (DTSQ) |
The DTSQ has been developed to assess patient satisfaction with diabetes treatment. The questionnaire is composed of two different factors. The ?rst factor assesses treatment satisfaction and consists of six questions and the second factor consists of two questions, which assess the burden from hyper- and hypoglycemia. Treatment satisfaction is assessed as the sum of the scores of the six questions on the ?rst factor (total score 36), with a higher score indicating higher treatment satisfaction. |
screening, 3 weeks, 6 weeks, 3 months, 6 months, 9 months, 12 months |
|
Secondary |
Time taken to complete the Trail making test A+B |
The Trail Making Test is a neuropsychological test of visual attention and task switching. It consists of two parts in which the subject is instructed to connect a set of 25 dots as quickly as possible while still maintaining accuracy. The time taken to complete the test is used as the primary performance metric, measured in seconds and or minutes. |
screening, 3 weeks, 6 weeks, 3 months, 6 months, 9 months, 12 months |
|