| Outcome Measures: |
Primary: type 2 diabetes, development of type 2 diabetes defined by fasting glycaemia, oral glucose tolerance test and/or HbA1c according to the ADA criteria, by 160 weeks | Secondary: medication for diabetes, percentage need for rescue therapy for diabetes, by 160 weeks|prediabetes, percentage prediabetes based on fasting glycaemia, oral glucose tolerance test and/or HbA1c (ADA criteria), by 160 weeks|normoglycaemia, percentage regression to normoglycaemia, based on fasting glycaemia, oral glucose tolerance test and/or HbA1c (ADA criteria), by 160 weeks|BMI, mean BMI (Kg/m2), by 160 weeks|waist circumference, mean waist circumference (cm), by 160 weeks|waist/hip ratio, waist/hip circumference ratio, by 160 weeks|5% weight loss, percentage weight loss ≥5%, by 160 weeks|10% weight loss, percentage weight loss ≥10%, by 160 weeks|15% weight loss, percentage weight loss ≥15%, by 160 weeks|body fat percentage, percentage body fat measured by bioelectrical impedance analysis, by 160 weeks|HOMA-B index, Beta-cell function measured by the HOMA-B index, by 160 weeks|insulinogenic index, Beta-cell function measured by the by the insulinogenic index divided by HOMA-insulin resistance index, by 160 weeks|ISSI-2 index, Beta-cell function measured by theby the insulin-secretion sensitivity-2 index, by 160 weeks|the Stumvoll index., Beta-cell function measured by the Stumvoll index., by 160 weeks|Matsuda index, whole body Insulin sensitivity measured by the insulin sensitivity index of Matsuda, by 160 weeks|HOMA-IR, the reciprocal of the homeostasis model assessment of insulin resistance (1/HOMA-IR), by 160 weeks|metabolic syndrome, percentage of the metabolic syndrome based on the WHO criteria, by 160 weeks|Hypertension, percentage blood pressure ≥140/90mmHg, by 160 weeks|heart rate, mean heart rate, by 160 weeks|LDL cholesterol, percentage LDL cholesterol ≥100mg/dl, by 160 weeks|Triglycerides, percentage triglycerides ≥150mg/dl, by 160 weeks|hypoglycaemia, percentage with hypoglycaemia (\<54mg/dl), by 160 weeks|gastro-intestinal side effects, percentage nausea, vomiting or diarrhea, by 160 weeks|self-reported quality of life, health-related quality of life by SF-36 questionnaire, by 160 weeks|symptoms of depression, the 20-item Center for Epidemiologic Studies-Depression (CES-D) questionnaire, by 160 weeks|anxiety, six-item short-form of the State-Trait Anxiety Inventory questionnaire on anxiety (STAI), by 160 weeks|Diabetes risk perception, Diabetes Risk perception questionnaire, a validated questionnaire to evaluate the perception to develop diabetes, by 160 weeks|sleep quality, The validated Pittsburg sleep quality index to evaluate sleep quality, by 160 weeks|diabetes remission, diabetes remission rate after treatment stop, defined by fasting, OGTT and/or HbA1c, by 172-184 weeks (3-6 months after end of therapy)
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| Locations: |
OLV-Aalst-Asse, Aalst, Belgium|UZA, Antwerp, Belgium|ZNA,, Antwerp, Belgium|AZ St Jan Brugge, Brugge, Belgium|Erasme, Brussel, Belgium|UZ Brussel, Brussel, Belgium|Jan Yperman, Ieper, Belgium|AZ Groeninge Kortrijk, Kortrijk, Belgium|UZ Leuven, Leuven, Belgium|CHU de Liège, Liège, Belgium|Centre Hospitalier Mouscron, Mouscron, Belgium|Vitaz, Sint-Niklaas, Belgium|AZ Turnhout, Turnhout, Belgium
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