Changes in heart rate variability (HRV) from baseline to week 6 will be compared to changes in HRV from week 6 to 12. Changes in HRV will be assessed from week 12 to 36.
HRV will be assessed by a Holter monitor (model RZ 153+12 from Rozinn) at baseline, week 6, 12 and 36.
Changes in diurnal blood pressure (DBP) from baseline to week 6 will be compared to changes in DBP from week 6 to 12. Changes in DBP will be assessed from week 12 to 36.
DBP will be assessed by a blood pressure monitor (model 90217 from Spacelabs Healthcare) at baseline, week 6, 12 and 36.
Changes in insulin sensitivity from baseline to week 6 will be compared to changes in insulin sensitivity from week 6 to 12. Changes in insulin sensitivity will be assessed from week 12 to 36.
Changes in insulin sensitivity will be measured using the minimal model technique based on a insulin modified frequently sample intravenous glucose test (IM-FSIGT) at baseline, week 6, 12 and 36.
Changes in beta-cell function from baseline to week 6 will be compared to changes in beta-cell function from week 6 to 12. Changes in beta-cell function will be assessed from week 12 to 36.
Changes in beta-cell function will be measured using the minimal model technique based on a insulin modified frequently sample intravenous glucose test (IM-FSIGT) at baseline, week 6, 12 and 36.
Changes in glucagon-like-petide-1 (GLP-1) at baseline to week 6 will be compared to changes in GLP-1 from week 6 to 12. Changes in GLP-1 will be assessed from week 12 to 36.
Changes in GLP-1 will be measured during a 4-hour (4-h) mixed meal test (MMT) at baseline, week 6, 12 and 36. GLP-1 will be expressed in pmol/L.
Changes in glucose-dependent insulinotropic polypeptide (GIP) at baseline to week 6 will be compared to changes in GIP from week 6 to 12. Changes in GIP will be assessed from week 12 to 36.
Changes in GIP will be measured during a 4-h MMT at baseline, week 6, 12 and 36. GIP will be expressed in pmol/L.
Changes in insulin-like growth factor-1 (IGF-1) at baseline to week 6 will be compared to changes in IGF-1 from week 6 to 12. Changes in IGF-1 will be assessed from week 12 to 36.
Changes in IGF-1 will be measured during a 4-h MMT at baseline, week 6, 12 and 36. IGF-1 will be expressed in ng/mL.
Changes in insulin-like growth factor-binding protein 1 (IGFBP-1) at baseline to week 6 will be compared to changes from week 6 to 12. Changes in IGFBP-1 will be assessed from week 12 to 36.
Changes in IGFBP-1 will be measured during a 4-h MMT at baseline, week 6, 12 and 36. IGFBP-1 will be expressed in ng/mL.
Changes in growth hormone (GH) at baseline to week 6 will be compared to changes in GH from week 6 to 12. Changes in GH will be assessed from week 12 to 36.
Changes in GH will be measured during a 4-h MMT at baseline, week 6, 12 and 36. GH will be expressed in ng/mL.
Changes in colecystokinin (CCK) at baseline to week 6 will be compared to changes in CCK from week 6 to 12. Changes in CCK will be assessed from week 12 to 36.
Changes in CCK will be measured during a 4-h MMT at baseline, week 6, 12 and 36. CCK will be expressed as pmol/L.
Changes in peptide YY (PYY) at baseline to week 6 will be compared to changes in PYY from week 6 to 12. Changes in PYY will be assessed from week 12 to 36.
Changes in PYY will be measured during a 4-h MMT at baseline, week 6, 12 and 36. PYY will be expressed as pmol/L.
Changes in ghrelin at baseline to week 6 will be compared to changes in ghrelin from week 6 to 12. Changes in ghrelin will be assessed from week 12 to 36.
Changes in ghrelin will be measured during a 4-h MMT at baseline, week 6, 12 and 36. Ghrelin will be expressed as pmol/L.
Changes in liver, skeletal muscle and visceral fat composition will be compared to changes in fat composition from week 6 to 12. Changes in fat composition will be assessed from week 12 to 36.
Changes in liver, skeletal muscle and visceral adipose tissue will be assessed by magnetic resonance imaging (MRi) at baseline, week 6, 12 and 36.
Changes in subjective satiety at baseline to week 6 will be compared to changes subjective satiety from week 6 to 12. Changes in subjective satiety will be assessed from week 12 to 36.
Changes in subjective satiety will be assessed by a self-reported visual analog scale (VAS) questionnaire in relation to a 4-h MMT at baseline, week 6, 12 and 36.
Changes in anxiety and depression symptoms at baseline to week 6 compared to changes from week 6 to 12. Changes in anxiety and depression symptoms will be assessed at week 12 to 36.
Changes will be assessed by a self-reported hospital anxiety and depression scale (HADS) questionnaire at baseline, week 6, 12 and 36.
Changes in insulin at baseline to week 6 will be compared to changes in insulin from week 6 to 12. Changes in insulin will be assessed from week 12 to 36.
Changes in insulin will be assessed during a 4-h MMT and during a IM-FSIGT-test at baseline, week 6, 12 and 36. In addition insulin will be meassured every 14 days during the first 12 weeks, and every 4 weeks during the last 24 weeks. Insulin will be expressed in pmol/L.
Changes in C-peptide at baseline to week 6 will be compared to changes in C-peptide from week 6 to 12. Changes in C-peptide will be assessed from week 12 to 36.
Changes in C-peptide will be assessed during a 4-h MMT and during a IM-FSIGT-test at baseline, week 6, 12 and 36. In addition C-peptide will be measured every 14 days during the first 12 weeks, and every 4 weeks during the last 24 weeks. C-peptide will be expressed in pmol/L.
Changes in non-esterified fatty acids (NEFA) at baseline to week 6 will be compared to changes in NEFA from week 6 to 12. Changes in NEFA will be assessed from week 12 to 36.
Changes in NEFA will be assessed during a 4-h MMT and during a IM-FSIGT-test at baseline, week 6, 12 and 36. In addition NEFA will be meassured every 14 days during the first 12 weeks, and every 4 weeks during the last 24 weeks. NEFA will be expressed in micromol/L.
Changes in blood glucose at baseline to week 6 will be compared to changes in blood glucose from week 6 to 12. Changes in blood glucose will be assessed from week 12 to 36.
Changes in blood glucose will be assessed during a 4-h MMT and during a IM-FSIGT-test at baseline, week 6, 12 and 36. Blood glucose will be expressed as mmol/L.
Changes in insulin-like growth factor-binding protein 3 (IGFBP-3) at baseline to week 6 will be compared to changes from week 6 to 12. Changes in IGFBP-3 will be assessed from week 12 to 36.
Changes in IGFBP-1 will be measured during a 4-h MMT at baseline, week 6, 12 and 36. IGFBP-1 will be expressed in ng/mL.