Outcome
Type |
Measure |
Description |
Time frame |
Safety issue |
Other |
Change (week 0 vs week 16) in android obesity |
Levels of total and abdominal fat (volume in cm3) will be measured at baseline and post-intervention (16 week) by DEXA in all participants. Associations between changes in study outcomes and in body fat distribution will be assessed by correlational and multiple regression analyses |
week 0 and week 16 (112 days) |
|
Other |
Gut microbiota |
These are exploratory analyses in a subset of participants only. Deep 16S rDNA metagenomic analysis (in feces) as well as analyses of microbiota metabolites and endogenous bioactive lipid mediators in plasma will be used as surrogates of gut microbiota composition and function in these exploratory analyses of between group differences. Analyses will be adjusted for baseline values. |
16 week (112 days) |
|
Primary |
1. Serum 4-hour post-prandial TG concentrations |
Serum TG concentrations (mmol/l) will be measured 4 hours after ingestion of a fatty meal (fat load), at the end of the 16-week intervention in all subjects in each group. The fat load will be conducted 48 hours after the last exercise training session in the PA groups (hence at 16.2 weeks, or 114 days). Analyses will be adjusted for 4-hr postprandial TG values measured at baseline. |
16.3 week (114 days) |
|
Secondary |
Serum fasting TG concentrations |
Fasting serum TG concentrations (mmol/l) will be measured at the end of the 16-wk intervention in all subjects in each group. Analyses will be adjusted for fasting TG values measured at baseline. |
16 week (112 days) |
|
Secondary |
Serum fasting TG concentrations |
Fasting serum TG concentrations (mmol/l) will be measured 2 days after the end of the 16-wk intervention in all subjects in each group (hence 16.3 weeks, or 114 days). Analyses will be adjusted for fasting TG values measured at baseline. |
16.3 week (114 days) |
|
Secondary |
Serum fasting LDL-C concentrations |
Fasting serum LDL-C concentrations (mmol/l) will be measured at the end of the 16-wk intervention in all subjects in each group. Analyses will be adjusted for fasting LDL-C values measured at baseline. |
16 week (112 days) |
|
Secondary |
Serum fasting LDL-C concentrations |
Fasting serum LDL-C concentrations (mmol/l) will be measured 2 days after the end of the 16-wk intervention in all subjects in each group (hence 16.3 weeks, or 114 days). Analyses will be adjusted for fasting LDL-C values measured at baseline. |
16.3 week (114 days) |
|
Secondary |
Serum fasting HDL-C concentrations |
Fasting serum HDL-C concentrations (mmol/l) will be measured at the end of the 16-wk intervention in all subjects in each group. Analyses will be adjusted for fasting HDL-C values measured at baseline. |
16 week (112 days) |
|
Secondary |
Serum fasting HDL-C concentrations |
Fasting serum HDL-C concentrations (mmol/l) will be measured 2 days after the end of the 16-wk intervention in all subjects in each group (hence 16.3 weeks, or 114 days). Analyses will be adjusted for fasting HDL-C values measured at baseline. |
16.3 week (114 days) |
|
Secondary |
Serum fasting CRP concentrations |
Fasting serum CRP concentrations (mg/ l) will be measured at the end of the 16-wk intervention in all subjects in each group. Analyses will be adjusted for fasting CRP values measured at baseline. |
16 week (112 days) |
|
Secondary |
Serum fasting CRP concentrations |
Fasting serum CRP concentrations (mg/ l) will be measured 2 days after the end of the 16-wk intervention in all subjects in each group (hence 16.3 weeks, or 114 days). Analyses will be adjusted for fasting CRP values measured at baseline. |
16.3 week (114 days) |
|
Secondary |
Serum fasting adiponectin concentrations |
Fasting serum adiponectin concentrations (mg/l) will be measured at the end of the 16-wk intervention in all subjects in each group. Analyses will be adjusted for fasting adiponectin values measured at baseline. |
16 week (112 days) |
|
Secondary |
Serum fasting adiponectin concentrations |
Fasting serum adiponectin concentrations (mg/l) will be measured 2 days after the end of the 16-wk intervention in all subjects in each group (hence 16.3 weeks, or 114 days). Analyses will be adjusted for fasting adiponectin values measured at baseline. |
16.3 week (114 days) |
|
Secondary |
Serum fasting IL-6 concentrations |
Fasting serum IL-6 concentrations (pmol/l) will be measured at the end of the 16-wk intervention in all subjects in each group. Analyses will be adjusted for fasting IL-6 values measured at baseline. |
16 week (112 days) |
|
Secondary |
Serum fasting IL-6 concentrations |
Fasting serum IL-6 concentrations (pmol/l) will be measured 2 days after the end of the 16-wk intervention in all subjects in each group (hence 16.3 weeks, or 114 days). Analyses will be adjusted for fasting IL-6 values measured at baseline. |
16.3 week (114 days) |
|
Secondary |
Serum fasting IL-18 concentrations |
Fasting serum IL-18 concentrations (pmol/l) will be measured at the end of the 16-wk intervention in all subjects in each group. Analyses will be adjusted for fasting IL-18 values measured at baseline. |
16 week (112 days) |
|
Secondary |
Serum fasting IL-18 concentrations |
Fasting serum IL-18 concentrations (pmol/l) will be measured 2 days after the end of the 16-wk intervention in all subjects in each group (hence 16.3 weeks, or 114 days). Analyses will be adjusted for fasting IL-18 values measured at baseline. |
16.3 week (114 days) |
|
Secondary |
Serum fasting TNF-alpha concentrations |
Fasting serum TNF-alpha concentrations (pmol/l) will be measured at the end of the 16-wk intervention in all subjects in each group. Analyses will be adjusted for fasting TNF-alpha values measured at baseline. |
16 week (112 days) |
|
Secondary |
Serum fasting TNF-alpha concentrations |
Fasting serum TNF-alpha concentrations (pmol/l) will be measured 2 days after the end of the 16-wk intervention in all subjects in each group (hence 16.3 weeks, or 114 days). Analyses will be adjusted for fasting TNF-alpha values measured at baseline. |
16.3 week (114 days) |
|
Secondary |
Systolic blood pressure (SBP) |
SBP (mmHg) will be measured at the end of the 16-wk intervention in all subjects in each group. Analyses will be adjusted for SBP values measured at baseline. |
16 week (112 days) |
|
Secondary |
Systolic blood pressure (SBP) |
SBP (mmHg) will be measured 2 days after the end of the 16-wk intervention in all subjects in each group (hence 16.3 weeks, or 114 days). Analyses will be adjusted for SBP values measured at baseline. |
16.3 week (114 days) |
|
Secondary |
Diastolic blood pressure (DBP) |
DBP (mmHg) will be measured at the end of the 16-wk intervention in all subjects in each group. Analyses will be adjusted for DBP values measured at baseline. |
16 week (112 days) |
|
Secondary |
Diastolic blood pressure (DBP) |
DBP (mmHg) will be measured 2 days after the end of the 16-wk intervention in all subjects in each group (hence 16.3 weeks, or 114 days). Analyses will be adjusted for DBP values measured at baseline. |
16.3 week (114 days) |
|
Secondary |
Maximal oxygen consumption (VO2max) |
Maximal oxygen consumption, a metric of cardiorespiratory fitness, will be measured by a modified Bruce protocol at the end of the 16-wk intervention in all subjects in each group. Analyses will be adjusted for VO2max values measured at baseline. |
16 week (112 days) |
|
Secondary |
Left ventricular (LV) global longitudinal strain |
LV global longitudinal strain in % will be measured using transthoracic echocardiogram and speckle tracking for systolic and diastolic strain/strain rates. Analyses will be adjusted for LV global longitudinal strain values measured at baseline. |
16 week (112 days) |
|
Secondary |
Right ventricular (RV) global longitudinal strain |
RV global longitudinal strain in % will be measured using transthoracic echocardiogram and speckle tracking for systolic and diastolic strain/strain rates. Analyses will be adjusted for RV global longitudinal strain values measured at baseline. |
16 week (112 days) |
|
Secondary |
Cardiac chamber volumes |
Cardiac chamber volumes (cm3) will be measured using transthoracic echocardiogram with pulse-wave, continuous-wave and tissue Dopplers. Analyses will be adjusted for cardiac chamber volumes measured at baseline. |
16 week (112 days) |
|