| Outcome Measures: |
Primary: Metabolomics changes in blood, Targeted and quantitative analysis by ultra-high-resolution liquid chromatography coupled to triple quadrupole mass spectrometry (UHPL-QqQ/MS). Analysis of specific families of metabolites selected from hypotheses generated by previous exploratory studies: changes in acylcarnitines and other intermediates of mitochondrial β-oxidation and the urea cycle, branched-chain amino acids and biogenic amines, From baseline to week 12|Metabolomics changes in urine, Targeted and quantitative analysis by ultra-high-resolution liquid chromatography coupled to triple quadrupole mass spectrometry (UHPL-QqQ/MS). Analysis of specific families of metabolites selected from hypotheses generated by previous exploratory studies: changes in acylcarnitines and other intermediates of mitochondrial β-oxidation and the urea cycle, branched-chain amino acids and biogenic amines, From baseline to week 12 | Secondary: BMI (body mass index) changes, Measured by body composition analysis, From baseline to to week 12|Changes in insulin resistance, Measured as HOMA-IR (homeostatic model assessment of insulin resistance), From baseline to to week 12|Changes in metabolic control, Measured as HbA1c (glycated hemoglobin), From baseline to to week 12|Changes in Quality of Life: 36-Item Short Form Health Survey (SF-36) questionnaire, The SF-36 has eight scaled scores: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, and mental health. The scores are weighted sums of the questions in each section. Scores range from 0 - 100, lower scores indicate more disability, and higher scores indicate less disability, From baseline to to week 12|Changes in albuminuria, Modifications in albuminuria, measured as albumin excretion rate (AER), From baseline to to week 12
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