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Trial · NCT04477590

Registered outcomes11

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

ListOutcomeTime frameDescription
PrimaryInsulin sensitivity assessed using intravenous glucose tolerance test12 monthsCurves of insulin-mediated glucose clearance, inhibition of lipolysis, and liver glucose output measured with the use of stable isotope infusion.
PrimaryPost-prandial lipemia assessed by an oral fat tolerance test12 monthsRates of appearance and clearance of liver VLDL-TG, Apolipoprotein B, and fatty acids using stable isotopes.
PrimaryBlood pressure assessed by ECG-gated automated sphygmomanometer12 monthsDetermined immediately after treatments and during the following 24-h using ambulatory blood pressure Holter-type monitors.
PrimaryGlycemic control assessed by 24-h continuous interstitial glucose monitoring36 monthsDetermined by a patch glucose sensor paired with a glucose monitor.
SecondaryBody composition.12 monthsDetermined by bioelectrical impedance to calculate body fat mass and fat free mass.
SecondaryBody mass index12 monthsDetermined by body weight (kg) and height (m) to calculate body mass index (kg/m2)
SecondaryMaximal oxygen consumption during a graded exercise test to exhaustion, assessed by indirect calorimetry12 monthsCalculation of cardiorespitarory fitness
SecondaryResting metabolic rate assessed by indirect calorimetry while lying after an overnight fast12 monthsUsing indirect calorimetry and a ventilated canopy system
SecondaryMaximal rate of fat oxidation assessed by indirect calorimetry during a submaximal exercise test.12 monthsCalculated in grams per min during the incremental cycle ergometer test with the use of indirect calorimetry system
Secondary24-hour monitoring of blood concentrations of metformin, statins, and angiotensin blockers assessed using gas chromatography-mass spectrometry.36 monthsTo study the pharmacokinetics of the habitual medicines used by our subjects during the different experimental conditions
SecondaryThe activity of intramuscular proteins (enzymes) involved in energetics assessed using western blots.36 monthsMeasured in skeletal muscle obtained by percutaneous muscle biopsy.

Source ClinicalTrials.govtrials-2026-11-12-0.5.0

Sources 3

  • ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
  • ClinicalTrials.govNo license stated
  • NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
  • ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
  • ClinicalTrials.govnone stated
  • NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

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