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Trial · NCT01263717

Registered outcomes12

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

ListOutcomeTime frameDescription
PrimaryLiver Fat6 monthsHepatic fat as measured by magnetic resonance (MR) spectroscopy, and expressed by normalizing lipid to water and expressing as a percent (lipid-to-water percent).
PrimaryVisceral Adipose Tissue6 monthsChange in visceral adipose tissue area as measured by single-slice computed tomography (CT) scan at the L4 vertebra.
SecondaryIntramyocellular Lipid6 months
Intramyocellular lipid (IMCL) as measured by magnetic resonance (MR) spectroscopy of the calf. Soleus IMCL normalized to creatinine (IMCL/Cr based on areas determined by spectroscopy) was measured. The change over 6 months is reported.
SecondaryEndogenous Growth Hormone Secretion6 monthsEndogenous growth hormone (GH) concentrations measured by overnight frequent blood sampling every 20 minutes. Mean overnight GH concentration is given.
SecondaryInsulin Sensitivity6 months
In a subgroup of 1/2 of the subjects, euglycemic hyperinsulinemic clamp will be performed to assess insulin-stimulated glucose uptake. Insulin stimulated glucose uptake (M) calculated using the method of DeFronzo is shown.
SecondaryHbA1c6 monthsHemoglobin A1c.
SecondaryInsulin Like Growth Factor 1 (IGF-I)6 monthsInsulin Like Growth Factor 1 (IGF-I).
SecondaryLipid Panel6 monthsFasting lipids. Triglyceride value is given.
SecondaryCarotid Intimal Medial Thickness (cIMT)6 monthsCarotid Intimal Medial Thickness (cIMT).
SecondaryGlucose Tolerance6 monthsGlucose tolerance as measured by standard oral glucose tolerance test. 2-hour glucose is given.
SecondaryAdiponectin6 monthsadiponectin.
SecondaryHemostatic Markers6 monthsTissue plasminogen activator (tPA) and plasminogen activator inhibitor-1 (PAI-1) measured in serum.

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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