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Trial · NCT00147264

Registered outcomes19

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

ListOutcomeTime frameDescription
Primary(for both interventions): change in IMCL content in the soleus muscle as assessed by 1H-MRI Spectroscopy at baseline and 6 months
SecondaryChange in intra-hepatocellular lipid storage as assessed by 1H-MRI Spectroscopy
SecondaryChange in insulin sensitivity as determined by HOMA index
SecondaryReversal of IFG to normal fasting glucose in participants with IFG
SecondaryChange in 72-hour subcutaneous glucose profile
SecondaryChange in fasting lipid profile (free fatty acids, triglyceride, total cholesterol, low-density lipoprotein (LDL) and high-density lipoprotein (HDL) cholesterol)
Secondary
Change in serum/plasma levels of inflammatory markers (C-reactive protein, adiponectin, tumor necrosis factor a, interleukin 6, leptin, adhesion molecules, plasminogen-activation inhibitor-1, t-PA, global test of fibrinolysis, fibrinogen, homocysteine,
SecondaryChange in beta-cell function as assessed by the Insulin Secretion Index
SecondaryOther efficacy parameters of the AT1 blockade and LGI diet are:
SecondaryChange in waist circumference
SecondaryChange in body composition as assessed by bioelectrical impedance analysis
SecondaryChange in abdominal (visceral) adipose tissue as assessed by MRI
SecondaryChange in resting blood pressure
SecondaryChange in adipocytic cell size determined by grouped diameter distribution in subcutaneous abdominal adipose tissue biopsies
SecondaryChanges in mRNA expression of genes in adipose tissue for genes involved in adipose tissue differentiation, growth, metabolism, cardiovascular function and inflammation.
SecondaryChange in muscle triglyceride content (histochemical examination of muscle biopsies)
SecondaryChange in molecular markers of endoplasmic reticular stress in circulating blood cells
SecondaryEndothelial function as assessed by Doppler ultrasound of the forearm blood flow.
SecondarySystolic and diastolic cardiac function as assessed by echocardiography

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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