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Trial · NCT07913685

Registered outcomes25

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

ListOutcomeTime frameDescription
PrimaryChange in body weight (kg)Week 12Observed change in body weight from baseline to week 12 in the group treated with liraglutide+LCD compared to dietary intervention alone.
SecondaryProportion of subjects losing ≥ 5% of baseline body weightWeek 12Percentage of subjects losing at least 5% of baseline body weight after 12 weeks of treatment.
SecondaryProportion of subjects losing ≥ 10% of baseline body weightWeek 12Percentage of subjects losing at least 10% of baseline body weight after 12 weeks of treatment.
SecondaryChange in waist circumference (cm)Week 12Observed change in waist circumference from baseline to week 12.
SecondaryChange in insulin sensitivity measured in hyperinsulinemic euglycemic clampWeek 12
Observed change in insulin sensitivity measured in hyperinsulinemic euglycemic clamp from baseline to week 12. Insulin sensitivity will be expressed as whole-body glucose uptake normalized for fat-free mass.
SecondaryChange in indirect indices of insulin sensitivity: HOMA-IRWeek 12Observed change in Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) from baseline to week 12.
SecondaryChange in indirect indices of insulin sensitivity: MatsudaWeek 12Observed change in Matsuda index from baseline to week 12.
SecondaryChange in indirect indices of insulin sensitivity: FLAISWeek 12
Observed change in Fasting Laboratory Assessment of Insulin Sensitivity (FLAIS) index from baseline to week 12. FLAIS is an index of insulin sensitivity, calculated from RBC count, ALT, C-peptide, SHBG, adiponectin and IGFBP-1. Higher values of FLAIS reflect higher insulin sensitivity.
SecondaryChange in body composition: total fat mass (kg)Week 12Observed change in total fat mass measured in dual-energy X-ray absorptiometry (DEXA) from baseline to week 12.
SecondaryChange in body composition: total lean mass (kg)Week 12Observed change in total lean mass measured in dual-energy X-ray absorptiometry (DEXA) from baseline to week 12.
SecondaryChange in body composition: visceral adipose tissue mass (g)Week 12Observed change in visceral adipose tissue mass measured in dual-energy X-ray absorptiometry (DEXA) from baseline to week 12.
SecondaryChange in body composition: subcutaneous adipose tissue mass (g)Week 12Observed change in subcutaneous adipose tissue mass measured in dual-energy X-ray absorptiometry (DEXA) from baseline to week 12.
SecondaryChange in liver steatosis: CAPWeek 12Observed change in liver steatosis expressed as controlled attenuation parameter (CAP) measured with noninvasive transient elastography from baseline to week 12.
SecondaryChange in intrahepatic lipid content measured with proton magnetic resonance spectroscopy (%)Week 12Observed change in intrahepatic lipid content measured with 1.5 T proton magnetic resonance spectroscopy from baseline to week 12.
SecondaryChange in intramuscular lipid content measured in proton magnetic resonance spectroscopy (%)Week 12Observed change in intramuscular lipid content measured with 1.5 T proton magnetic resonance spectroscopy from baseline to week 12.
SecondaryChange in cytokine concentrationsWeek 12Observed change in the concentrations of pro- and anti-inflammatory cytokines, adhesion molecules, endothelial markers and adipokines from baseline to week 12.
SecondaryChange in gene expressionWeek 12Observed change in the expression of genes associated with insulin signaling and inflammation in peripheral blood mononuclear cells assessed with qPCR/NGS from baseline to week 12.
SecondaryChange in resting energy expenditureWeek 12Observed change in resting energy expenditure measured in indirect calorimetry from baseline to week 12.
SecondaryChange in Beck Depression Inventory score (BDI)Week 12Observed change in depressive symptoms assessed using BDI from baseline to week 12. Total score: 0-63 points; higher scores reflect greater severity of depressive symptoms.
SecondaryChange in Hospital Anxiety and Depression Scale (HADS)Week 12Observed change in depressive and anxiety symptoms assessed with HADS from baseline to week 12. Total score: 0-42 points; higher scores reflect greater severity of depressive and anxiety symptoms.

Source ClinicalTrials.govtrials-2026-11-12-0.4.0

Sources 3

  • ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
  • ClinicalTrials.govNone 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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