title: Comparison of Adipose Distribution Indices with Gold Standard Body Composition Assessments in the EMPA-REG H2H SU Trial: A Body Composition Sub-Study.
abstract: BACKGROUND
  Excess adiposity contributes to cardiometabolic disease. Although adipose depots can be measured using imaging, implementation remains limited in practice. Data comparing surrogate indices of total and visceral adiposity with gold standard measurements in the context of a clinical trial population are lacking. We explored the relationships between adipose distribution indices and imaging assessments of body composition using baseline data from the EMPA-REG H2H SU™ trial.
  
  
  METHODS
  118 participants from the Phase III trial of empagliflozin 25 mg vs. glimepiride 1-4 mg enrolled in a dedicated sub-study underwent assessment of total fat and fat-free mass by dual x-ray absorptiometry (n = 93) and abdominal visceral (VAT) and subcutaneous adipose tissue by magnetic resonance imaging (n = 99). Correlations with waist circumference (WC), estimated total body fat (eTBF), index of central obesity (ICO), and visceral adiposity index (VAI) were assessed.
  
  
  RESULTS
  eTBF was highly representative of total body fat (Spearman's ρ = 0.73, P < 0.001) but not associated with VAT. WC and ICO were strongly, and VAI to a lesser degree, correlated with VAT (ρ = 0.66, P < 0.001; ρ = 0.52, P < 0.001; ρ = 0.24, P = 0.02, respectively).
  
  
  CONCLUSIONS
  These findings support the use of eTBF and WC or ICO as surrogate indices for total body fat and VAT, respectively, in the absence of gold standard imaging methodology.
authors.affiliation: Department of Internal Medicine, Division of Cardiology, University of Texas Southwestern Medical Center, Dallas, TX, USA. ian.neeland@utsouthwestern.edu.
authors.forename: Ian J
authors.initials: IJ
authors.lastname: Neeland
authors.affiliation: Department of Internal Medicine, Division of Cardiology and Department of Clinical Sciences, University of Texas Southwestern Medical Center, Dallas, TX, USA.
authors.forename: Darren K
authors.initials: DK
authors.lastname: McGuire
authors.affiliation: Sahlgrenska University Hospital, Gothenburg, Sweden.
authors.forename: Björn
authors.initials: B
authors.lastname: Eliasson
authors.affiliation: Steno Diabetes Center, Gentofte, Denmark.
authors.forename: Martin
authors.initials: M
authors.lastname: Ridderstråle
authors.affiliation: Boehringer Ingelheim Pharma GmbH & Co. KG, Biberach, Germany.
authors.forename: Cordula
authors.initials: C
authors.lastname: Zeller
authors.affiliation: Boehringer Ingelheim Pharma GmbH & Co. KG, Ingelheim, Germany.
authors.forename: Hans J
authors.initials: HJ
authors.lastname: Woerle
authors.affiliation: Boehringer Ingelheim Pharma GmbH & Co. KG, Ingelheim, Germany.
authors.forename: Uli C
authors.initials: UC
authors.lastname: Broedl
authors.affiliation: Boehringer Ingelheim Norway KS, Asker, Norway.
authors.forename: Odd Erik
authors.initials: OE
authors.lastname: Johansen
keywords: Body fat distribution; Empagliflozin; Obesity; Sodium glucose co-transporter 2 inhibitor; Visceral adipose tissue