NCT01548651.

Trial name or title	Effect of Saxagliptin Treatment on Myocardial Fat Content, Left Ventricular Function, and Monocyte Inflammation in Patients with Impaired Glucose Tolerance
Methods	Type of trial: not reported in available protocol, but assume efficacy Allocation: randomised Intervention model: parallel assignment Masking: double blind (participant, carer, investigator, outcomes assessor) Primary purpose: treatment
Participants	Condition: IGT Enrolment: estimated 40 Inclusion criteria: men and women with IGT (i.e. FPG ≤ 125 mg/dL, 2‐h post OGTT 75‐g glucose 140‐199 mg/dL, HbA1c < 6.5% as per American Diabetes Association criteria; age 30‐70 years; using an acceptable method of contraception to avoid pregnancy throughout the study in such a manner that the risk of pregnancy is minimised; BMI 30‐35 kg/m² and stable body weight Exclusion criteria: must not be on anti‐diabetes therapy for treatment of IGT and must have a FPG concentration ≤ 125 mg/dL; T1DM or T2DM (FPG > 125 mg/dL); must not be on or have received metformin, thiazolidinediones, sulphonylureas, DPP‐4 inhibitor or exenatide/liraglutide treatment for IGT at any time; must not be receiving any of the following: thiazide or furosemide diuretics, beta‐blockers or other chronic medications such as hormone replacement therapy with known adverse effects on glucose tolerance levels; people taking systemic glucocorticoids excluded; history of clinically significant heart disease, peripheral vascular disease or pulmonary disease; must not have clinically significant liver disease (aspartate aminotransferase < 2.5 times upper limit of normal, alanine transaminase < 2.5 times upper limit of normal, alkaline phosphatase < 2.5 times upper limit of normal), kidney disease (serum creatinine < 1.5 mg/dL in men and 1.4 mg/dL in women) or significant anaemia (hematocrit < 34 vol%); history of any serious hypersensitivity reaction to saxagliptin or a DPP‐4 inhibitor; concomitant treatment with systemic cytochrome P450 3A4 inducers; pregnant or breastfeeding
Interventions	Intervention: saxagliptin 5 mg/day, PO Comparator: placebo daily Duration of intervention: 6 months
Outcomes	Primary outcomes: myocardial and hepatic fat content (%) (at 6 months); % change in hepatic fat and myocardial fat from baseline as measured by magnetic resonance imaging and spectroscopy Secondary outcomes: left ventricular ejection fraction (%) (at 6 months); % change in left ventricular ejection fraction from baseline as measured by magnetic resonance imaging; monocyte inflammatory protein NFkappaB (%) (at 6 months); % change in monocyte inflammatory proteins NFkappaB from baseline Other outcomes: none
Starting date	Trial start date: February 2012 Trial completion date: December 2016 (final data collection date for primary outcome measure)
Contact information	Responsible party/principal investigator: Mandeep Bajaj, MD, Baylor College of Medicine
Study identifier	NCT number: NCT01548651
Official title	Effect of Saxagliptin Treatment on Myocardial Fat Content, Left Ventricular Function, and Monocyte Inflammation in Patients with Impaired Glucose Tolerance
Stated purpose of study	Quote: "The purpose of the study is to examine the effect of saxagliptin, an anti‐diabetes medication, on hepatic and myocardial fat content and monocyte inflammation in patients with Impaired Glucose Tolerance (IGT)."
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