NCT02576288.
Trial name or title | Acronym: SAVORO |
Methods |
Type of trial: safety/efficacy trial Allocation: randomised (3:1) Intervention model: parallel assignment Masking: double blind (participants, carer, investigator, outcomes assessor) Primary purpose: treatment |
Participants |
Condition: FPG 100‐125 mg/dL, HbA1c 5.7‐6.4% or HOMA‐IR ≥ 3.0 and abdominal obesity Enrolment: 40 Inclusion criteria: age 18‐40 years; stable weight (no change > 3% in prior 6 months); waist circumference ≥ 102 cm for men, ≥ 88 cm for women; FPG 100‐125 mg/dL, HbA1c 5.7‐6.4% or HOMA‐IR* ≥ 3.0. Exclusion criteria: regular use of non‐steroidal anti‐inflammatory drug; unwilling to stop non‐steroidal anti‐inflammatory drug; receiving statin or other prescription anti‐inflammatory drugs; diabetes or clinically evident cardiovascular disease; smoking daily or consuming > 200 g alcohol/day |
Interventions |
Intervention: sitagliptin 100 mg, PO, once daily Comparator: placebo, PO, once daily Duration of intervention: 28 days |
Outcomes |
Primary outcome: ultrasound quantification of change in brachial artery flow‐mediated dilation and carotid stiffness (elasticity and dispensability) (immediately before and after 28 days of study therapy) Secondary outcome: deep subcutaneous adipose tissue inflammation (immediately before and after 28 days of study therapy) Other outcomes: systemic markers of inflammation/atherogenic mediators and insulin resistance (immediately before and after 28 days of study therapy) |
Starting date |
Trial start date: January 2016 Trial completion date: July 2017 |
Contact information | Responsible party/principal investigator: Fred Sattler, MD, University of Southern California |
Study identifier | NCT number: NCT02576288 |
Official title | Effects of Sitagliptin on Arterial Vasoreactivity and Proatherogenic Mediators in Obesity |
Stated purpose of study | Quote: "The investigators will evaluate a novel approach using a dipeptidyl peptidase 4 inhibitor (DPP4i) sitagliptin, which blocks signal transduction for monocyte/macrophage activation." |
Notes | Duration of intervention is less than required for inclusion in this review, but the trial will be listed in 'Supplementary table' when completed |