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. 2017 May 10;2017(5):CD012204. doi: 10.1002/14651858.CD012204.pub2

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