NCT01521312.
| Methods |
Allocation: randomised Intervention model: parallel assignment Masking: double blind (participants and investigators) |
| Participants |
Condition: impaired glucose tolerance Enrolment: 24 Inclusion criteria: social security affiliation; people without tutorship that can freely agree to participate to study; aged 18‐70 years; impaired glucose tolerance diagnosed during the previous month Exclusion criteria: pregnancy; breastfeeding; diabetes; no contraception; BMI > 45 kg/m²; arterial blood pressure > 160/110 mmHg; creatinine clearance < 60 mL/minute; severe hepatocellular insufficiency; chronic respiratory disease; anaemia (haemoglobin < 10 g/dL); peripheral arterial occlusive disease; heart failure; cardiac arrhythmia |
| Interventions |
Intervention: sitagliptin 5 mg, PO Comparator: placebo pill, PO Duration of intervention: 11‐14 weeks |
| Outcomes |
Primary outcomes: vago‐sympathetic activity; arterial stiffness; endothelial function; OGTT Secondary outcomes: NR |
| Study details | Trial terminated early: NR |
| Publication details |
Language of publication: not published Funding: NR Publication status: not published |
| Stated aim of study |
Quote: "Glucose ACCES study will explore the acute and long term (12‐week treatment) effects of saxagliptin in patients with impaired glucose tolerance during fasting and after a standardised breakfast. The investigations will be performed on:
|
| Notes | Trial registered in ClinicalTrials.gov as completed in September 2014. However, it is not published. Authors asked for publication status and data, but no reply provided. As it can take time to obtain data published, the trial is characterised as awaiting classification |