Impaired Glucose Tolerance Clinical Trial
Official title:
A Randomized, Double Blind, Placebo Controlled, Pilot Study to Evaluate ACute and Chronic Effects of Saxagliptin on Impaired Glucose Tolerance and micro-and Macro-vascular Integrators
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:
- glycemic parameters
- on cardiovascular parameters
The aim of this pilot study is to compare in patients with impaired glucose tolerance the
effects of saxagliptin versus placebo:
(i) on glucose metabolism (ii) on vago-sympathetic activity, arterial stiffness and
endothelial function. A total of 36 patients will be recruited in the department of
Endocrinology-Diabetology-Nutrition of Jean VERDIER hospital, AP-HP, Bondy, France.
The measurements will be performed in the morning 1) at the time of randomisation (Acute
ACCES study) and 2) 11-14 weeks after the beginning of saxagliptin or placebo (Chronic ACCES
study).
We will evaluate at fasting and each hour after a standardized breakfast:
(i) biological and metabolic parameters. Furthermore, an oral glucose tolerance test will be
performed at the end of the study.
(ii) by non-invasive devices arterial stiffness (Sphygmocor®), endothelial function (ENDOPAT
2000® ), cutaneous microcirculation (laser doppler Perimed ®.PF 5010) and cardiac autonomic
function(task force monitor®).
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
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