Impaired Glucose Tolerance
Conditions
Keywords
Impaired glucose tolerance, Saxagliptin, Cardiovascular risk integrators, Vago-sympathetic activity, Arterial stiffness, Endothelial function
Brief summary
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
Detailed description
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®).
Interventions
DRUGsaxagliptin
5mg a day for 11-14 weeks
OTHERplacebo pill
one tablet a day for 11-14 weeks
Sponsors
Assistance Publique - Hôpitaux de Paris
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Social security affiliation * Persons without TUTORSHIP that can freely agree to participate to the study * Age between 18 to 70 years * Impaired glucose tolerance diagnosed during the previous month.
Exclusion criteria
* Pregnancy * Breast feeding * Diabetes * No contraception * Body Mass Index \> 45 kg/m² * Arterial blood pressure \> 160/110 mmHg * Creatinine clearance \< 60 ml/min * Severe hepatocellular insufficiency * Chronic respiratory disease * Anaemia (Hemoglobin \< 10 g/dl) * Peripheral arterial occlusive disease * Heart failure * Cardiac arrhythmia
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Vago-sympathetic activity. | First day (inclusion) and after 11-14 weeks of treatment | This is a pilot study. The vascular measurements will be performed before and during a standardized breakfast. |
| arterial stiffness | First day (inclusion) and after 11-14 weeks of treatment | This is a pilot study. The vascular measurements will be performed before and during a standardized breakfast. |
| endothelial function | First day (inclusion) and after 11-14 weeks of treatment | This is a pilot study. The vascular measurements will be performed before and during a standardized breakfast. |
| oral glucose tolerance test. | First day (inclusion) and after 11-14 weeks of treatment | This is a pilot study. The vascular measurements will be performed before and during a standardized breakfast. |
Countries
France
Outcome results
None listed