Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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:
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®).
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Saxagliptin | Experimental | Saxagliptin 5 mg (tablet) at BREAKFEAST |
|
| placebo pill | Placebo Comparator | at BREAKFEAST |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| saxagliptin | Drug | 5mg a day for 11-14 weeks |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Vago-sympathetic activity. | This is a pilot study. The vascular measurements will be performed before and during a standardized breakfast. | First day (inclusion) and after 11-14 weeks of treatment |
| arterial stiffness | This is a pilot study. The vascular measurements will be performed before and during a standardized breakfast. | First day (inclusion) and after 11-14 weeks of treatment |
| endothelial function | This is a pilot study. The vascular measurements will be performed before and during a standardized breakfast. | First day (inclusion) and after 11-14 weeks of treatment |
| oral glucose tolerance test. | This is a pilot study. The vascular measurements will be performed before and during a standardized breakfast. | First day (inclusion) and after 11-14 weeks of treatment |
Not provided
Not provided
Inclusion Criteria:
Exclusion criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Paul Valensi, MD | Jean Verdier Hospital - Department of Endocrinology-Diabetology-Nutrition | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jean Verdier hospital, Department of Endocrinology-Diabetology-Nutrition | Bondy | 93140 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34420816 | Derived | Rezki A, Cosson E, Fysekidis M, Chiheb S, Vicaut E, Valensi P. Acute and long-term effects of saxagliptin on a set of cardiovascular targets measured at fasting and post-prandially in obese patients with impaired glucose tolerance: A placebo-controlled study. Nutr Metab Cardiovasc Dis. 2021 Sep 22;31(10):2945-2958. doi: 10.1016/j.numecd.2021.06.017. Epub 2021 Jul 1. | |
| 33618922 |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D018149 | Glucose Intolerance |
| ID | Term |
|---|---|
| D006943 | Hyperglycemia |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C502994 | saxagliptin |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| placebo pill | Other | one tablet a day for 11-14 weeks |
|
| Rezki A, Fysekidis M, Chiheb S, Vicaut E, Cosson E, Valensi P. Acute and long-term effects of saxagliptin on post-prandial glycemic response in obese patients with impaired glucose tolerance. Nutr Metab Cardiovasc Dis. 2021 Apr 9;31(4):1257-1266. doi: 10.1016/j.numecd.2020.12.025. Epub 2020 Dec 31. |