ACute and Chronic Effects of Saxagliptin

Study Overview
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Brief Summary
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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
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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®).

Official Title
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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

Conditions
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Impaired Glucose Tolerance

Intervention / Treatment
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* Drug: saxagliptin
* Other: placebo pill


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Saxagliptin<br>Saxagliptin 5 mg (tablet) at BREAKFEAST | Drug: saxagliptin<br>* 5mg a day for 11-14 weeks<br>* Other names: Onglyza;|
| Placebo Comparator: placebo pill<br>at BREAKFEAST | Other: placebo pill<br>* one tablet a day for 11-14 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Impaired glucose tolerance, Saxagliptin, Cardiovascular risk integrators, Vago-sympathetic activity, Arterial stiffness, Endothelial function