Study Results
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Basic Information
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COMPLETED
PHASE2
24 participants
INTERVENTIONAL
2012-09-30
2014-09-30
Brief Summary
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* glycemic parameters
* on cardiovascular parameters
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Detailed Description
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(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®).
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Saxagliptin
Saxagliptin 5 mg (tablet) at BREAKFEAST
saxagliptin
5mg a day for 11-14 weeks
placebo pill
at BREAKFEAST
placebo pill
one tablet a day for 11-14 weeks
Interventions
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saxagliptin
5mg a day for 11-14 weeks
placebo pill
one tablet a day for 11-14 weeks
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
70 Years
ALL
No
Sponsors
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Assistance Publique - Hôpitaux de Paris
OTHER
Responsible Party
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Principal Investigators
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Paul Valensi, MD
Role: PRINCIPAL_INVESTIGATOR
Jean Verdier Hospital - Department of Endocrinology-Diabetology-Nutrition
Locations
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Jean Verdier hospital, Department of Endocrinology-Diabetology-Nutrition
Bondy, , France
Countries
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References
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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.
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.
Other Identifiers
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P101105
Identifier Type: -
Identifier Source: org_study_id
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