ACute and Chronic Effects of Saxagliptin

Assistance Publique - Hôpitaux de Paris24 enrolled

Overview

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®).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Impaired Glucose Tolerance

Interventions

saxagliptinDRUG

5mg a day for 11-14 weeks

placebo pillOTHER

one tablet a day for 11-14 weeks

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

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

Locations (1)

Jean Verdier hospital, Department of Endocrinology-Diabetology-Nutrition

Bondy, France

Outcomes

Primary Outcomes

Vago-sympathetic activity.

This is a pilot study. The vascular measurements will be performed before and during a standardized breakfast.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: First day (inclusion) and after 11-14 weeks of treatment

Data from ClinicalTrials.gov

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