INSUlin Regimens and VASCular Functions

Assistance Publique - Hôpitaux de Paris42 enrolled

Overview

Vago-sympathetic activity, arterial stiffness and endothelial function are integrators of cardiovascular risk. The aim of this pilot study is, in type 2 diabetic patients now requiring insulin, to compare the effects of improving glycemic control on these parameters with 3 different insulin regimens which will act especially at fasting or in post-prandial periods or both. Non invasive explorations will be performed before randomization and after 4 to 5 weeks of insulin therapy, at fasting and each hour after a standardized breakfast.

Vago-sympathetic activity, arterial stiffness and endothelial function are integrators of cardiovascular risk. The effect of controlling fasting or post-prandial blood glucose or both on these parameters has not been studied in type 2 diabetic patients. The aim of this pilot study is to compare the effects of improving fasting or post-prandial blood glucose glycemic control or both with 3 different insulin regimens for 4 to 5 weeks, on vago-sympathetic activity, arterial stiffness and endothelial function. Patients will be recruited in the department of Endocrinology-Diabetology-Nutrition of Jean VERDIER hospital, AP-HP, and the department of Endocrinology and Metabolism of AVICENNE hospital, BOBIGNY, AP-HP, France. After an half day of cardiovascular explorations, 42 patients will be randomized in 3 groups determining their treatment for the following 4-5 weeks : insulin therapy with detemir at dinner or bed time, or with aspart at each meal, or with both of them. Investigations will be performed in the morning 1) at the time of randomisation and 2) 4-5 weeks after the beginning of insulin therapy. We will evaluate at fasting and each hour after a standardized breakfast biological and metabolic parameters, arterial stiffness, endothelial function and nervous autonomic system with non-invasive devices: Sphygmocor®, Finapres®, laser-doppler et Endopat2000®. Body composition will be evaluated with impedance maestri and BodPod®.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Type 2 Diabetes

Interventions

InsulinDRUG

For diabetes treatment: metformin continued with insulin (according to arms)

Eligibility

Sex: ALLMin age: 30 YearsMax age: 72 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Consent patient * Adults from 30 to 72 years old * type 2 diabetic patients for at least 1 year * able to self measure capillary blood glucose * body mass index 20-37 kg/m², * HbA1c 7.1-12% under Metformin and SULFUNYREAS therapy for at least 2 months * anti-hypertensive treatment or dyslipidemic treatment unchanged for 3 months Exclusion criteria: * pregnancy * other antidiabetic medication in the previous 2 months, * anti-hypertensive or lipid-lowering therapies having been changed in the previous 2 months, * insulin allergy, * uncontrolled preproliferative or proliferative diabetic retinopathy * uncontrolled hypertension * renal failure(creatinin clearance \<40 ml/min) * hepatocellular deficiency (prothrombin time \<70%) * anemia * peripheral occlusive arterial disease * cardiac arrhythmia

Locations (1)

Jean Verdier hospital, Department of Endocrinology-Diabetology-Nutrition

Bondy, France

Outcomes

Primary Outcomes

Vago-sympathetic activity, arterial stiffness, endothelial function

Time frame: 4-5 Weeks

Data from ClinicalTrials.gov

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